[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pfizer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":683},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,140,0,25,[9,44,68,94,116,138,172,199,227,254,292,317,339,369,396,424,448,482,508,532,561,585,618,639,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100646886","phase-4-a-study-to-find-out-if-the-medicine-called-rimegepant-is-safe-for-adults-in-india-100646886",false,"NCT07685769","A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India","AN OPEN-LABEL MULTICENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF RIMEGEPANT 75 MG ODT FOR ACUTE TREATMENT OF MIGRAINE IN ADULT PARTICIPANTS IN INDIA WITH PREVIOUS INSUFFICIENT RESPONSE TO TRIPTANS","Inclusion Criteria\n\nParticipants are eligible to be included in this study only if all of the following criteria apply:\n\nAge and Reproductive Status:\n\n1. 18 years of age or older who meet the reproductive criteria.\n\n   Disease Characteristics:\n2. Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:\n\n   1. At least 5 attacks fulfilling criteria 1-3:\n\n      1. Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated).\n      2. Headache has at least 2 of the following 4 characteristics:\n\n         * Unilateral location\n         * Pulsating quality\n         * Moderate or severe pain intensity\n         * Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)\n      3. During headache, at least 1 of the following:\n\n         -Nausea and\u002For vomiting\n         * Photophobia and phonophobia\n   2. Not better accounted for by another ICHD-3 diagnosis.\n3. Participants experience 4-14 migraine days \u002F month and fewer than 7 non-migraine headache days \u002F month on average and overall, less than 15 days with headache (migraine or non-migraine) per month across the 3 months prior to screening.\n4. Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to screening visit, and the dose is not expected to change during the study.\n5. Participants have previous insufficient response and\u002For prior intolerance to at least one triptan or documented contraindication to the use of triptan.\n\n   1. Insufficient response - Previous treatment with one or more triptan has yielded no, unsatisfactory or inconsistent therapeutic effect (eg, recurrent, incomplete relief of migraine related symptoms \\[including pain, nausea, photophobia, phonophobia etc\\] at 2 hours post dose, non-sustained relief of migraine related symptoms through 24 hours post dose, etc), after repeated dosing (≥2 attempts) at recommended dose level.\n   2. Prior intolerance - treatment with triptan has been interrupted because of an adverse event that made continuation of the drug intolerable for the individual.\n\n      -Prior triptan associated overuse headache\n\n      -Arrhythmia associated with prior triptan use\n\n      -Chest\u002Fthroat\u002Fneck\u002Fjaw pain, tightness, pressure or heaviness associated with prior use of triptan\n\n      -Gastrointestinal ischemia or peripheral vasospastic reaction associated with prior use of triptan\n      * Serotonin syndrome associated with prior triptan use\n   3. Documented contraindication to triptans -\n\n      1. Documented hypersensitivity to triptan\n      2. Cardiovascular events, conditions and procedures considered contraindications to the use of triptan medications.\n\n   i. Events: Myocardial infractions, prior cardiac arrest, transient ischemic attack, cerebrovascular accident (Intracerebral haemorrhage, intracranial haemorrhage, subarachnoid haemorrhage, ischemic stroke) ii. Conditions: Angina pectoris, coronary artery vasospasm, ischemic coronary artery disease, peripheral artery disease, ischemic bowel disease, cardiac conduction disorders (life threatening arrhythmia\u002Fheart block) iii. Procedure: Angioplasty, coronary artery bypass grafting, carotid endarterectomy 3) Uncontrolled hypertension\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   * PHQ-8 total score ≥15\n   * Suicidal ideation and behavior (one, or more, of the below is exclusionary):\n\n     * a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;\n     * suicidal ideation associated with actual intent and\u002For a method or plan at any time in their lifetime: any positive response on items 3, 4 or 5 of the C-SSRS;\n     * any previous lifetime history of suicidal behavior: \"Yes\" to answer to any of the suicidal behavior items of the C-SSRS.\n   * Current diagnosis of schizophrenia, bipolar, or borderline personality disorder.\n   * History of severe drug allergy, including anaphylaxis or known hypersensitivity or intolerance to rimegepant or any of its excipients.\n2. Any of the following:\n\n   * History of any trigeminal autonomic cephalalgia (eg. cluster headache, Short-lasting, Unilateral, Neuralgiform headache attacks with Conjunctival injection and Tearing \\[SUNCT\\], Short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms \\[SUNA\\], hemicrania continua, paroxysmal hemicrania).\n   * Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \\[CRPS\\]); Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety.\n\n   Prior\u002FConcomitant Therapy:\n3. Current use of any prohibited concomitant medication(s).\n4. History of use of ergotamine medications or triptans for greater than\u002Fequal to 10 days per month on a regular basis for greater than\u002Fequal to 3 months, or history of non-narcotic analgesic intake for greater than\u002Fequal to 15 days per month for greater than\u002Fequal to 3 months (eg, acetaminophen, non-steroidal anti-inflammatory drugs \\[NSAIDs\\], gabapentin) for other pain indications.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n5. Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days or 5 half-lives of investigational drug (whichever is longer) prior to Baseline Visit. Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days or 5 half-lives (whichever is longer) prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.\n\n   Diagnostic Assessments:\n6. ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:\n\n   * eGFR (using CKD-EPI-Scr-Scys Combined) \\\u003C30 mL\u002Fmin\u002F1.73m²\n   * Total bilirubin \\>1.5 × ULN (may be repeated once, with fractionation, for confirmation during the Screening Phase, and direct bilirubin \\>ULN is exclusionary if Gilbert's syndrome is suspected)\n   * AST (SGOT) or ALT (SGPT) \\>2.0 × ULN\n\n   Other Exclusion Criteria:\n7. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a multicenter, single-arm, open-label Phase 4 study evaluating the safety and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.",[27],"Acute Treatment of Migraine",[29,30],"migraine","Rimegepant","RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-07-24",{"date":39,"type":21},"2028-01-04",{"name":41,"class":42},"Pfizer","INDUSTRY",2,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100644851","phase-1-a-study-to-learn-how-the-study-medicine-called-atirmociclib-is-handled-by-the-body-in-people-with-normal-liver-function-and-different-levels-of-liver-disease-100644851","NCT07677358","A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease","A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION","Inclusion criteria including but not limited to:\n\n* BMI of 17.5-40 kg\u002Fm2; and a total body weight \\>50 kg (110 lb).\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Capable of giving signed informed consent.\n\nNormal hepatic function group only:\n\n\\- Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.\n\nHepatic impairment groups only:\n\n\\- Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.\n\nExclusion criteria including but not limited to:\n\n* Any condition or history of surgery possibly affecting drug absorption.\n* Use of prohibited prior or concomitant medications.