[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"penile-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:penile-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,45,132,196,233,254,282,304,324,351,378,416,436,457,480,507,529,546],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100632845","phase-2-egfr-adc-becotatug-vedotin-combined-with-pd-1-inhibitor-pucotenlimab-in-neoadjuvant-treatment-of-advanced-penile-cancer-100632845",false,"NCT07518979","EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer","Neoadjuvant Therapy With EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) for Penile Squamous Cell Carcinoma With Penile Preservation Difficulty or Regional Lymph Node Metastasis: A Single-Arm, Phase II Clinical Trial","MH-Penile-002","1. Inclusion Criteria （1）Histologically\u002Fcytologically confirmed penile squamous cell carcinoma (PSCC); （2）EGFR expression (IHC 1+, 2+, or 3+) confirmed by local pathology department; （3）No prior systemic therapy, or recurrence ≥6 months after adjuvant therapy for radical resection; （4）Male, aged ≥18 years; （5）Cytologically positive or clinically palpable inguinal lymphadenopathy, fixed mass, radiologically diagnosed pelvic lymph node metastasis, or penile preservation difficulty (unable to perform surgery with negative margin and functional penile stump preservation); （6）At least one measurable lesion per RECIST 1.1; （7）Adequate organ function:\n\n   * Left ventricular ejection fraction (LVEF) ≥50%;\n   * Hemoglobin (HGB) ≥90 g\u002FL, white blood cell (WBC) ≥3.0×10⁹\u002FL, absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet (PLT) ≥80×10⁹\u002FL;\n   * Total bilirubin (TBIL) ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (≤5×ULN for liver metastasis), serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin; （8）Voluntarily participate, understand the study, and sign informed consent form.\n2. Exclusion Criteria （1）Prior systemic therapy (except recurrence ≥6 months after adjuvant chemotherapy for radical resection); （2）Severe concurrent diseases or poor physical condition unsuitable for treatment\u002Fsurgery (e.g., severely ulcerated\u002Finfected inguinal lymph nodes with high risk of poor wound healing); （3）Uncontrolled comorbidities: uncontrolled infection, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (NYHA class III\u002FIV heart failure, ≥grade 2 heart block, myocardial infarction within 12 months, unstable arrhythmia\u002Fangina, cerebral infarction within 6 months), interstitial lung disease, deep vein thrombosis\u002Fpulmonary embolism within 12 months, decompensated cirrhosis; （4）Active autoimmune diseases requiring systemic treatment within 2 years (except physiological replacement therapy); （5）Positive serological tests: HIV positive; HBsAg positive with HBV DNA ≥2000 copies\u002FmL; HCV antibody positive with positive HCV RNA; （6）Major surgery within 4 weeks prior to enrollment, prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; （7）Vaccination with anti-tumor vaccine within 4 weeks prior to enrollment or planned during the study; （8）Other conditions deemed unsuitable by the investigator.","MALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This clinical study is a Phase II research trial focused on a new preoperative treatment for men with advanced penile squamous cell carcinoma (a type of penile cancer). The cancer may be hard to treat with penile-sparing surgery, or it may have spread to nearby lymph nodes (like groin lymph nodes).\n\nWe are testing a combination of two medicines: Becotatug vedotin (a targeted therapy that finds and kills cancer cells with high levels of a protein called EGFR) and Pucotenlimab (an immunotherapy that helps your body's immune system fight cancer). The goal is to see if this combination can shrink the tumor, make surgery more likely to remove all cancer cells, and improve treatment outcomes-while keeping side effects manageable.\n\nWho can join?\n\nTo be eligible, you must:\n\nBe a man 18 years or older with confirmed penile squamous cell carcinoma; Have cancer that is hard to treat with penile-sparing surgery or has spread to regional lymph nodes; Have cancer cells that test positive for EGFR (a protein most penile cancers make); Have not received prior systemic cancer treatment (or had recurrence more than 6 months after adjuvant therapy for radical resection); Have adequate organ function (e.g., healthy heart, liver, and kidney function) to tolerate treatment; Understand the study and voluntarily agree to participate by signing an informed consent form.\n\nWhat will happen during the study? Screening (up to 28 days): You will have tests to confirm eligibility, including imaging scans, blood work, and EGFR testing on your tumor sample.\n\nPreoperative treatment (4-6 cycles): You will receive intravenous infusions of Becotatug vedotin (2.0 mg\u002Fkg) and Pucotenlimab (200 mg) every 3 weeks. Every 6 weeks, you will have imaging scans to check if the tumor is shrinking.\n\nSurgery: If the tumor responds to treatment (assessed by a team of doctors), you will undergo radical surgery to remove the cancer. If surgery is successful, you may continue Pucotenlimab as adjuvant therapy for 1 year.\n\nFollow-up: After treatment, you will be checked every 3 months for 2 years to monitor for cancer recurrence and long-term side effects.\n\nWhat are the study goals? Primary goal: To find out how many patients can have successful surgery to remove all visible cancer (R0 resection) after the combination treatment.\n\nSecondary goals: To measure how much the tumor shrinks (objective response rate), if the cancer stage improves (downstaging rate), if surgery removes all cancer cells (pathological complete response rate), how long patients stay cancer-free (disease-free survival), and how safe the treatment is.\n\nWhat are the potential risks? As with any cancer treatment, this combination may cause side effects. Common expected side effects include skin reactions (e.g., rash), digestive issues, changes in blood cell counts, liver function changes, and immune-related reactions (e.g., thyroid problems, lung inflammation). These side effects will be closely monitored by the study team, and treatments to manage them will be provided.