[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-cutaneous-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-cutaneous-squamous-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100647047","d-tect-pretreatment-d-dimers-and-disease-control-in-advanced-cscc-treated-with-cemiplimab-100647047",false,"NCT07684066","D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab","D-TECT: Prospective Multicenter Evaluation of Pretreatment D-dimer Levels as a Predictor of Disease Control in Advanced Cutaneous Squamous Cell Carcinoma Treated With Cemiplimab","D-TECT","Inclusion Criteria:\n\n* Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma\n* Planned initiation of systemic treatment with cemiplimab as part of routine clinical care\n* Pretreatment D-dimer measurement performed within 7 days before initiation of cemiplimab treatment up to the day of first administration before infusion\n* Age 18 years or older at the time of consent\n* ECOG performance status 0 to 2\n* Written informed consent for study participation and pseudonymized collection and analysis of clinical and laboratory data\n\nExclusion Criteria:\n\n* Prior treatment with immune checkpoint inhibitors in curative or palliative intent for cutaneous squamous cell carcinoma\n* Concurrent second malignancy requiring systemic treatment, such as chemotherapy, immunotherapy, or targeted therapy\n* Clinically unstable comorbidity, including NYHA class III-IV heart failure or active systemic infection\n* Acute symptomatic thrombosis or pulmonary embolism within 4 weeks before the pretreatment D-dimer measurement\n* Incidental asymptomatic thromboembolic events detected during clinical diagnostic work-up or following an elevated D-dimer result are not exclusion criteria and will be documented\n* Physician-estimated life expectancy of less than 3 months or severe non-tumor-related comorbidity likely to preclude assessment of the clinical course within the first 6 months\n* Lack of capacity to consent or legal guardianship without valid legal representation","ALL","18 Years",{"count":20,"type":21},116,"ESTIMATED","OBSERVATIONAL","D-TECT is a prospective, multicenter, non-interventional observational study investigating whether pretreatment D-dimer levels predict disease control in patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care.\n\nD-dimers are routinely available laboratory markers related to activation of the coagulation system. Previous single-center data suggest that elevated pretreatment D-dimer levels may be associated with poorer disease control under cemiplimab. In D-TECT, a single pretreatment D-dimer value and prospectively collected routine clinical follow-up data will be analyzed to validate this association in a multicenter real-world setting. No study-specific treatment decisions, imaging procedures, or additional blood draws are mandated by the study.",[25,26,27],"Cutaneous Squamous Cell Carcinoma (CSCC)","Advanced Cutaneous Squamous Cell Carcinoma","Metastatic Cutaneous Squamous Cell Carcinoma",[29,30,31,32,33,34,35,36,37,38],"CSCC","Cutaneous Squamous Cell Carcinoma","D-Dimer","Cemiplimab","PD-1 inhibitor","immunotherapy","biomarker","disease control","coagulation","real-word evidence","NOT_YET_RECRUITING","2026-07-21",{"date":42,"type":43},"2026-07-22","ACTUAL",{"date":45,"type":21},"2026-08-01",{"date":47,"type":21},"2030-03-31",{"name":49,"class":50},"Universitätsklinikum Hamburg-Eppendorf","OTHER",15,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100647856","phase-2-cemiplimab-for-kidney-transplant-recipients-with-advanced-cutaneous-squamous-cell-carcinoma-100647856","NCT07715734","Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma","A Phase 2 Study of Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC-2)","CONTRAC-2","Inclusion Criteria:\n\n* Histologically confirmed locoregionally advanced and unresectable or recurrent\u002Fmetastatic cutaneous squamous cell carcinoma (CSCC). Definitions that encompass unresectable disease include any of the following, after discussion at the multidisciplinary meeting:\n\n  * Anatomically unresectable disease to include carotid artery encasement; invasion into the skull base, cavernous sinus, sagittal sinus; pre-vertebral fascia\u002Fvertebral body\u002Fvertebral artery; disseminated distant metastatic disease\n  * Functionally unresectable disease resulting in the loss of sight, oral competency\u002Fspeech\u002Fswallowing, or limb\n  * Biologically unresectable disease to include satellitosis, in-transit\u002Fdermal metastasis, or disease which has failed 2 or more prior surgeries (by an experienced CSCC surgeon) or failed curative intent radiation therapy\n* Measurable disease per RECIST 1.1.\n* Received a kidney transplant. Must have a functioning allograft, be at least 6 months from last allograft transplantation, and have had no evidence of biopsy-proven allograft rejection (Banff 1A or above, requiring treatment) at any time. In order to be considered a functioning allograft, the following criteria must be met:\n\n  * Estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin (using the CKD-EPI equation either by Cr or Cystatin C based measurement) (Inker LA et al, 2021)\n  * Baseline proteinuria \\\u003C 0.5 g\u002Fday (by spot urine protein-creatinine ratio or 24-hr urine collection, if available)\n  * Not receiving antiproliferative immunosuppressive medications. If patients are on antiproliferative immunosuppressive medications, they must be discontinued for at least 7 days before initiation of C1D1 (i.e. at the screening visit and\u002For during the lead-in period)\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Leukocytes ≥ 2.2 K\u002Fcumm\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 90 K\u002Fcumm\n  * Total bilirubin within normal institutional limits (except in cases where Gilbert syndrome is known or suspected, where total bilirubin should be \\\u003C 3 mg\u002FdL)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN\n* The effects of cemiplimab on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 4 months after last dose of cemiplimab.\n* Able to switch immunosuppression regimen to sirolimus and prednisone if not already receiving sirolimus and prednisone as SOC.\n* Able to understand and willing to sign an IRB approved written informed consent document and willing and able to comply with clinic visits and study-related procedures. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received chemotherapy or radiotherapy within 2 weeks prior to C1D1. Note: prior cetuximab exposure is permitted, but it must have been discontinued at least 2 weeks prior to the start of cemiplimab.\n* Received prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CLTA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (including chimeric antigen receptor \\[CAR\\] T-cell therapies).\n\nNote: prior topical or intralesional immunotherapies (e.g., imiquimod, talimogene laherparepvec) are permitted.\n\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial\n* Currently receiving any other investigational agents.\n* Unable to swallow pills.\n* Currently receiving any medications or substances that are strong inhibitors or inducers of CYP3A4.\n* Receipt of a live vaccine within 28 days of C1D1.\n* Receipt of COVID-19 vaccination within 7 days of C1D1 or for which the planned COVID-19 vaccinations would not be completed 7 days prior to C1D1.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression and if they are at least 4 weeks out from treatment. They must also be asymptomatic and on stable doses of anti-epileptic drugs (AEDs) and oral corticosteroids at the time of enrollment\n* A history of allergic reactions attributed to or known hypersensitivity to cemiplimab or any of its components or other agents used in the study.\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. Note: the following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded.\n* Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\> 10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 7 days prior to C1D1. Patients who require a brief course of steroids (up to 2 days in the week before C1D1) or physiologic replacement are not excluded.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring hospitalization or treatment with IV anti-infectives within 14 days prior to C1D1; NYHA heart failure classifications of Class II, III, or IV; myocardial infarction or acute coronary syndrome within 12 months prior to C1D1; unstable angina pectoris; cardiac arrhythmia; transient ischemic attack or stroke within 12 months prior to C1D1.\n* Known non-infectious pneumonitis or any history of interstitial lung disease.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.\n* Uncontrolled infection with HIV, hepatitis B or C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent).\n\n  * Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count \\> 350 either spontaneously or on a stable antiviral regiment are eligible. For these participants, monitoring will be performed as per local standards.\n  * Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of cemiplimab.\n  * Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: if serum HBV DNA is above the limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.\n  * Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are eligible.",{"count":61,"type":21},22,"INTERVENTIONAL",[64],"PHASE2","This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.",[67,25,26,68],"Kidney Transplant Recipient","Kidney Transplant",[70,71,72],"Cutaneous squamous cell carcinoma","Advanced cancer","Kidney transplant","2026-07-11",{"date":75,"type":43},"2026-07-20",{"date":77,"type":21},"2026-09-30",{"date":79,"type":21},"2031-03-31",{"name":81,"class":50},"Washington University School of Medicine",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":62,"phases":92,"briefSummary":94,"conditions":95,"keywords":102,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100509238","phase-1-a-phase-ibii-study-of-an-anti-her3-antibody-hmbd-001-with-cetuximab---docetaxel-in-advanced-squamous-cell-cancers-100509238","NCT05910827","A Phase Ib\u002FII Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +\u002F- Docetaxel in Advanced Squamous Cell Cancers","A Phase Ib\u002FII Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Ability to understand and be willing to sign an informed consent form\n\n  * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \\> 18 years of age)\n  * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1\n  * Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable\n  * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,\n  * Have an estimated life expectancy of at least 3 months\n  * Participants must be willing to provide a fresh tumor biopsy sample\n  * Have adequate organ function\n  * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal\n  * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion\n\nExclusion Criteria:\n\n* Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C\n\n  * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and\u002For KRAS G12C mutation\n  * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \\>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and\u002For impact the study results e.g., alopecia\n  * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment\n  * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline\n  * Evidence of abnormal cardiac function\n  * History of uncontrolled allergic reactions and\u002For known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into\n  * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n  * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment\n  * Known Human Immunodeficiency Virus (HIV) infection\n  * Active hepatitis B or hepatitis C infection\n  * Pregnant or breast feeding\n  * COVID 19 infection within 3 months prior to the first dose of the study drug\n  * COVID 19 vaccination within 14 days prior to the first dose of the study drug\n  * Treatment with strong inhibitors or inducers of CYP3A4",{"count":91,"type":21},398,[93,64],"PHASE1","This is a Phase Ib\u002FII multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers",[96,97,98,99,26,100,101],"Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Esophageal Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Nasopharyngeal Cancinoma (NPC)","Squamous Cell Carcinoma",[103,104,105,106,107,108,109,110,111,112,113,29,114,115,116,117],"NSCLC","Non-small Cell Lung Cancer","sqNSCLC","Lung","Squamous","HER3","ErbB3","Docetaxel","Cetuximab","cervical squamous cell carcinoma","HNSCC","ESCC","advanced squamous cell cancer","NPC","SCC","RECRUITING","2026-05-24",{"date":121,"type":43},"2026-05-27",{"date":123,"type":43},"2024-02-05",{"date":125,"type":21},"2027-12",{"name":127,"class":128},"Hummingbird Bioscience","INDUSTRY",20]