\n\nNormal hepatic function group only:\n\n\\- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n\nHepatic impairment groups only:\n\n\\- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.",true,{"count":53,"type":21},28,[55],"PHASE1","The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.\n\nThe study is seeking participants who are:\n\n* Aged 18 years or older\n* Have a BMI of 17.5 to 40 kg\u002Fm2, and body weight more than 50 kg.\n* Have normal liver function or have stable mild, moderate, or severe liver disease\n\nParticipants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.\n\nParticipants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.",[58,59,60],"Hepatic Impairment","Healthy, Hepatic Insufficiency","Healthy Adults",{"date":34,"type":35},{"date":63,"type":35},"2026-06-29",{"date":65,"type":21},"2027-09-10",{"name":41,"class":42},3,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":51,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100605263","phase-3-beatrix-a-study-to-learn-about-a-group-b-streptococcus-vaccine-in-healthy-pregnant-women-and-their-babies-100605263","NCT07160244","BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS","Key Inclusion criteria- Maternal:\n\n* Healthy pregnant women ≤49 years of age who are between 24 0\u002F7 and 36 0\u002F7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.\n* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.\n* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.\n* Capable of giving personal signed informed consent.\n* Willing to give informed consent for her infant to participate in the study.\n\nKey Exclusion criteria- Maternal:\n\n* Prepregnancy body mass index (BMI) of \\>40 kg\u002Fm2.\n* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.\n* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.\n* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.\n* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).\n\nKey Inclusion criteria- Infant Participants\n\n\\- Evidence of a signed and dated ICD signed by the parent(s)\u002Flegally authorized representative or legal guardian\n\nKey Exclusion Criteria - Infant Participants:\n\n\\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.\n\nKey Exclusion Criteria - Infant immunogenicity subset Participants:\n\n\\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.\n\nRefer to the study contact for further eligibility details","1 Day","49 Years",{"count":78,"type":21},6000,[80],"PHASE3","BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.\n\nThis study is seeking healthy pregnant participants:\n\n* aged 49 or younger who can join.\n* between 24 and 36 weeks of gestation (\"Gestational age\" is a medical term used to describe how far along your pregnancy is)\n* had a fetal ultrasound examination performed with no major fetal abnormalities observed\n* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.\n\nA subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and\u002For pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and\u002For toddler (booster) doses.",[83],"Healthy",[85],"group B streptococcus, maternal immunization, vaccine",{"date":87,"type":35},"2026-08-20",{"date":89,"type":35},"2025-08-25",{"date":91,"type":21},"2029-03-02",{"name":41,"class":42},212,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":101,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100652927","a-study-to-learn-about-the-outcomes-between-study-medicines-enzalutamide-and-darolutamide-among-men-with-metastatic-castration-sensitive-prostate-cancer-mcspc-100652927","NCT07779590","A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Real-World Outcomes Among Patients Receiving Enzalutamide Plus ADT or Darolutamide Plus ADT in Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Patients included in the Flatiron Prostate Cancer Panoramic dataset:\n\n   1. Has an International Classification of Diseases (ICD) diagnosis of PC (ICD-9 185x or ICD-10 C61x)\n   2. At least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011\n   3. Has evidence of diagnosis of PC with an initial or metastatic diagnosis date.\n2. Evidence of mCSPC diagnosis date, as defined below:\n\n   a. The mCSPC diagnosis date is determined using information on the date of metastatic diagnosis and the CSPC status. The data of metastatic diagnosis is the earliest date of the first confirmation of metastatic prostate cancer using the following hierarchy, where available: 1) Biopsy specimen collection date from the pathology report; 2) Physician reported date of biopsy; 3) Date of the radiology scan that indicated metastatic disease, if it was later confirmed by the physician; 4) Physician reported date of metastatic diagnosis. CSPC status is determined based on the following hierarchical evidence sources: 1) metastatic diagnosis date (if metastatic at initial diagnosis); 2) Explicit clinician documentation of CSPC; 3) Earliest ADT start date; 4) Clinician documented response or PSA decline while on ADT\n3. Has evidence of treatment with enzalutamide or darolutamide in combination with ADT in the 1L mCSPC setting , on or after 01 August 2022.\n\n   Note: The index date is the start of the ARPI in combination with ADT (i.e., the first episode of ARPI treatment, which can occur up to 90 days after initiation of 1L therapy if ADT is initiated before the ARPI).\n4. Index date is no more than 30 days prior to or 6 months after the mCSPC diagnosis date\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Birth sex reported as female or unknown\n2. Age \\\u003C18 years at index date\n3. Evidence of receiving a clinical study drug on or prior to index date\n4. Diagnosed with neuroendocrine and\u002For small cell PC on or prior to index\n5. Diagnosed with additional malignancies, excluding nonmelanoma skin cancer, at any time prior to index date\n6. Index date \\\u003C6 months prior to data cutoff date\n7. Received multiple ARPIs or ARPI in combination with any drug other than ADT or first-generation anti-androgen treatments prior to and up to 28 days after index date\n8. Evidence of ADT or first-generation anti-androgen treatment between 1 year and 91 days prior to index date\n9. Evidence of an orchiectomy occurring more than 90 days prior to index date\n10. Evidence of CRPC any time prior or up to 90 days after the index date\n11. Evidence of treatments for mCRPC on or prior to index date\n12. Has a Line 0 as defined by Flatiron line of therapy (LOT) business rules, indicating potentially missing treatment data at the start of mCSPC setting\n13. Received docetaxel prior to and up to 120 days after index date","MALE",{"count":103,"type":21},4700,"OBSERVATIONAL","The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT). ADT is a hormone therapy used to stop testosterone from being released or to prevent it from acting on prostate cells. The study includes men with metastatic castration-sensitive prostate cancer (mCSPC). This is a cancer that has spread outside the prostate to other parts of the body, but can still be successfully managed by lowering male hormones like testosterone. The study uses data from the Flatiron's Prostate Cancer Panoramic Database. This data base contains information on prostate cancer patients such as their clinical characteristics, lab, vitals, treatments and outcomes.\n\nThis study is seeking participants included in the Flatiron Prostate Cancer Panoramic dataset who:\n\n* Have a diagnosis of prostate cancer (PC) that has spread to other parts of the body\n* With at least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011\n* Has proof of treatment with enzalutamide or darolutamide in combination with ADT as a first line treatment\n* The treatment with enzalutamide or darolutamide in combination with ADT is no more than 30 days prior to or 6 months after the mCSPC diagnosis date\n\nAll participants in this study received at least 1 dose of enzalutamide or darolutamide in combination with ADT. The experiences of the participants receiving the enzalutamide or darolutamide will be looked at.