\n\nThis study is being conducted at West China Hospital, Sichuan University. It is a single-arm trial (all participants receive the same combination treatment) and will enroll about 60 patients. The study is expected to run from April 2026 to April 2028.",[27],"Penile Cancer",[29,30,31],"penile cancer","ADC","PD-1","NOT_YET_RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":21},"2026-07-30",{"date":40,"type":21},"2031-05-01",{"name":42,"class":43},"Jiyan Liu","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":111,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":57,"type":21},999999,"80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,27,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[62,63,112,113,114,115,116,117,118,119,99,120,109,110],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":124,"type":36},"2026-06-29",{"date":126,"type":36},"2013-11-01",{"date":128,"type":21},"2099-12",{"name":130,"class":43},"University of Nebraska",42,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":162,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983","NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.",{"count":140,"type":21},20,[24],"This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[144,145,146,70,147,107,27,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Vulva Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,29,184,185],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","2026-06-10",{"date":188,"type":36},"2026-06-12",{"date":190,"type":36},"2023-03-07",{"date":192,"type":21},"2027-01-01",{"name":194,"class":43},"Christian Hinrichs",3,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100488427","phase-1-e7-t-cell-receptor-tcr--t-cell-induction-therapy-for-locoregionally-advanced-hpv-associated-cancers-100488427","NCT05639972","E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers","A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.\n2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative.\n10. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate aminotransferase (AST) (SGOT)\u002F alanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n11. Participants must be able to understand and be willing to sign the written informed consent document.\n12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.\n\nNote: Patients may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.\n2. Current treatment with another investigational agent.\n3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n5. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.\n6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.\n8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":204,"type":21},15,[206,24],"PHASE1","The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.\n\nThis study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.\n\nParticipants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.",[209,150,149,154,153,156,152,158,159,160,157,144,146,70,210,27,107],"HPV-Associated Cervical Carcinoma","Vulvar Cancer",[172,212,213,214,215,216,217,164,175,167,218,219,220,221,222,223,224,225],"Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","Chemoradiation","CAR-T, cell therapy","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":188,"type":36},{"date":228,"type":36},"2025-08-11",{"date":230,"type":21},"2026-10-01",{"name":194,"class":43},2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":44},"100622499","phase-2-ql1706-plus-lenvatinib-in-previously-treated-penile-cancer-100622499","NCT07384416","QL1706 Plus Lenvatinib in Previously Treated Penile Cancer","A Phase II Study of QL1706 Combined With Lenvatinib in Patients With Previously Treated Advanced or Metastatic Penile Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Histologically or cytologically confirmed penile squamous cell carcinoma.\n3. Previous treatment with chemotherapy, immunotherapy, and\u002For targeted therapy.\n4. At least one measurable target lesion according to RECIST 1.1 criteria.\n5. ECOG performance status score of ≤ 2.\n6. Adequate bone marrow function: Hemoglobin (Hb) ≥ 75 g\u002FL, White Blood Cell count (WBC) ≥ 3.0×10⁹\u002FL, Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL, Platelet count (PLT) ≥ 100×10⁹\u002FL.\n7. Adequate organ function:\n\n   Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.\n\n   Serum creatinine ≤ 1.5 × ULN.\n8. Life expectancy of ≥ 12 months.\n9. No significant history of severe cardiac, pulmonary, hepatic, or other major organ diseases.\n10. The patient understands the study procedures and provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Participation in any investigational drug study within 4 weeks prior to the start of treatment.\n2. Concurrent active cancer other than penile squamous cell carcinoma, or a history of other malignancies within the past 5 years, except for the following:\n\n   * (1) Cured non-melanoma skin cancer;\n   * (2) Incidentally discovered, low-risk, and curative tumors, including but not limited to low-risk prostate cancer (T1a, Gleason score \\\u003C6, PSA \\\u003C0.5 ng\u002Fml) and superficial bladder cancer;\n   * (3) Other solid tumors that have undergone curative treatment with no evidence of recurrence or metastasis for 5 years or more.\n3. Other serious, poorly controlled concurrent illnesses that may be aggravated by the combination therapy, including but not limited to:\n\n   * (1) History of severe or acute exacerbation within the past 6 months involving the cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric systems;\n   * (2) Active infection requiring antibiotic treatment within 2 weeks prior to enrollment;\n   * (3) Congestive heart failure (Class III-IV);\n   * (4) Unstable angina or myocardial infarction within the past 6 months;\n   * (5) Untreated active Hepatitis B virus (HBV) infection. \\*Note: Subjects with HBV meeting the following criteria are eligible: HBV viral load must be \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before the first dose, and the subject must receive anti-HBV therapy throughout the study treatment period to prevent reactivation. Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy but require close monitoring for reactivation.\\*\n   * (6) Active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the limit of detection).\n4. Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1). \\*Inactivated seasonal influenza vaccines administered by injection are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.\\*\n5. Diagnosis of immunodeficiency or receipt of systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. \\*Physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) are permitted.\\*\n6. History of Human Immunodeficiency Virus (HIV) infection (i.e., positive HIV1\u002F2 antibody test).\n7. Systemic treatment with Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to enrollment.\n8. Active autoimmune disease that has required systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years.\n9. Any other history, disease, concurrent condition, therapy, or laboratory abnormality that, in the investigator's judgment, might compromise the results, interfere with the subject's full participation throughout the study, or make the subject unsuitable for study participation.",{"count":241,"type":21},47,[24],"This phase II clinical study aims to evaluate the efficacy and safety of QL1706 in combination with lenvatinib in patients with previously treated advanced or metastatic penile squamous cell carcinoma.\n\nThe primary objective of the study is to determine the median progression-free survival (PFS) of this regimen according to RECIST 1.1 criteria. Secondary objectives include evaluating objective response rate, disease control rate, overall survival, duration of response, safety, and the rate of conversion surgery.