[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-tract-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-tract-neoplasm":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100651303","phase-2-combination-bevacizumab-and-prgn-2012-in-adults-with-recurrent-respiratory-papillomatosis-rrp-100651303",false,"NCT07756840","Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)","A Phase II Study of Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)","* INCLUSION CRITERIA:\n* Histological or cytological diagnosis of RRP confirmed by pathology report. Note: If there is no documentation or archival sample, a biopsy will be done to confirm the diagnosis.\n* Age \\>= 18 years old.\n* A history of 2 or more surgeries or use of IV bevacizumab in order to control laryngeal and\u002For tracheal RRP within 12 months prior to the study treatment initiation.\n* Previous treatment with PRGN-2012 (zopapogene imadenovec \\[Papzimeos\\]).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have an adequate organ and marrow function as defined below:\n\n  * White blood cells (WBC) \\>2,000\u002FmcL\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmcL\n  * Hemoglobin \\> 9.0 g\u002FdL\n  * Platelets \\>= 100,000\u002FmcL\n  * Total bilirubin \\\u003C= 1.5 mg\u002FdL. Note: participants with Gilbert s Syndrome must have a total bilirubin \\\u003C 3.0 mg\u002FdL\n  * Aspartate aminotransferase (AST) \\\u003C= 2.5 X institutional upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 X institutional ULN\n  * Creatinine within normal institutional limits OR Creatinine Clearance (CrCl) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal (calculated using the Cockcroft-Gault formula).\n  * Prothrombin time (PT) \u002F International normalized ratio (INR) and Partial thromboplastin time (PTT) \\\u003C= 1 X institutional ULN. In participants on anticoagulation, coagulation tests should be within a therapeutic range.\n  * Urinalysis Urine dipstick \\\u003C 2+ proteinuria. Participants with \\>= 2+ proteinuria on dipstick urinalysis should undergo a 24- hour urine collection and must demonstrate \\\u003C= 1g of protein in 24 hours to be eligible\n* Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of treatment and up to 6 months after completion of the study treatment.\n\nMen must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of treatment and up to 4 months after the last dose of study drugs. We also recommend men with partners of childbearing potential ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men must not freeze or donate sperm within the same period.\n\n* Women who are breastfeeding or plan to breastfeed must agree to discontinue breastfeeding from study treatment initiation.\n* Ability of participant to understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of significant cardiovascular disease or thromboembolic event: cerebral vascular accident\u002Fstroke, myocardial infarction, unstable angina, congestive heart failure (\\>= New York Heart Association Classification Class II) occurring within 12 months prior to the study treatment initiation\n* Serious cardiac arrhythmia requiring medication as assessed by electrocardiogram (EKG) at screening.\n* Any investigational agents within 4 weeks prior to the study treatment initiation.\n* Systemic medical RRP therapy within 4 weeks or 3 half-lives, whichever is longer prior to the study treatment initiation.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the study treatment initiation. Note: Inhaled, topical intranasal or intraocular steroids, and adrenal replacement doses \\\u003C10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* History of abdominal fistula or gastrointestinal perforation within 12 months prior to the study treatment initiation.\n* Major surgery within 4 weeks prior to the study treatment initiation. Note: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges).\n* Non-healing wounds, active ulcer, or untreated bone fracture.\n* History of hemoptysis (\\>2.5 mL of bright red blood per episode) within 1 month prior to the study treatment initiation.\n* History of serious hemorrhage (CTCAE Grade 4) within 12 months prior to the study treatment initiation.\n* Evidence of bleeding diathesis or significant coagulopathy (with or without current therapeutic anticoagulation).\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the study treatment initiation.\n* Inadequately controlled hypertension (defined as systolic blood pressure (BP) \\>150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Note: an average of 3 BP readings on 2 sessions will be used to measure blood pressure if the initial reading indicates inadequately controlled hypertension. Anti-hypertensive therapy to achieve blood pressures below these parameters is allowed.\n* Prior history of hypertensive crisis or hypertensive encephalopathy.\n* Persisting toxicity related to prior therapy of Grade \\>1 per CTCAE. Note: Alopecia, sensory neuropathy Grade \\\u003C= 2 are acceptable.\n* Known, active alcohol or drug abuse.\n* History of allergy to study drug components.\n* History of \\>= Grade 3 per CTCAE infusion-related reaction to bevacizumab or PRGN-2012.\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.\n* Uncontrolled symptomatic, intercurrent illness evaluated by medical history, physical exam, and labs, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study, or that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nRecurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths called papillomas to grow in the airway, most often in the voice box, windpipe, or lungs. These growths can make it hard to speak or breathe. Surgery can remove the papillomas, but they often come back. In some cases, they can become cancerous.\n\nObjective:\n\nThis study istesting whether two treatments used together (PRGN-2012, a vaccine-based treatment and bevacizumab, a drug that affects blood vessel growth) can help control RRP and reduce the chance that papillomas will grow back.\n\nEligibility:\n\nAdults aged 18 years and older may be able to join the study if they have RRP and meet certain treatment history requirements. This may include people who have previously received PRGN-2012 or bevacizumab, or people who have needed more than 2 surgeries to remove papillomas.