\n\nParticipants will take part in this study for at least 6 months. During this time, they will have at least 2 documented clinic visits from 01 January 2011 to 31 March 2026. These visits will be updated if newer information becomes available at the time of the analysis.",[107],"Metastatic Castration Sensitive Prostate Cancer (mCSPC)","NOT_YET_RECRUITING","2026-08-18",{"date":34,"type":35},{"date":112,"type":21},"2026-09-01",{"date":114,"type":21},"2026-11-15",{"name":41,"class":42},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":43},"100652484","phase-3-a-study-to-learn-about-the-study-medicine-called-tilrekimig-in-people-with-severe-asthma-100652484","NCT07772921","A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA","Inclusion Criteria\n\nMust meet the following asthma criteria:\n\n1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and \u002F or local guidelines.\n2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\\\u003C24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma with within 12 months of the screening visit.\n3. Positive bronchodilator responsiveness of FEV1 or FVC \\>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local treatment practices) after inhaling 400 µg of salbutamol\u002Falbuterol (or equivalent SABA) at least once for spirometry conducted during screening period.\n\n   Other Inclusion Criteria:\n4. Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and \u002F or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening).\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to, chronic obstructive pulmonary disease, other emphysematous lung disease such as alpha-1 antitrypsin disease, cystic fibrosis, emphysema, pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis, pulmonary embolism.\n2. Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.\n\n   Prior\u002FConcomitant Therapy:\n3. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit.\n4. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40\u002FOX40L, IL-13, IL-33 \u002F ST2) or targeted synthetic drugs for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.\n5. Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).\n6. Bronchial thermoplasty within the previous 24 months.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n7. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Previous participation in other tilrekimig studies or participation in studies of other investigational products (drug or vaccine) at any time during this study.","12 Years","80 Years",{"count":126,"type":21},1100,[80],"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.\n\nThe study is seeking participants who:\n\n* Have a history of severe asthma for at least 12 months\n* Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic.\n\nThe study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.",[130],"Asthma","2026-08-14",{"date":32,"type":35},{"date":134,"type":21},"2026-08-24",{"date":136,"type":21},"2029-09-04",{"name":41,"class":42},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":160,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100642828","phase-2-a-study-of-pf-08653945-and-pf-08653944-in-adults-with-overweight-or-obesity-solis-1-100642828","NCT07575932","A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)","A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOSE RANGING, DOSE-FINDING, UMBRELLA STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08653945 AND PF-08653944, ALONE OR IN COMBINATION, IN ADULTS WITH OVERWEIGHT OR OBESITY (SOLIS-1)","SOLIS-1","Inclusion Criteria:\n\nEligible participants for this study include:\n\n* adults aged 18 years or older with\n* obesity (BMI of 30.0 kg\u002Fm2 to 50.0 kg\u002Fm2) or with\n* overweight (BMI of 27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit.\n\nExclusion Criteria:\n\nParticipants who are not eligible include those with diabetes mellitus, a body weight change of \\>5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.",{"count":147,"type":21},872,[149],"PHASE2","This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).",[152,153,154,155,156,157,158,159],"Overweight","Obesity","Overweight and\u002For Obesity","Overweight or Obesity","Overnutrition","Nutrition Disorders","Nutritional and Metabolic Diseases","Body Weight",[156,157,158,159,153,152,161,162,163],"GLP-1RA","Amylin","DACRA",{"date":165,"type":35},"2026-08-17",{"date":167,"type":35},"2026-05-11",{"date":169,"type":21},"2028-01-05",{"name":41,"class":42},65,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":179,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100642707","phase-3-symbiotic-gyn-18-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-advanced-or-recurrent-mmr-proficient-endometrial-cancer-100642707","NCT07578649","Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer","AN INTERVENTIONAL PHASE 3, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH ADVANCED OR RECURRENT MISMATCH REPAIR PROFICIENT ENDOMETRIAL CANCER","Inclusion Criteria:\n\n* Women ≥18 years of age who are confirmed not pregnant at screening.\n* Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded.\n* Newly diagnosed FIGO Stage III disease with measurable disease per RECIST v1.1, newly diagnosed FIGO Stage IV disease with or without measurable disease, or recurrent disease with or without measurable disease for which curative treatment with surgery and\u002For radiotherapy is unlikely.\n* For participants with recurrent disease, prior adjuvant systemic anti-cancer therapy is allowed if relapse occurred more than 6 months after the last dose.\n* Must provide tumor tissue for prospective central assessment of MMR and p53 status.\n* Proficient mismatch repair (pMMR) endometrial cancer as determined by central testing.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Life expectancy of at least 12 weeks.\n* Adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Prior systemic therapy for first-line advanced or recurrent endometrial cancer.\n* Prior immunotherapy or anti-angiogenic therapy.\n* Deficient mismatch repair (dMMR) endometrial cancer by central testing.\n* Active or untreated central nervous system (CNS) metastases; participants with previously treated and clinically stable brain metastases may be eligible if not requiring steroids and without evidence of progression.\n* Clinically significant risk of bleeding or fistula, including a history of severe bleeding disorders.\n* History of another malignancy within 3 years, except for cancers with negligible risk of recurrence or death.\n* History of allogeneic organ or hematopoietic stem cell transplantation; active autoimmune disease requiring systemic treatment within the past 2 years; or history of immunodeficiency\n* Interstitial lung disease, pneumonitis, or clinically significant pulmonary disease\n* Uncontrolled or significant cardiovascular, metabolic, renal, hepatic, or vascular disease\n* Active or uncontrolled infection.\n* Recent major surgery or severe trauma within protocol-defined washout periods.","FEMALE",{"count":181,"type":21},600,[80],"This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing.\n\nOur bodies have a built-in DNA \"spell-checker,\" called the mismatch repair (MMR) system, that fixes genetic mistakes. In most endometrial cancers, this system works normally, and these cancers are called MMR-proficient (pMMR). However, pMMR tumors are harder for the immune system to recognize and attack. When endometrial cancer has spread beyond the uterus or comes back after previous treatment, it is called advanced or recurrent endometrial cancer. This study is for adults with mismatch repair-pMMR advanced or recurrent endometrial cancer.