\n\nAll enrolled participants will receive QL1706 plus lenvatinib as induction therapy for up to four treatment cycles (21 days per cycle). After completion of four cycles, tumor response will be assessed by imaging and multidisciplinary team (MDT) evaluation. Patients whose tumors become resectable and who are considered likely to benefit from surgery may undergo conversion surgery. Patients who are not eligible for surgery will continue study treatment.\n\nFollowing induction therapy or surgery, participants may continue QL1706 plus lenvatinib as continuation therapy. QL1706 will be administered for up to one year, and lenvatinib will be continued until disease progression according to RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.\n\nTumor assessments will be performed using imaging studies such as CT or MRI at scheduled intervals. Safety will be monitored through clinical evaluations, laboratory testing, and adverse event reporting throughout the study.",[27],"2026-05-05",{"date":247,"type":36},"2026-05-08",{"date":249,"type":21},"2026-04-10",{"date":251,"type":21},"2031-01-31",{"name":253,"class":43},"Sun Yat-sen University",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100622057","defeating-penile-cancer-2-100622057","NCT07378670","DEfeating PEnile CAncer-2","Robot-assisted vs. Open Inguinal Lymphadenectomy for Penile Cancer - a Prospective Randomized Trial With a Supporting Translational Program","DEPECA-2","Inclusion Criteria:\n\n* 1\\. Patient has provided written informed consent.\n* 2\\. Male patient ≥ 18 years at time of signing the informed consent form.\n* 3\\. Patient has histologically proven penile squamous cell carcinoma.\n* 4\\. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1\u002F2) inguinal lymphadenectomy, i.e.:\n\n  * pT1a, G2, cN0 OR\n  * pT1b- pT3, any G, cN0 OR\n  * pT1-pT3, any G, cN1-2\n* 5\\. Patients has adequate hepatic, renal and bone marrow function:\n\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1.5 x 109 \u002FL\n  * Platelets ≥ 100 x 109 \u002FL\n  * International normalized ratio (INR) \u002F activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants. Anticoagulation is accepted according to the surgeon's practice.\n* 6\\. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.\n* 7\\. Performance status of the patient is judged by the treating physician as appropriate to undergo surgery.\n\nExclusion Criteria:\n\n* 1\\. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging).\n* 2\\. Patient has distant metastases.\n* 3\\. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa.\n* 4\\. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or radiotherapy in the groin or pelvic area.\n* 5\\. Patient participates in competing trials affecting the effects of the surgery or outcome measures.\n* 6\\. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences.\n* 7\\. Patient has any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.\n* 8\\. Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities.\n* 9\\. Patient is unable to consent because he does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.",{"count":263,"type":21},80,[265],"NA","Open inguinal lymphadenectomy (O-ILAD) is the current standard of care for invasive staging and simultaneously the curative approach for patients with PeCa and elevated risk for or clinically detectable lymphatic disease in the groin. The high rate of complications of this surgical procedure, which are often mutilating and associated with a long-term convalescence, leads to a critical delay in initiation of adjuvant systemic therapy. Being in apprehension of these postsurgical adversities, physicians are often reluctant with indicating this procedure, thus depriving their patients of the vital prognosis-relevant care. In the sum, these obstacles inevitably result in inferior oncologic outcomes. Aiming to decrease postsurgical detrimental sequelae, several attempts to modify radicality of the technique, including inter alia a radioguided approach of sentinel lymph node resection, have been presented in the last decades. Unfortunately, utilization of the sentinel lymph node technique outside of a few highly specialized referral centers is prone to a significant false negativity, while other approaches are associated with inconsistent oncological and perioperative outcomes, hence precluding a general breakthrough in the surgical management of the groin lymph nodes. Thus, a high unmet medical need exists for the establishment of an approach with the lowest possible rate of complications and at the same time the optimal oncological safety.\n\nIn this context, preliminary evidence from small sample studies points to a promising potential of minimally invasive surgery to be further tested in the setting of inguinal lymphadenectomy. A recent retrospective single-center report on robot-assisted inguinal lymphadenectomy (R-ILAD) showed that the rate of major complications was only as low as 2%. On the contrary, the rate of major complications in our own and other O-ILAD series was approx. 30%.\n\nDEPECA-2 is a prospective randomized multicenter trial, in which R-ILAD will be tested vs. O-ILAD on the 1b level of evidence for the first time. The scientific value of the project is significantly substantiated by a comprehensive translational research program, which includes inflammatory and oncologic biomarker research, as well as functional validation in preclinical models. The results of this trial will foster further optimization of outcomes in the surgical management of PeCa.",[27,268],"Penile Neoplasms Malignant",[270,271,272],"robotic inguinal lymph node dissection","inguinal lymphadenectomy","surgical outcome","2026-04-11",{"date":275,"type":36},"2026-04-15",{"date":249,"type":36},{"date":278,"type":21},"2031-11-30",{"name":280,"class":43},"University Hospital Tuebingen",9,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":44},"100597116","phase-1-mrg003-plus-hx008-as-first-line-treatment-for-egfr-positive-locally-advanced-or-metastatic-penile-squamous-cell-carcinoma-100597116","NCT07054307","MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma","MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase I Clinical Trial","MH-Penile-001","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed unresectable, locally advanced, or metastatic penile squamous cell carcinoma.\n2. EGFR expression (defined as IHC 1+, 2+, or 3+) confirmed by the institutional pathology department using primary or metastatic tumor tissue samples.\n3. No prior systemic therapy for advanced disease.\n4. Male, aged ≥18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with a life expectancy ≥3 months.\n6. At least one measurable lesion per RECIST 1.1 criteria.\n7. Adequate organ function (based on institutional laboratory reference ranges):\n\n   Left ventricular ejection fraction (LVEF) ≥50%.