\n\nDesign:\n\nBefore starting treatment, participants will have screening tests to make sure the study is safe for them. These tests may include a physical exam with blood and urine tests, heart function testing, imaging scans, and an endoscopy. During an endoscopy, a thin, flexible tube with a small camera will look at the inside of the nose, throat, voice box, and upper windpipe.\n\nParticipants will receive study treatment during 7 clinic visits over about 6 months. Bevacizumab is given through a vein amd PRGEN-2012 is given as an injection under the skin of the arm or leg. Participants may receive 1 or both drugs at each visit.\n\nAfter completing treatmen, participants will return for 4 follow-up visits over 1 year. These visits may include repeat imaging, blood and urine tests, and other exams. After that, the study team will contact participantsby phone or email every 3 months for 2 years.\n\nIf their RRP gets worse during the follow-up period, they may be able to receive a second course of treatment using the same schedule....",[27,28,29,30,31,32],"Respiratory Recurrent Papillomatosis (RRP)","Human Papillomavirus (HPV)","Papillomavirus Infection","Laryngeal Diseases","Tracheal Diseases","Respiratory Tract Neoplasm",[34,35,36,37],"HPV Vaccine","Gardasil","Papzimeos (zopapogene imadenovec-drba)","Bevacizumab (Avastin)","NOT_YET_RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":21},"2026-08-26",{"date":46,"type":21},"2030-07-01",{"name":48,"class":49},"National Cancer Institute (NCI)","NIH",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100611992","phase-2-study-for-evaluating-the-safety-and-feasibility-of-fecal-microbiota-transplant-in-stage-ii-iii-nsclc-patients-using-ici-responders-as-donors-migrant-100611992","NCT07247786","Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)","Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.","MIGRANT","Inclusion Criteria:\n\n* Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIA, IIB, IIIA or IIIB (only T3N2) disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)\n* PET scan and brain CT or MRI at baseline to confirm the absence of distant disease\n* ECOG (Performance status) 0-1\n* Adequate hematologic and organ function.\n* All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention\n* Adequate lung function: Forced Espiratoy Volumen in 1 second (FEV1) \\>50% of normal volume and Difusion Capacity of the Lungs for Carbon Monoxide (DLCO) \\>40% of normal value\n* Patients aged ≥ 18 years at the time of study entry\n* Body weight \\> 30Kg (for durvalumab monotherapy)\n* PDL1 analyzed (value in %)\n* For female patients of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective forms of contraception that results in a low failure rate (\\\u003C 1% per year) when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment.\n* For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment.\n* Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. The same rules are valid for male patients involved in this clinical study if they have a partner of childbirth potential. Male patients must always use a condom.\n* Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.\n* Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Presence of at least one measurable lesion by CT-SCAN, as defined by RECIST v1.1.\n* Patients with a life expectancy ≥12 weeks.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n\nExclusion Criteria:\n\n* Patients with known sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene or any variety of alterations of ALK oncogene.\n* Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.\n* Weight loss \\>10% within the previous 3 months.\n* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.\n* Patients with other active malignancy requiring concurrent intervention and\u002For concurrent treatment with other investigational drugs or anti-cancer therapy\n* History of active primary immunodeficiency\n* History of another primary malignancy.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.\n* Pleural or pericardial effusion.\n* Patients who have experienced untreated and\u002For uncontrolled cardiovascular conditions and\u002For have symptomatic cardiac dysfunction.\n* Positive test for HIV.\n* Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.\n* Patients with history of allergy to study drug components\u002Fexcipients.\n* Active tuberculosis.\n* Severe infections within 4 weeks prior to be included in the study.\n* Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures.\n* Treatment with any other investigational agent with therapeutic intent within 28 days prior to initiation of study treatment.\n* Patients with uncontrolled comorbidities that may affect the clinical trial compliance.\n* Women who are pregnant or in the breastfeeding period or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.\n* Patients must be informed that they are not allowed to donate blood during the treatment period of this clinical trial.\n* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n* Receipt of a live attenuated vaccine within 30 days prior to the first dose of investigational product (IP).\n* Concurrent enrollment in another clinical study, except in cases where the study is observational (non-interventional) or the patient is in the follow-up phase of a previous interventional study.",{"count":60,"type":21},68,[24],"This is a randomized, phase II, multi-centre clinical trial.\n\nSample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)\n\nPopulation: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer\n\nIn the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .\n\nIn the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.\n\nAfter neoadjuvant\u002Finduction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.\n\nThe primary objective is to evaluate the pathological Complete Response (pCR) rate.\n\nThe total trial duration will be 6.5 years approximately.",[64,32],"Non Small Cell Lung Cancer",[66,67,68,69,70,71],"Non small cell lung cancer","Fecal microbiota transplant","Inmune checkpoint inhibitor responder","Neoadjuvant treatment","Adjuvant treatment","Durvalumab","2026-04-29",{"date":74,"type":42},"2026-05-05",{"date":76,"type":21},"2026-09-15",{"date":78,"type":21},"2031-12-30",{"name":80,"class":81},"Fundación GECP","OTHER",20]