\n\nParticipants must meet key criteria, including:\n\n* Women who are 18 years or older, and not pregnant at the time of joining the study\n* pMMR endometrial cancer only\n* Measurable Stage III disease, Stage IV disease (with or without measurable disease) per FIGO staging, a system doctors use to describe how far cancer has spread in the body, or recurrent (with or without measurable disease) endometrial cancer\n* Has not received chemotherapy except for chemotherapy given after the main surgery and more than 6 months before relapse\n* Be in good enough health to receive study treatment. Approximately 600 adult women will be enrolled. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups, with about half in each group. The study is open, meaning both the doctors and participants know what treatment is being given. Participants will receive their assigned treatment through intravenous infusions (medicine is given directly into a vein). The treatment will be given in cycles.\n\nExperimental Group will receive new study medicine called PF-08634404 plus chemotherapy. It will be followed by PF 08634404 alone for up to 2 years (35 cycles).\n\nControl Group will receive an approved medicine called pembrolizumab plus chemotherapy. It will be followed by pembrolizumab alone for up to 2 years (20 cycles).\n\nThe study will include regular visits for:\n\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will come for a final visit within a month to check their health and review any reactions.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records. This helps check health and any new treatments.\n* Tests will be done every 9 weeks during the first 104 weeks to see how the cancer is responding. After that, tests will be done every 12 weeks.",[185,186],"Endometrial Neoplasms","Endometrial Cancer",[188,185,189,190,191],"Recurrent Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced or Recurrent Endometrial Cancer","pMMR",{"date":165,"type":35},{"date":194,"type":21},"2026-10-09",{"date":196,"type":21},"2031-01-30",{"name":41,"class":42},1,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100639041","phase-3-a-study-to-learn-about-the-study-medicine-called-berobenatide-pf-08653944-in-people-with-overweight-or-obesity-100639041","NCT07595549","A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)","Inclusion Criteria:\n\n* Aged ≥18 years.\n* BMI of: ≥30 kg\u002Fm2 or ≥27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.\n\nExclusion Criteria:\n\n* Have a self-reported body weight change greater than 5% within 90 days prior to Screening.\n* Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).",{"count":207,"type":21},954,[80],"The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.\n\nAbout 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.\n\nPeople will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.",[153,154,152],[156,157,212,213,159,214,215,216,152,153,158,217,218,219],"Diabetes Mellitus, Type 2","Type 2 Diabetes","Diabetes Mellitus","Glucose Metabolism Disorders","Endocrine System Diseases","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Metabolic Diseases",{"date":165,"type":35},{"date":222,"type":35},"2026-06-10",{"date":224,"type":21},"2028-06-21",{"name":41,"class":42},38,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":242,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100632897","phase-1-phase-1-study-of-pf-08046033-in-advanced-solid-tumors-100632897","NCT07519655","Phase 1 Study of PF-08046033 in Advanced Solid Tumors","A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.\n2. Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).\n3. Participants must have measurable disease.\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.\n\nExclusion Criteria:\n\n1. Participants with known clinically active central nervous system (CNS) metastases.\n2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.\n3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.\n4. Untreated clinically significant thromboembolic disease.\n5. Previous exposure to GPNMB-targeted therapy.\n6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.",{"count":235,"type":21},250,[55],"This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.\n\nThe study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.\n\nThe study has two parts:\n\nIn the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.\n\nOnce a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.\n\nParticipants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.",[239,240,241],"Non-Small-Cell Lung","Esophageal Cancer","Cutaneous Melanoma",[243,244,245,246],"Lung cancer","Esophageal cancer","Melanoma","Antibody drug conjugate",{"date":165,"type":35},{"date":249,"type":35},"2026-04-08",{"date":251,"type":21},"2029-07-14",{"name":41,"class":42},15,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":274,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100630545","phase-2-symbiotic-lung-10-a-study-to-learn-about-pf-08634404-alone-or-in-combination-in-early-stage-or-locally-advanced-nsclc-100630545","NCT07489066","Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC","AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Adequate organ function\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his\u002Fher practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.\n* Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.\n* Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.\n\nExclusion Criteria:\n\n* Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.\n* Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n\n  * Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n  * Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":262,"type":21},120,[149],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.\n\nThe study is seeking participants who:\n\n* Are aged 18 years or older\n* Have either:\n\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.\n  * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.\n* Be in good physical condition and have healthy organs based on medical tests.\n* Do not have known actionable changes in DNA\n\nThe study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:\n\n* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.\n* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.\n* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.\n\nAll treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[266,239,267,268,269,270,271,272,273],"Carcinoma","Lung Cancer (NSCLC)","Lung Neoplasms","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Disease","Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer, Non-squamous","Non-small Cell Lung Cancer, Squamous",[275,276,277,278,279,280,281,282,283,284],"early stage non small cell lung cancer","NSCLC","adjuvant NSCLC","locally advanced non small cell lung cancer","resectable NSCLC","unresectable NSCLC","neoadjuvant NSCLC","consolidation NSCLC","squamous NSCLC","non-squamous NSCLC",{"date":165,"type":35},{"date":287,"type":35},"2026-06-30",{"date":289,"type":21},"2031-07-30",{"name":41,"class":42},17,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":309,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},"100629562","phase-2-symbiotic-lung-14-a-study-to-learn-about-the-study-medicine-called-pf08634404-in-combination-with-chemotherapy-in-adult-participants-with-transformed-small-cell-lung-cancer-100629562","NCT07476287","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",{"count":300,"type":21},40,[149],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[304,305,306,268,307,308],"Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[306,304],{"date":165,"type":35},{"date":312,"type":35},"2026-07-02",{"date":314,"type":21},"2031-03-19",{"name":41,"class":42},30,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":330,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},"100625755","phase-1-an-open-label-study-to-evaluate-pf-07994525-in-participants-with-advanced-cancers-100625755","NCT07426757","An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers","AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-07994525 IN PARTICIPANTS WITH ADVANCED MALIGNANCIES","Inclusion Criteria:\n\n* Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent.\n* Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014)\n\nMeasurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n1. Serum M-protein \\>0.5 g\u002FdL by serum protein electrophoresis (SPEP)\n2. Urinary M-protein excretion \\>200 mg\u002F24 hours by urine protein electrophoresis (UPEP)\n3. Serum immunoglobulin Free Light Chain (FLC) ≥10 mg\u002FdL (≥100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65)\n\n   * Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A minimum of 3 prior lines of therapy are required.\n   * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\nExclusion Criteria:\n\n* Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome.\n* Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD).\n* Active or suspected cerebral\u002Fmeningeal disease related to the underlying malignancy.\n* Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), known HIV or AIDS related illness, unless deemed not clinically significant by the investigator (eg, onychomycosis).",{"count":262,"type":21},[55],"This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R\u002FR MM.\n\nThe study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R\u002FR MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R\u002FR MM to further assess safety, PK, PD, and preliminary anti-tumor activity.",[328,329],"Advanced Malignancies","Advanced Cancer",[328,331,329],"Advanced Cancers",{"date":165,"type":35},{"date":334,"type":35},"2026-07-01",{"date":336,"type":21},"2030-07-10",{"name":41,"class":42},19,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":354,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":368},"100625366","phase-1-symbiotic-gu-06-a-study-to-learn-about-pf-08634404-alone-or-in-combination-with-enfortumab-vedotin-in-urothelial-cancer-100625366","NCT07421700","Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer","AN INTERVENTIONAL PHASE 1B\u002F2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER","Inclusion Criteria:\n\n* Age ≥18 years at the time of screening.\n* Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA\u002FmUC).\n* Measurable disease per RECIST v1.1 criteria.\n* ECOG performance status of 0 or 1.\n* Adequate organ function, including hematologic, hepatic, and renal parameters.\n* Willingness to comply with study procedures and provide informed consent.\n* For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following:\n\n* History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy\n* Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Active autoimmune diseases requiring systemic treatment within the past 2 years\n* Participation in another investigational study within 30 days or 5 half-lives of the investigational product.\n* Pregnant or breastfeeding individuals.\n* Inability or unwillingness to comply with study requirements.\n* Study staff or their immediate family members directly involved in the conduct of the study.",{"count":347,"type":21},132,[55,149],"This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA\u002FmUC), meaning the cancer has spread to nearby tissues or other parts of the body.\n\nThe purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer.\n\nTo join the study, participants must:\n\n* Be adults (18 years or older) and\n* Have locally advanced or metastatic urothelial cancer,\n\nThe study has two groups:\n\n* Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone.\n* Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin.\n\nEveryone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable.\n\nBefore starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer.\n\nIf the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.",[351,352,353],"Urothelial Cancer","Advanced\u002FMetastatic Urothelial Cancer","Urothelial Carcinoma",[355,356,357,358,359,360,361],"urothelial cancer","metastatic urothelial cancer","locally advanced urothelial cancer","bladder cancer","urothelial carcinoma","PD-1","VEGF",{"date":165,"type":35},{"date":364,"type":35},"2026-03-11",{"date":366,"type":21},"2028-09-05",{"name":41,"class":42},153,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":385,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100623150","phase-2-symbiotic-gi-16-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-gastroesophageal-cancer-100623150","NCT07392892","Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer","A PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA","Inclusion Criteria:\n\n* Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Evidence of locally advanced or metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* No prior systemic therapy for advanced or metastatic disease.\n* Adequate hepatic, liver, and renal function\n* HER-2 negative status based on local testing\n* PD-L1 positive status based on local testing\n\nExclusion Criteria:\n\n* Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":377,"type":21},840,[149,80],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\nBe 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.\n\nThe treatment will be given in repeated time periods called cycles.",[381,382,383,384],"Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma","Metastatic Gastric Cancer","Gastroesophageal Junction Cancer","Esophageal Adenocarcinoma",[386,387,388],"gastric cancer","gastroesophageal junction cancer","esophageal adenocarcinoma",{"date":165,"type":35},{"date":391,"type":35},"2026-05-14",{"date":393,"type":21},"2032-07-21",{"name":41,"class":42},74,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":415,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100610394","phase-1-symbiotic-gi-13-a-study-to-learn-about-study-medicine-called-pf-08634404-as-a-single-treatment-and-combination-treatment-in-adult-participants-with-a-liver-cancer-called-hepatocellular-carcinoma-that-is-too-advanced-to-be-removed-by-surgery-and-may-have-spread-to-other-parts-of-the-body-100610394","NCT07227012","Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.\n* At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.\n* Adequate hepatic, liver, and renal function\n* No prior systemic therapy for HCC.\n* ECOG performance status 0 or 1\n* Child-Pugh Class A\n\nKey Exclusion Criteria:\n\n* Moderate or severe ascites.\n* History of hepatic encephalopathy.\n* Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Clinically significant risk of hemorrhage or fistula.\n* Participants with any history of another malignancy within 3 years.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.\n* Clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.\n* History of severe bleeding tendency or coagulation dysfunction.\n* History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections.\n* Participants with history of immunodeficiency.",{"count":404,"type":21},138,[55,149],"The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced or metastatic HCC.\n* Is not a candidate for complete surgical or loco-regional therapies.\n* Have not received any whole-body treatment for HCC.