\n\n   Hematology:\n\n   Hemoglobin (HGB) ≥90 g\u002FL, White blood cell count (WBC) ≥3.0×10⁹\u002FL, Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, Platelet count (PLT) ≥80×10⁹\u002FL.\n\n   Biochemistry:\n\n   Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases present), Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin.\n8. Willing to provide written informed consent, with full understanding of the study requirements and commitment to comply with trial procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Patients who have received prior systemic therapy before enrollment.\n2. History of other malignancies, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other malignancies that have been disease-free for at least 5 years.\n3. Presence of central nervous system metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if they have been stable for at least 6 months, show no disease progression on imaging within 4 weeks before treatment, have no neurological symptoms, demonstrate no evidence of new or enlarging brain metastases, and have discontinued radiation, surgery, or steroid therapy for brain metastases at least 28 days prior to the first dose. Carcinomatous meningitis is excluded regardless of clinical stability.\n4. Severe or uncontrolled concurrent diseases, including uncontrolled infections, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (such as NYHA Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the past 12 months, unstable arrhythmia or angina, or cerebral infarction within the past 6 months), pulmonary diseases (such as interstitial lung disease, chronic obstructive pulmonary disease, or a history of symptomatic bronchospasm), deep vein thrombosis or pulmonary embolism within the past 12 months, or decompensated cirrhosis.\n5. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are permitted.\n6. Positive serological virology test results, including HIV positivity, HBsAg positivity with detectable HBV DNA (≥2000 copies\u002FmL), or HCV antibody positivity (eligible only if HCV RNA PCR-negative).\n7. Major surgery within 4 weeks before enrollment, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n8. Administration of or plans to receive anti-cancer vaccines within 4 weeks before enrollment or during the study.\n9. Clinically significant pleural effusion or ascites, as determined by the investigator to be unsuitable for enrollment.\n10. Any other condition considered by the investigator to make the patient ineligible for the clinical study.",{"count":291,"type":21},10,[206],"Penile squamous cell carcinoma (PSCC) is a rare malignancy, with stage IV patients exhibiting a 2-year overall survival (OS) rate of 21% and a 5-year survival rate of 0%. Both the National Comprehensive Cancer Network (NCCN) and European Association of Urology (EAU) guidelines recommend chemotherapy as the first-line treatment. However, the efficacy of chemotherapeutic agents in PSCC remains suboptimal, and options after chemotherapy failure are extremely limited. In recent years, targeted therapy and immunotherapy have demonstrated potential in treating this disease. Combination therapies based on chemotherapy, particularly chemoimmunotherapy combined with targeted therapy, have shown promising antitumor effects. Nevertheless, these regimens are associated with significant adverse effects and impose high physical demands on patients.\n\nTherefore, this study aims to explore a \"highly effective and low-toxicity\" first-line treatment regimen for advanced PSCC patients. The objective is to evaluate the combined therapeutic efficacy of an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (MRG003) and an immune checkpoint inhibitor (HX008) through a single-arm, phase I, prospective clinical trial.",[27],[29,30,31],"2026-03-31",{"date":298,"type":36},"2026-04-07",{"date":300,"type":36},"2026-02-12",{"date":302,"type":21},"2030-07-30",{"name":42,"class":43},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100631226","phase-2-a-study-of-becotatug-vedotin-combined-with-pucotenlimab-in-the-treatment-of-egfr-positive-advanced-penile-cancer-100631226","NCT07497919","A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer","A Multicenter, Single-Arm, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer in Patients Who Are Intolerant to Chemotherapy or Have Failed Chemotherapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n3. Histologically confirmed penile squamous cell carcinoma with evidence of metastasis, and EGFR expression confirmed positive by immunohistochemistry (IHC).\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST): non-lymph node lesions with a longest diameter ≥ 10 mm on computed tomography (CT) scan, or lymph node lesions with a short axis diameter ≥ 15 mm on CT scan; or evaluable cutaneous lesions per World Health Organization (WHO) criteria.\n5. Have received at least one prior line of chemotherapy, or be deemed chemotherapy-intolerant by the investigator.\n6. Adequate organ and bone marrow function, as defined by the following laboratory criteria within the screening period:\n\n1)Hemoglobin \\> 8.5 g\u002FdL, without blood transfusion or erythropoietin administration within the preceding 14 days; 2)Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, without granulocyte colony-stimulating factor administration within the preceding 14 days; 3)Platelet count (PLT) ≥ 90 × 10⁹\u002FL, without blood transfusion within the preceding 14 days; 4)Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (for patients with Gilbert's syndrome, ≤ 3 × ULN is permitted); 5)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (if liver metastasis is present, ALT and AST ≤ 5 × ULN is permitted); 6)Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); 7)Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; 8)Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range; subjects with an abnormal baseline TSH but normal total T3 (or FT3) and FT4 levels are also eligible.\n\n7.Expected survival of more than 3 months.\n\n\\-\n\nExclusion Criteria:\n\n1. Diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ).\n2. Prior treatment with an ADC drug containing monomethyl auristatin E (MMAE) as the cytotoxic moiety, or prior treatment with a PD-(L)1 inhibitor.\n3. Currently participating in an interventional clinical study, or having received other investigational agents or investigational device therapy within 4 weeks prior to the first dose.\n4. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.\n5. Major surgical procedure (excluding biopsy-only procedures) within 4 weeks prior to the first dose of study drug, or anticipated major surgery during the study period.\n6. Hereditary bleeding tendency, coagulation disorder, or history of thrombosis.\n7. History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n8. Known hypersensitivity to the active ingredients or excipients of the study drugs vibecotamab and putelimab.