[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"penile-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:penile-squamous-cell-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100609637","phase-1-a-study-evaluating-the-safety-efficacy-and-pharmacokinetics-pk-of-evolve104-in-participants-with-advanced-urothelial-and-squamous-cell-carcinomas-100609637",false,"NCT07217171","A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas","A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas","Key Inclusion Criteria:\n\nParticipants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma.\n\n1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.\n2. The cancer must be measurable by CT scan or MRI.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.\n4. Anticipated life expectancy of at least 3 months.\n5. Adequate organ function, as indicated by standard blood tests.\n6. Able to provide a fresh or archival tumor biopsy.\n7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile.\n\nKey Exclusion Criteria:\n\n1. The participant is a candidate for treatment with a targeted agent known to provide a benefit.\n2. Persistent significant toxicities from prior anticancer therapy.\n3. Brain metastases unless previously treated and stable.\n4. Prior severe or life-threatening immunologic reactions to previous therapies.\n5. Significant medical conditions, including but not limited to:\n\n   * History of clinically significant cardiac disease\n   * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.\n   * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.\n   * History of cirrhosis or significant portal hypertension.\n   * Uncontrolled or significant infection.\n   * History of certain other cancers in the past 3 years.\n   * History of arterial thrombosis, stroke and transient ischemic attack within 6 months.\n   * Active or uncontrolled HIV, HBV or HCV infection.\n   * Autoimmune or other condition requiring chronic systemic immunosuppression.","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.",[26,27,28,29,30,31,32,33,34,35,36],"Bladder Cancer","Squamous Cell Carcinoma of the Lung","Esophageal Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Cutaneous Squamous Cell Cancer","Penile Squamous Cell Carcinoma","Anal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Vaginal Squamous Cell Carcinoma","Urethral Squamous Cell Carcinoma",[38,39,40,41,42,43,44,45,46],"bladder","lung","esophagus","tongue","penile","anal","vulvar","cervical","vaginal","RECRUITING","2026-07-01",{"date":50,"type":51},"2026-07-02","ACTUAL",{"date":53,"type":51},"2025-11-13",{"date":55,"type":20},"2031-01-29",{"name":57,"class":58},"EvolveImmune United, Inc","INDUSTRY",12,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":5},"100543287","phase-2-carboplatinpaclitaxel--pembrolizumab-for-locoregionally-advanced-penile-cancer-100543287","NCT06353906","Carboplatin\u002FPaclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer","A Phase 2 Clinical Study to Assess Efficacy of Induction Carboplatin\u002FPaclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer: PRIAM","PRIAM","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n2. Histologically confirmed diagnosis of squamous cell carcinoma of the penis.\n3. Patients have one of the following disease stages:\n\n   * cTxN2-3 or\n   * cTxN1 in case of central nodal necrosis and\u002For an irregular nodal border, or node \\>3cm, or\n   * Inguinal or pelvic lymph node recurrence that is potentially resectable. Any of the disease stages above, in combination with oligometastatic disease with a maximum of 2 distant metastases is allowed, as long as these metastases can be treated by resection or radiotherapy. This should be established in the multidisciplinary tumor board before enrolment.\n4. Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n5. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention.\n7. Have adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 10e9 \u002FL, platelets ≥100 10e9\u002FL; hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL; creatinine ≤1.5 × ULN OR GFR\\>30 ml\u002Fmin as per Cockcroft-Gault formula in patients with creatinine levels \\> 1.5x institutional ULN; total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; International normalized ratio (INR), prothrombin time (PT) OR activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Specimens must be collected within 14 days prior to the start of study intervention.\n\nExclusion Criteria:\n\n1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n2. Has received prior systemic anti-cancer therapy including investigational agents, or an investigational device, within 4 weeks prior to registration.\n3. Has received prior radiotherapy within 4 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.\n4. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n6. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n   Exceptions: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n7. Has known active or treated CNS metastases and\u002For carcinomatous meningitis.\n8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n9. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid). Patients with vitiligo, psoriasis or other mild skin disease can still be included.\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n11. Has an active infection requiring systemic therapy.\n12. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n13. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and\u002For Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Hepatitis B and C screening tests are not required unless a patient has a known history of HBV or HCV infection. Participants must have completed curative anti-viral therapy at least 6 months prior to randomization.\n14. Has not adequately recovered from major surgery or has ongoing surgical complications.\n15. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for the disease under study.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is expecting to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n19. Has had an allogenic tissue\u002Fsolid organ transplant","MALE",{"count":70,"type":20},27,[72],"PHASE2","This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis",[75,76,77,78,31,79],"Urologic Neoplasms","Urogenital Neoplasms","Male Urogenital Diseases","Penile Cancer","Locally Advanced Penile Carcinoma","2025-12-05",{"date":82,"type":51},"2025-12-08",{"date":84,"type":51},"2024-08-13",{"date":86,"type":20},"2028-01-14",{"name":88,"class":89},"The Netherlands Cancer Institute","OTHER"]