\n\nParticipants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.",[408,409,410,411,412,413,414],"Carcinoma, Hepatocellular","Hepatocellular Cancer","Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Liver Neoplasms","Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma",[410,416,412],"Liver cancer",{"date":165,"type":35},{"date":419,"type":35},"2025-12-01",{"date":421,"type":21},"2028-10-17",{"name":41,"class":42},54,{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100610393","phase-2-symbiotic-lung-04-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-extensive-stage-small-cell-lung-cancer-100610393","NCT07226999","Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer","A GLOBAL PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.\n* Treatment-free for at least 6 months since last chemo\u002Fradiotherapy, among those treated (with curative intent) with prior chemo\u002Fradiotherapy for limited-stage SCLC\n* Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula\n* history of another malignancy within 3 years\n* active autoimmune diseases requiring systemic treatment within the past 2 years",{"count":432,"type":21},550,[149,80],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have extensive-stage small cell lung cancer confirmed by lab tests.\n* Have not received chemotherapy or radiation for this type of lung cancer.\n* Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better.\n\nParticipants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.",[436],"Small Cell Lung Cancer (SCLC)",[438,439,440],"small cell lung cancer","extensive stage small cell lung cancer","first-line",{"date":165,"type":35},{"date":443,"type":35},"2025-12-09",{"date":445,"type":21},"2034-03-11",{"name":41,"class":42},83,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":470,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":481},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":456,"type":21},800,[80],"The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[460,461,462,463,464,465,466,467,468,469],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Colorectal Neoplasms",[471,472,440,473,474],"mCRC","metastatic disease","metastatic colorectal cancer","colon cancer",{"date":165,"type":35},{"date":477,"type":35},"2025-12-11",{"date":479,"type":21},"2031-08-01",{"name":41,"class":42},308,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":498,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":507},"100610052","phase-3-symbiotic-lung-01--a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100610052","NCT07222566","Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent\u002Fsequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Measurable disease based on RECIST v1.1 per investigator.\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Expected survival ≥12 weeks\n\nExclusion Criteria:\n\n* Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.\n* Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C 1 cm are permitted.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n* Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Previous systemic anti-tumor therapy including:\n\n  1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n  2. Previous treatment with immunotherapy\n  3. Prior radiotherapy \\> 30 Gy to the lung \\\u003C 6 months of first dose of study intervention\n  4. Palliative local therapy \\\u003C 2 weeks before the first dose of study intervention;\n  5. Non-specific immunomodulatory therapy \\\u003C 2 weeks before the first dose.\n  6. Prior systemic anti-angiogenic therapy\n* Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.\n* Prior and concomitant therapy:\n\n  1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \\\u003C 10 days to the first dose.\n  2. chronic antiplatelet therapy \\\u003C7 days to randomization.\n  3. live or attenuated live vaccine \\\u003C 4 weeks to the first dose.\n  4. current high-dose systemic corticosteroids.\n  5. prohibited concomitant medication(s) \\\u003C 21 days to the first dose.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":490,"type":21},1410,[80],"This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.\n* Is not a candidate for complete surgical resection or curative chemoradiotherapy.\n* Do not have known actionable genomic alterations\n* Be treatment naïve for advanced or metastatic disease\n\nParticipants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.\n\nEach participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:\n\n* Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.\n* Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.\n\nParticipants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.\n\nThe study will include regular visits for:\n\n* Treatment and health checks: while participant continues receiving treatment.\n* Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.",[494,271,495,269,496,497],"Advanced Non-Small Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","Metastatic Non Small Cell Lung Cancer","Lung Cancer",[284,283,499,500],"metastatic (Stage IV) squamous or non-squamous NSCLC","Advanced or Metastatic Non-Small Cell Lung Cancer",{"date":165,"type":35},{"date":503,"type":35},"2026-01-06",{"date":505,"type":21},"2032-08-26",{"name":41,"class":42},440,{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":523,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":531},"100609549","phase-2-a-study-to-learn-about-study-medicine-called-pf-08049820-in-people-with-eczema-100609549","NCT07216027","A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema","A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS","Inclusion Criteria:\n\nParticipants must meet the following criteria:\n\n1. Are 18 to 64 years of age\n2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs\n3. Have moderate to severe AD as defined by the following at screening and baseline visits:\n\n   * Affected body surface area (BSA) greater than or equal to 10% and up to 60%;\n   * Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;\n   * Eczema Area and Severity Index (EASI) greater than or equal to 16;\n\n   AND\n\n   -Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit\n4. Do not have a suitable prescribed medicine for AD.\n5. Body Mass Index (BMI) of 18 to 38 kg\u002Fm2 and a total body weight greater than 48 kg (106 lbs)\n\nExclusion Criteria:\n\nParticipants must not meet the following criteria:\n\n1. Have an infection that requires treatment\n2. Have other skin conditions other than AD\n3. Have severe uncontrolled asthma\n4. Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit","64 Years",{"count":517,"type":21},165,[149],"The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.\n\nThe study is seeking participants who:\n\n1. Are 18 to 64 years of age;\n2. Were confirmed to have AD at least 6 months ago;\n3. Do not have a suitable prescribed medicine for AD;\n4. Are considered by their doctors to have moderate to severe AD.\n\nThe study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.",[521,522],"Atopic Dermatitis","Eczema, Atopic",[524,521],"Eczema",{"date":165,"type":35},{"date":527,"type":35},"2025-11-20",{"date":529,"type":21},"2028-02-02",{"name":41,"class":42},20,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":560},"100608797","phase-1-a-study-to-learn-about-the-study-medicine-pf-08052667-in-people-with-bladder-cancer-100608797","NCT07206225","A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER","INCLUSION CRITERIA:\n\n1. 18 years of age or older (or the minimum age of consent per local regulations)\n2. Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1\u002FTa papillary disease. Note: High-grade T1\u002FTa papillary disease, in the absence of CIS, may be eligible for certain cohorts in Part 2 and 3\n3. BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy.\n4. Have refused or are ineligible or not appropriate for radical cystectomy\n5. Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment\n6. ECOG PS 0 or 1\n\nEXCLUSION CRITERIA:\n\n1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed\n2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol\n3. Participants with active, uncontrolled infection as specified in the protocol",{"count":540,"type":21},294,[55],"The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and\u002For a medicine called sasanlimab.\n\nThis study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them.\n\nThe study has three parts:\n\n* Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments.\n* Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and\u002For sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments.\n* Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and\u002For sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments.\n\nAll participants will receive the study drug PF-08052667. Only participants in Part 2 and Part 3 of the study will also receive BCG and\u002For sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.\n\nFor all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor.",[544],"Non-muscle Invasive Bladder Cancer",[546,547,548,549,550,551,552,553],"NMIBC","Non-Muscle Invasive Bladder Cancer","Bladder Cancer","Bladder Tumors","Bladder Neoplasms","Malignant Tumor of Urinary Bladder","Urinary Bladder Cancer","Cancer of Bladder",{"date":165,"type":35},{"date":556,"type":35},"2025-11-06",{"date":558,"type":21},"2033-01-28",{"name":41,"class":42},68,{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":576,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":584},"100604035","phase-3-a-study-to-learn-about-the-study-medicine-called-pf-08046054sgn-pdl1v-versus-docetaxel-in-adult-participants-with-previously-treated-programmed-cell-death-ligand-1-pd-l1-positive-non-small-cell-lung-cancer-nsclc-100604035","NCT07144280","A Study to Learn About the Study Medicine Called PF-08046054\u002FSGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054\u002FSGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria\n\n* Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.\n* PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.\n* Participants who have NSCLC with known AGAs are permitted.\n* Able to provide any of the following tumor tissues for biomarker analysis:\n\n  * Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or\n  * De novo biopsy from a tumor lesion, if medically feasible.\n* Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:\n\nParticipants with no known AGAs must fulfill 1 of the following conditions:\n\n* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).\n* Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.\n\nParticipants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:\n\n* Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant\n* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.\n* May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \\[OS\\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n* Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and\u002For radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:\n\n  * The participant is on a stable dose of ≤10 mg\u002Fday of prednisone or equivalent for at least \\>14 days prior to randomization (if requiring steroid treatment).\n  * No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and\u002For surgery.\n  * Time since CNS-directed treatment is ≥28 days prior to randomization.\n* Participants with a history of leptomeningeal metastasis are excluded.\n* Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.\n* Previous receipt of an MMAE-containing agent or prior docetaxel.\n\nThere are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.",{"count":569,"type":21},680,[80],"The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation.\n\nParticipants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.",[573,574,575],"Non-small Cell Carcinoma","Non-Small Cell Lung Cancer Metastatic","Non-Small Cell Lung Carcinoma",[577,276],"Non-small cell lung cancer NSCLC",{"date":165,"type":35},{"date":580,"type":35},"2025-09-29",{"date":582,"type":21},"2032-03-10",{"name":41,"class":42},425,{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":179,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":617},"100589303","phase-4-ocular-assessments-in-patients-treated-with-tivdak-in-recurrent-or-metastatic-cervical-cancer-100589303","NCT06952660","Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer","A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER","Inclusion criteria:\n\n1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy\n2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information\n3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate\n4. Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site\n5. Must agree to use effective contraception according to the US Prescribing Information\n\nExclusion criteria:\n\n1. Active ocular disease at baseline per investigator assessment\n2. Previous treatment with Tivdak\n3. Previous administration of an investigational drug within 30 days\n4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may, in the investigator'",{"count":593,"type":21},100,[24],"TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.\n\n* This study is seeking for participants who: Are willing to take all the required eye tests\n* Have not received TIVDAK before\n* Do not have any active eye issues.\n\nParticipants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:\n\n* before starting the treatment,\n* before each of the first 9 infusions\n* then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.",[597],"Cervical Cancer",[599,600,601,463,602,603,604,605,606,607,608,609,610],"Uterine Neoplasms","Genital Neoplasms","Female Urogenital Neoplasms","Neoplasms Uterine","Cervical Diseases","Uterine Diseases","Genital Diseases, Female","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Genital Diseases Uterine Cervical Neoplasms,","Tisotumab vedotin",{"date":165,"type":35},{"date":613,"type":35},"2025-05-07",{"date":615,"type":21},"2028-12-13",{"name":41,"class":42},129,{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":627,"conditions":628,"keywords":631,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":198},"100585195","real-world-efficiency-of-abrocitinib-treatment-at-patients-with-moderate-to-severe-atopic-dermatitis-who-had-inadequate-response-to-previous-biologic-therapies-100585195","NCT06899204","Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.","A Prospective, Multi-center Observational Study Characterizing Clinical Outcomes of Patients Receiving Abrocitinib for Moderate-to-severe Atopic Dermatitis Who Had an Inadequate Response (or Intolerance) to ≤2 Previous Biologic Therapies Approved for Moderate-to-severe Atopic Dermatitis","This NI study will enroll 150 patients from approximately 15 sites across the US. The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib and satisfy the inclusion and exclusion criteria. Patients who had inadequate response or intolerance to previous ≤2 biologic therapies will be included in this study as there is a lack of effectiveness data for abrocitinib in these patients. As this will be an observational study, there will be no sampling and all patients that meet the inclusion and exclusion criteria will be recruited consequently. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Regarding the inclusion and exclusion criteria, in the real-world setting recruitment may be slower than expected, thus depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study.\n\n9.2.1. Inclusion Criteria\n\nPatients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Participants who have chronic AD that has been present for ≥1 year before screening.\n2. Male and female patients aged \\>12 years at baseline.