\n9. Inadequate recovery from toxicity and\u002For complications caused by any prior intervention (i.e., ≤ Grade 1 or baseline levels, excluding fatigue or alopecia) before starting treatment.\n10. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1\u002F2 antibody).\n11. Untreated active hepatitis B (defined as positive HBsAg plus HBV-DNA copy number above the upper limit of normal of the local laboratory).\n\n    \\*Note: Subjects with hepatitis B meeting the following criteria are eligible: HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) before the first dose; subjects must receive anti-HBV therapy throughout the study treatment period to prevent viral reactivation.\n\n    For subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\n\n    Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection).\\*\n12. Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1).\n\n    Note: Administration of inactivated seasonal influenza vaccine via injection within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not allowed.\n13. Presence of any severe or uncontrolled systemic disease, such as:\n\n1)Clinically significant and symptomatic uncontrolled abnormalities in cardiac rhythm, conduction, or morphology on resting electrocardiogram (ECG), e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation; 2)Unstable angina pectoris, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class ≥ 2; 3)Uncontrolled hypertension (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg); 4)Active pulmonary tuberculosis; 6)Active or uncontrolled infection requiring systemic therapy; 7)Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 8)Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 9)Uncontrolled diabetes mellitus (fasting blood glucose (FBG) \\> 10 mmol\u002FL); 10)Urine routine test showing urine protein ≥ ++, confirmed 24-hour urinary protein quantification \\> 1.0 g; 14.Psychiatric disorders that prevent compliance with study treatment; Any other medical history, evidence of disease, treatment, or abnormal laboratory value that could interfere with study results, prevent the subject from completing the study, or for which the investigator considers the subject to be otherwise ineligible or at potential risk for participation.",{"count":140,"type":21},[24],"Penile cancer is a rare malignant tumor of the male genitourinary system, with 95% being squamous cell carcinoma. Due to social factors, delayed diagnosis is common, leading to a high rate of lymph node metastasis (17%-45% at diagnosis), which significantly impairs quality of life and prognosis. The 5-year survival rate is 27% for patients with lymph node metastasis and 0%-17% for those with pelvic lymph node metastasis (N3).\n\nCurrent standard treatments recommended by guidelines include surgery and chemotherapy. However, the neoadjuvant TIP regimen (paclitaxel + ifosfamide + cisplatin) in locally advanced disease yields an objective response rate (ORR) of 50%, pathological complete response (pCR) rate of 10%, median progression-free survival (PFS) of 8.1 months, and median overall survival (OS) of 17.1 months. For advanced patients, no standard effective treatments exist after platinum-based chemotherapy resistance, highlighting an urgent need for more effective combination therapies.\n\nHigh expression of PD-L1 (30%-70%) and EGFR (40%-80%) is common in penile squamous cell carcinoma, especially in poorly differentiated, late-stage disease with lymph node metastasis. A prospective phase II study showed that toripalimab (immunotherapy) combined with nimotuzumab (anti-EGFR antibody) and paclitaxel-based chemotherapy, followed by consolidation surgery, achieved an ORR of 82.8%, pCR rate of 48.3%, 2-year OS rate of 72.4%, and 2-year PFS rate of 65.5%; 41.4% of patients had grade 3-4 treatment-related adverse events, with no treatment-related deaths.\n\nAlthough immune checkpoint inhibitors and anti-EGFR targeted therapy demonstrate preliminary antitumor activity in advanced penile cancer, their clinical efficacy remains suboptimal with substantial toxicities, thus warranting the development of more effective combinatorial therapeutic strategies.",[27],"2026-03-23",{"date":317,"type":36},"2026-03-27",{"date":319,"type":21},"2026-05-01",{"date":321,"type":21},"2029-05-01",{"name":323,"class":43},"Fudan University",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":333,"conditions":334,"keywords":338,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":232},"100459570","lymphedema-after-urologic-surgery-100459570","NCT05264337","Lymphedema After Urologic Surgery","Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection","Inclusion Criteria:\n\n* Patients undergoing urologic surgery with lymph node dissection\n\nExclusion Criteria:\n\n* None",{"count":332,"type":21},400,"Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.",[335,336,337,27],"Urinary Bladder Neoplasms","Prostatic Neoplasms","Testicular Neoplasms",[339,340],"Lymphedema","Lymph Node Excision","2026-01-15",{"date":343,"type":36},"2026-01-16",{"date":345,"type":36},"2022-03-14",{"date":347,"type":21},"2030-01",{"name":349,"class":350},"Vastra Gotaland Region","OTHER_GOV",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":232},"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",{"count":360,"type":21},27,[24],"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",[364,365,366,27,367,368],"Urologic Neoplasms","Urogenital Neoplasms","Male Urogenital Diseases","Penile Squamous Cell Carcinoma","Locally Advanced Penile Carcinoma","2025-12-05",{"date":371,"type":36},"2025-12-08",{"date":373,"type":36},"2024-08-13",{"date":375,"type":21},"2028-01-14",{"name":377,"class":43},"The Netherlands Cancer Institute",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":405,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":44},"100568639","phase-2-ivonescimab-in-the-treatment-of-multiple-advanced-tumors-100568639","NCT06683846","Ivonescimab in the Treatment of Multiple Advanced Tumors","Ivonescimab (PD-1\u002FVEGF Bispecpecial Antibody) in the Treatment of Multiple Advanced Tumors: a Multi-cohort, Multi-center, Single-arm Phase II Study","Inclusion Criteria:\n\n* Individuals able to understand and give written informed consent.\n* Histologically or cytologically confirmed cancer of one of the following types:\n\nPAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom\n\n* Stage IV disease\n* Adequate performance status (ECOG 0-2)\n* Expected survival ≥ 3 months.\n* Measurable disease by CT or MRI, Or lesions with skin infiltration.\n* Adequate hematology without ongoing transfusional support (hemoglobin \\> 9 g\u002FdL, absolute neutrophil count (ANC) \\> 1,500 per mm\\^3, platelets \\> 100,000 per mm\\^3).\n* Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).\n* Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 \u002FPT≤1.5×ULN, aPTT≤1.5×ULN.\n* Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.\n* Ability to comply with research visit schedules and other protocol requirements.\n\nExclusion Criteria:\n\n* With any severe and\u002For uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar \\[FBG\\] \\>10mmol\u002FL);\n\n  ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;\n* With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU\u002Fml or ≥10\\^4 copies\u002Fml; HCV reference: HCV RNA≥2000 IU\u002Fml or ≥10\\^4 copies\u002Fml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA\\\u003C10\\^4 IU\u002Fml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);\n* History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;\n* Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;\n* Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;\n* Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;\n* History of severe allergies;\n* At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;\n* History of substance abuse with an inability to abstain or a history of mental illness;\n* Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility;\n* Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and\u002For unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;",{"count":332,"type":21},[24],"The goal of this clinical trial is to learn if Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor.\n\ncohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer).\n\ncohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified).\n\ncohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.).\n\ncohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases.\n\nIt will also learn about the safety of Ivonescimab. The main questions it aims to answer are:\n\nDoes Ivonescimab improve the objective response rate and prolong the survival of participants? What medical problems do participants have when taking Ivonescimab?\n\nParticipants will:\n\nReceive Ivonescimab 20mg\u002Fkg intravenously every 21 days until disease progression, intolerable toxicity, or full 2 years of treatment, whichever occurs first.\n\nBe performed imaging evaluation according to RECIST 1.1 every 9 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria",[389,390,391,392,393,102,394,395,396,397,27,398,399,400,401,402,403,81,404],"Pheochromocytoma\u002FParaganglioma","Rhabdomyosarcoma","Paget Disease, Extramammary","Renal Angiomyolipoma","Perivascular Epithelioid Cell Tumor, Malignant","Urachal Cancer","Neuroendocrine Cancer","Basal Cell Carcinomas","Sarcomatoid Carcinoma","Adrenal Cortical Cancer","Germ Cell Cancer Metastatic","Non-Clear Cell Renal Cell Carcinoma","Prostate Cancers","Clear Cell Renal Cancer","Urothelial Carcinoma","Rare Tumors",[406,407,166],"rare tumor","Ivocizumab","2025-08-19",{"date":410,"type":36},"2025-08-24",{"date":412,"type":36},"2024-11-20",{"date":414,"type":21},"2027-11-30",{"name":323,"class":43},{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":44},"100600771","phase-2-a-phase-ii-randomized-study-to-assess-maintenance-therapy-with-cemiplimab-versus-best-supportive-care-after-1st-line-platinum-based-chemotherapy-in-advancedrecurrent-penile-cancer-100600771","NCT07101822","A PHASE II, RANDOMIZED STUDY TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED\u002FRECURRENT PENILE CANCER","BRAVA PENILE","Inclusion Criteria:\n\n1\\) Male participants. 2) At least 18 years old on the day of signing the informed consent. 3) Histologically confirmed diagnosis of penile squamous cell carcinoma, clinical stages III-IV or relapsed disease, not amenable of curative intent therapy - as per AJCC 8th edition. 4) Measurable disease (as per RECIST v1.1) prior to starting first-line chemotherapy. Lesions located in a previously irradiated area are deemed as measurable if progression has been shown in such lesions. 5) Previous chemotherapy performed in localized disease setting, with curative intent and platinum-based is allowed, provided that the time off this treatment is longer than 6 months. 6) Previous first-line chemotherapy should have been comprised of at least 4 cycles and no more than 6 platinum-based chemotherapy cycles. 7) No evidence of progressive disease after completing first-line chemotherapy (e.g., ongoing complete response (CR), (partial response) PR or stable disease (SD) as per RECIST v1.1 guidelines). 8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.\n\nExclusion Criteria:\n\n1\\) History of allergy or hypersensitivity to the study drug components. 2) Persisting NCI CTCAE v5.0 Grade \\> 1 toxicity related to previous therapy; however, Grade ≤ 2 sensory neuropathy and Grade ≤ 2 chronic kidney disease are acceptable. 3) Previous immune therapy with IL-2, IFN-α, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-T cytotoxic lymphocyte related to antigen-4 (CTLA-4), or any other antibody or drug specifically targeted to T-cell co-stimulation or immune checkpoint pathways. 4) Untreated or active primary brain tumor, metastases to central nervous system, leptomeningeal disease or spinal cord compression. 5) History of allogenic organ transplant. 6) Ongoing or recent evidence (within 5 years) of significant autoimmune disease requiring treatment with systemic immunosuppressants. 7) History of other primary malignancy within the last 3 years, except locally curable cancers which have been apparently cured, such as skin basal- or squamous-cell cancer, superficial bladder cancer, breast carcinoma in situ or cervical carcinoma in situ. 8) Uncontrolled infection by human immunodeficiency virus, hepatitis B or C infection; or immunodeficiency diagnosis. 9) Have received a live vaccine within 4 weeks of the planned start of the study drug. 10) Have received any previous systemic biological therapy within 5 half-lives of the first study therapy dose. Exception: participants previously treated with bevacizumab,\n\ncetuximab, rituximab or other non-immunomodulating antibodies with half-lives longer than 7 days are allowed after a discussion with the sponsor, if at least 28 days have elapsed since last treatment",{"count":131,"type":21},[24],"This is a phase II, randomized study which will enroll participants given 4 to 6 cycles of first-line platinum-based chemotherapy treatment for advanced penile SCC not amenable by curative surgical treatment (stages III-IV as per American Joint Committeeon Cancer - AJCC - 8th) recurrent and who did not progress at the end of these 4 to 6 cycles. Participants eligible for the study will be randomized between 4 and 8 weeks after the last chemotherapy cycle to receive: - Cemiplimab maintenance plus best supportive care: cemiplimab 350 mg IV every 3 weeks until week 24, disease progression, unacceptable toxicity or consent withdrawal. patients who continue to derive clinical benefit on the experimental arm may continue to receive treatment until week 48. - Best supportive care.",[27],"2025-07-28",{"date":429,"type":36},"2025-08-03",{"date":431,"type":21},"2025-12",{"date":433,"type":21},"2028-12",{"name":435,"class":43},"Hospital Israelita Albert Einstein",{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":44},"100548002","phase-2-tip-regimen-combined-with-triplizumab-neoadjuvant-therapy-for-locally-advanced-penile-cancer-100548002","NCT06415318","TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer","A Single-center, Single-arm Clinical Study of TIP(Paclitaxel + Ifosfamide + Cisplatin) Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer","Inclusion Criteria:\n\n1. Squamous cell carcinoma confirmed by histology or cytology;\n2. Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3);\n3. No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months;\n4. There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1;\n5. the Eastern Cooperative Oncology Group (ECOG) scored 0-2;\n6. Blood marrow function: Hemoglobin(Hb) \\>\u002F= 80g\u002FL; White blood cell count \\>\u002F= 3.0x10\\^9\u002FL; Neutrophil count \\>\u002F= 1.5x10\\^9\u002FL; Platelet count \\>\u002F = 100x10\\^9\u002FL;\n7. Liver function: AST, ALT, ALP \\\u003C\u002F= 2.5 ULN; Total bilirubin \\\u003C\u002F= 1.5 ULN;\n8. Estimated survival \\>\u002F= 12 months;\n9. No prior serious disease history of a systemic organ;\n10. The participant understands this study procedure and signs the informed consent.\n\nExclusion Criteria:\n\n1. Peripheral neuropathy degree \\>\u002F=2 (affecting patient's function);\n2. Previously received any other experimental drug treatment within 4 weeks before enrollment;\n3. Patients with other cancer at present, or have other malignant tumor histories within the past 5 years. Except for (1) Cured skin non-malignant melanoma; (2) Curable tumor, including low-risk prostate cancer (T1a, Gleason score\\\u003C6, PSA\\\u003C0.5ng\u002Fml), superficial bladder cancer and so on; (3) Other solid tumors have received radical treatment, and no recurrence or metastasis has been found at least 5 years;\n4. Other serious or poorly controlled concomitant diseases, including but not limited to (1) Severe or acute attack disease history of cardiovascular, liver, respiratory, kidney, blood, endocrine or neuropsychiatric system within 6 months; (2) Active infection history and needed antibiotic treatment within 2 weeks before enrollment; (3) Congestive heart failure (grade III-IV); (4) Unstable angina pectoris or myocardial infarction history within 6 months","75 Years",{"count":445,"type":21},25,[24],"Primary Objective: To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with Toripalimab as a neoadjuvant treatment in locally advanced penile cancer",[27],"2025-04-16",{"date":451,"type":36},"2025-04-22",{"date":453,"type":36},"2024-05-31",{"date":455,"type":21},"2027-12-01",{"name":253,"class":43},{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":468,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":44},"100568676","phase-2-multi-cohort-single-arm-phase-ii-study-of-albumin-paclitaxel-ifosfamide-and-cisplatin-in-the-treatment-of-rare-advanced-tumors-100568676","NCT06684327","Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors","Inclusion Criteria:\n\n* Individuals able to understand and give written informed consent.\n* Histologically or cytologically confirmed cancer of one of the following types:\n\nPAGET's disease of scrotum with infiltrating sweat gland carcinoma Rhabdomyosarcoma Testicular cancer Penile cancer Urachal cancer\n\n* Stage IV disease\n* Adequate performance status (ECOG 0-2)\n* Expected survival ≥ 3 months.\n* Measurable disease by CT or MRI, Or lesions with skin infiltration.\n* Adequate hematology without ongoing transfusional support (hemoglobin \\> 9 g\u002FdL, absolute neutrophil count (ANC) \\> 1,500 per mm\\^3, platelets \\> 100,000 per mm\\^3).\n* Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).\n* Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 \u002FPT≤1.5×ULN, aPTT≤1.5×ULN.\n* Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.\n* Ability to comply with research visit schedules and other protocol requirements.\n\nExclusion Criteria:\n\n* 1\\. Active or uncontrolled severe infections (≥CTCAE Level 2) requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infections.\n* 2\\. Active hepatitis (transaminases not within inclusion criteria; HBV reference: HBV DNA ≥2000 IU\u002Fml or ≥10\\^4 copies\u002Fml; HCV reference: HCV RNA ≥2000 IU\u002Fml or ≥10\\^4 copies\u002Fml; after nucleoside antiviral treatment below the above standards, may be eligible; chronic HBV carrier with HBV DNA \\\u003C10\\^4 IU\u002Fml, must receive antiviral treatment during the study period to be eligible).\n* 3\\. Renal failure requiring hemodialysis or peritoneal dialysis.\n* 4\\. History of immunodeficiency, including HIV positive or having other acquired\u002Fcongenital immunodeficiency diseases, or organ transplant history.\n* 5\\. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness, and constipation.\n* 6\\. History of active tuberculosis.\n* 7\\. Uncontrolled ascites, pleural effusion, or pericardial effusion requiring repeated drainage.\n* 8\\. Patients who have undergone major organ transplantation.\n* 9\\. Individuals who have undergone major surgical procedures, open biopsies, or obvious traumatic injuries within 28 days prior to the start of the study; or have unhealed wounds or fractures for a long time;\n* 10\\. Individuals who have participated or are currently participating in another clinical study within the past 4 weeks prior to the start of the study;\n* 11\\. Individuals with a history of severe allergies;\n* 12\\. Individuals at risk of bleeding, or with impaired coagulation function, or who are currently receiving thrombolytic therapy;\n* 13\\. Individuals with a history of substance abuse with no ability to abstain or with a mental disorder.\n* 14\\. According to the investigator's judgment, subjects with serious adverse effects on their safety or completion of the study, or those with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or those with other reasons deemed unsuitable for enrollment by the investigator. Subjects with a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of epilepsy prone.",{"count":464,"type":21},100,[24],"The goal of this clinical trial is to learn if albumin-paclitaxel, ifosfamide and cisplatin (Nab-TIP) works to treat advanced rare tumors including PAGET's disease of scrotum with infiltrating sweat gland carcinoma （cohort 1）, rhabdomyosarcoma (cohort 2), testicular cancer (cohort 3), penile cancer (cohort 4), and urachus cancer (cohort 5) . It will also learn about the safety of Nab-TIP. The main questions it aims to answer are:\n\nDoes Nab-TIP improve the objective response rate and prolong the survival of participants? What medical problems do participants have when receiving the regimen of Nab-TIP?\n\nParticipants will:\n\nReceive albumin-paclitaxel 260mg\u002Fm2 d1, isocyclophosphamide 1500mg\u002Fm2 d2-5, and cisplatin 25mg\u002Fm2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first.