\n3. Patients with diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist, who are prescribed abrocitinib for use in accordance with the product label (USPI) and independently of the decision to enroll the patient in this study\n4. Patients who have inadequate responses or are intolerant to ≤2 previous biologic therapy approved for M2S AD. (Patients shall have had an inadequate response and\u002For intolerance to at least one, but no more than 2 biologic therapies approved for moderate-to-severe AD)\n5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the study, the adolescent (depending on local institutional review board\u002Findependent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.\n6. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.\n\n9.2.2. Exclusion Criteria\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Patients, that currently have active forms of other inflammatory skin diseases, other than AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.\n2. Patients previously treated with abrocitinib or other oral\u002Fsystemic JAK inhibitors\n3. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.\n4. Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.",{"count":626,"type":21},150,"This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States.\n\nThe aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.",[521,629,630],"Atopic Dermatitis, Unspecified","Dermatitis, Atopic",[632],"Real world efficacy",{"date":165,"type":35},{"date":635,"type":35},"2026-04-24",{"date":637,"type":21},"2027-02-15",{"name":41,"class":42},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":646,"maxAge":647,"enrollmentInfo":648,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":226},"100578129","phase-3-a-long-term-study-of-the-medicine-called-abrocitinib-in-children-aged-2-years-and-older-with-moderate-to-severe-eczema-100578129","NCT06807281","A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema","A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria for the Extension Cohort:\n\n1\\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \\\u003C12 years old).\n\n• No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.\n\nInclusion Criteria for the De Novo Cohort:\n\nAge\n\n1. Children aged 6 to \\\u003C12 years at the time of informed consent\u002Fassent.\n\n   • No contraception methods are required for male participants.\n\n   Disease Characteristics:\n2. Participants who meet all of the following AD criteria:\n\n   * A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and\n   * A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and\n   * Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy.\n\n   Other Inclusion Criteria:\n3. Body weight ≥15 kg\n\nExclusion Criteria for the Extension Cohort:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n\n   Prior\u002FConcomitant Therapy:\n2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.\n3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.\n\n   Diagnostic Assessments:\n4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.\n5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.\n\nExclusion Criteria for the De Novo Cohort\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n2. Have any of the following medical conditions:\n\n   * Infections:\n\n     * Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (baseline) or have superficial skin infections within 1 week of Day 1.\n     * History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.\n     * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.\n     * Infection with HIV, hepatitis B, and\u002For hepatitis C\n     * Evidence of active TB or inadequately treated latent TB.\n   * Skin Conditions:\n\n     \\- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.\n   * Other Conditions:\n\n     * Documented history of skeletal dysplasia.\n     * Documented history of retinal detachment.\n     * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.\n     * Prior history of leukemia, lymphoma, sarcoma or any other malignancy.\n     * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.\n     * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.\n\n   Prior\u002FConcomitant Therapy:\n3. Prior treatment with a systemic JAK inhibitor for AD.\n4. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.\n5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.\n\n   Diagnostic Assessments:\n7. Hepatic and\u002For renal and\u002For hematological abnormalities defined as:\n\n   * AST \\>2 x ULN\n   * Hemoglobin \\\u003C10 g\u002FdL\n   * ALT \\>2 x ULN\n   * ANC \\\u003C1000\u002Fmm3\n   * Total bilirubin ≥1.5 x ULN\n   * ALC \\\u003C500\u002Fmm3\n   * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2\n   * Platelets \\\u003C150,000 \u002Fmm3\n\n   Other Exclusion Criteria:\n8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","2 Years","11 Years",{"count":649,"type":21},500,[80],"This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.",[521],[654,655],"eczema","atopic dermatitis",{"date":165,"type":35},{"date":658,"type":35},"2025-12-02",{"date":660,"type":21},"2032-02-22",{"name":41,"class":42},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":669,"maxAge":647,"enrollmentInfo":670,"targetDuration":4,"studyType":22,"phases":671,"briefSummary":672,"conditions":673,"keywords":674,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":682},"100578128","phase-3-a-study-of-the-medicine-called-abrocitinib-in-children-6-to-less-than-12-years-of-age-with-moderate-to-severe-eczema-100578128","NCT06807268","A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema","A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS","Inclusion Criteria Children aged 6 to \\\u003C12 years at the time of informed consent\u002Fassent.\n\n• No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.\n\nDisease Characteristics:\n\nParticipants who meet all of the following AD criteria:\n\n* A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria\\[19\\]; and\n* A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and\n* Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy\n\nOther Inclusion Criteria:\n\nBody weight ≥15 kg\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\nAny medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\nIf the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n\nHave any of the following medical conditions:\n\n* Infections:\n\n  * Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day 1.\n  * History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.\n  * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.\n  * Infection with HIV, hepatitis B, and\u002For hepatitis C\n  * Evidence of active TB or inadequately treated latent TB.\n* Skin Conditions:\n\n  \\- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.\n* Other Conditions:\n\n  * Documented history of skeletal dysplasia.\n  * Documented history of retinal detachment.\n  * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.\n  * Prior history of leukemia, lymphoma, sarcoma or any other malignancy.\n  * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.\n  * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.\n\nPrior\u002FConcomitant Therapy:\n\nPrior treatment with a systemic JAK inhibitor for AD. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.\n\nConcomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.\n\nPrior\u002FConcurrent Clinical Study Experience:\n\nPrevious administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.","6 Years",{"count":626,"type":21},[80],"This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \\\u003C12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.",[524],[675],"Dermatitis",{"date":165,"type":35},{"date":678,"type":35},"2025-07-24",{"date":680,"type":21},"2027-05-02",{"name":41,"class":42},43,""]