\n\nBe performed imaging evaluation according to RECIST 1.1 every 6 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria",[391,390,83,27,394],[406,469,470,471],"albumin-paclitaxel","ifosfamide","cisplatin","2024-12-18",{"date":474,"type":36},"2024-12-20",{"date":476,"type":36},"2024-11-30",{"date":478,"type":21},"2027-12-30",{"name":323,"class":43},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":44},"100567318","validation-of-icg-99mtc-nanoscan-as-hybrid-tracer-for-sentinel-node-biopsy-100567318","NCT06666634","Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy","NANOSCAN","Inclusion Criteria:\n\n* Patient who will undergo a sentinel node procedure in routine care.\n* Patients \\> 18 years;\n* Patients presenting with:\n* a primary cutaneous melanoma of head\u002Fneck or upper part of the trunk or extremities;\n* OR patients presenting with a primary oral cavity malignancy T1-2N0\n* OR patients with primary penile cancer\n* Patients with clinical N0 stage;\n* Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;\n* Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting\n\nExclusion Criteria:\n\n* Patients with known allergy to patent blue dye or nanocolloid;\n* Patients who are pregnant or breast-feeding mothers;\n* History of hypersensitivity reactions to products containing human serum albumin;\n* History of iodine allergy\n* Hyperthyroid or thyroidal adenoma\n* Kidney insufficiency\n* Incapacity or unwillingness of participant to give written informed consent;",{"count":488,"type":21},29,[265],"99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.",[27,101,492],"Oral Cancer",[494,495,496,497,498],"Fluorescence","Radioactivity","Indocyanine green","Clinical node negative patients","Surgical staging","2024-10-29",{"date":501,"type":36},"2024-10-30",{"date":503,"type":36},"2023-04-01",{"date":505,"type":21},"2025-08",{"name":377,"class":43},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":44},"100557946","phase-1-scg142-tcr-t-cells-for-human-papillomavirus-associated-carcinomas-100557946","NCT06544720","SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas","A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas","Key Inclusion Criteria:\n\n1. Greater than or equal to 18 years of age\n2. HPV associated carcinomas\n3. Patients must have at least one measurable lesion defined by RECIST 1.1\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nKey Exclusion Criteria:\n\n1. Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.\n2. Patients with active autoimmune diseases.\n3. Patient has a known active Hepatitis B or Hepatitis C.\n4. Other severe medical conditions that may limit subject\\'s participation in this trial.",{"count":5,"type":21},[206],"A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.",[518,144,519,70,147,107,27,149],"Human Papillomavirus Associated Carcinomas","Head and Neck Cancers","2024-08-06",{"date":522,"type":36},"2024-08-09",{"date":524,"type":36},"2023-08-02",{"date":526,"type":21},"2026-12-31",{"name":528,"class":43},"The Affiliated Hospital of Qingdao University",{"id":530,"slug":531,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":44},"100473621","the-role-of-functional-magnetic-resonance-imaging-in-preoperative-assessment-of-primary-penile-carcinoma-100473621","NCT05447273","The Role of Functional Magnetic Resonance Imaging in Preoperative Assessment of Primary Penile Carcinoma","Inclusion Criteria:\n\n* newly diagnosed penile squamous cell carcinoma (SCC)\n* the patient will benefit from organ-sparing surgery (OSS)\n* signed broad consent for cancer research\n\nExclusion Criteria:\n\n* N\u002FA",{"count":20,"type":21},"The proposed project is intended as a prospective study that includes 60 patients with newly diagnosed penile squamous cell carcinoma (SCC) referred to Oslo University Hospital (OUH), Radiumhospitalet, for surgery, primarily organ-sparing surgery (OSS).\n\nOSS may improve not only quality of life, but also quality of sexual function. However, there is a potential for increased risk of local recurrence after OSS compared to the amputation of the penis. Appropriate preoperative staging, including multi-parametric magnetic resonance imaging (mpMRI), can substantially improve selection of patients and decrease the recurrence rate after surgery.\n\nMpMRI without artificial erection is promising diagnostic tool that is poised to be all-in-one solution for staging and preoperative assessment of primary penile cancer, especially prior to OSS. The method is non-invasive and thus comfortable to perform for most of the patients. Novel MRI techniques are not incorporated into current clinical recommendations, and the potential of new, functional sequences has not been evaluated before. The accuracy of functional, non-erectile mpMRI for detecting and staging of primary penile cancer is not known. Thus, the main purpose of this study is to assess the diagnostic value of this method for preoperative assessment of penile cancer.",[27],"2024-04-01",{"date":540,"type":36},"2024-04-03",{"date":542,"type":36},"2022-07-15",{"date":347,"type":21},{"name":545,"class":43},"Oslo University Hospital",{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":44},"100508357","a-novel-imaging-protocol-in-use-to-identify-lymph-nodes-and-organs-of-interest-100508357","NCT05899361","A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest","A Pilot Study of a Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest for Surgical Dissection Within Urologic Regions of Interest.","Inclusion Criteria:\n\n* Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management\n* Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy.\n* Subjects must have had either of the following scans: CT, PET or MR of acceptable quality at Brigham and Women's Hospital within the past year.\n* Subjects must also be scheduled to undergo lymph node dissection for a urologic cancer or organ removal of any of the following urologic regions of interest: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum\n* Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and\u002For a urologic organ removal within any OR at BWH.\n\nExclusion Criteria:\n\n* Severely impaired renal function with an EGFR \\\u003C 30 mL\u002Fmin\u002Fbody surface area\n* Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI\n* History of hypersensitivity or other contraindication to contrast media\n* Contraindication to general anesthesia\n* Pregnancy",{"count":291,"type":21},[265],"This research study is a pilot clinical trial, which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy and\u002For organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest (Bladder, Prostate, Testicular, Kidney, Urethral, and Penis), by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.",[557,364,80,82,83,81,85,27],"Urologic Cancer",[559,557,364,80,82,83,81,85,27],"Lymph Node Dissection","2023-10-23",{"date":562,"type":36},"2023-10-24",{"date":564,"type":36},"2023-08-30",{"date":566,"type":21},"2026-12-25",{"name":568,"class":43},"Dana-Farber Cancer Institute"]