[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urogenital-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urogenital-neoplasms":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,48,73,112,135,165,192,224,254,312,344],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100433365","a-multi-center-natural-history-of-urothelial-cancer-and-rare-genitourinary-tract-malignancies-100433365",false,"NCT04923178","A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator's discretion.\n* Age \\>=18 years.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-None","ALL","18 Years",{"count":18,"type":19},1100,"ESTIMATED","OBSERVATIONAL","Background:\n\nTumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.\n\nObjective:\n\nTo learn more about urinary tract cancers.\n\nEligibility:\n\nPeople ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.\n\nDesign:\n\nParticipants will be screened with questions about their medical history. Their medical records will be reviewed.\n\nParticipants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.\n\nParticipants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.\n\nParticipants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.\n\nParticipants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.\n\nSome blood and tumor samples may be used for genetic tests.\n\nParticipants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....",[23,24,25,26,27],"Urothelial Cancer","Bladder Cancer","Genitourinary Cancer","Urogenital Neoplasms","Urogenital Cancer",[29,30,31,32,33,34],"bladder\u002Furachal adenocarcinoma","renal tumors","penile cancers","small cell neuroendocrine carcinoma of the prostate","Renal Cell Carcinoma","Natural History","RECRUITING","2026-06-04",{"date":38,"type":39},"2026-06-05","ACTUAL",{"date":41,"type":39},"2022-10-24",{"date":43,"type":19},"2042-12-01",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100380606","phase-1-bintrafusp-alfa-m7824-and-pds01adc-alone-and-in-combination-with-stereotactic-body-radiation-therapy-sbrt-in-adults-with-metastatic-non-prostate-genitourinary-malignancies-100380606","NCT04235777","Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies","A Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed diagnosis of a metastatic non-prostate genitourinary tumor.\n* Participants must have metastatic disease defined as new or progressive lesions on cross-sectional imaging. Radiological evaluation should occur within 21 days prior to enrollment.\n* Participants must have evaluable or measurable disease, per RECIST 1.1.\n* Participants in Arms 2 and 3 must have at least one site of disease that is amenable to irradiation (irradiation of up to 4 different sites is permitted)\n* Participants must have at least one measurable site of disease (according to RECIST criteria) that will not be irradiated.\n* Participants may have been previously treated with cytotoxic chemotherapy regimen or targeted agent. Participants may have received any number of prior cytotoxic agents.\n* Participants may have been previously treated with radiation therapy. However, re-irradiation of a previously irradiated site is not permitted unless explicitly discussed with protocol PI and treating radiation oncologist.\n* Participants may have had prior immunomodulating therapy including therapy with a checkpoint inhibitor but excluding prior treatment with M7824 and\u002For PDS01ADC.\n* Participants with locally advanced\u002Fmetastatic clear cell renal cell cancer must have previously received, refused or been ineligible for either axitinib plus pembrolizumab, cabozantinib plus nivolumab, levantinib plus pembrolizumab, axitinib plus avelumab, nivolumab plus ipilumumab, cabozantinib, pazopanib, sunitinib or axitinib.\n* Participants with locally advanced or mestastatic germ cell tumors must have received, refused or been ineligible for prior bleomycin plus etoposide plus cisplatin, etoposide plus cisplatin, etoposide plus ifosfamide plus cisplatin, vinblastine plus ifosfamide plus cisplatin, paclitaxel plus ifosfamide plus cisplatin or autologous hematopoietic cell transplantation.\n* Participants with locally advanced\u002Fmetastatic urothelial cancer must have previously received, refused or been ineligible for platinum chemotherapy and\u002For single agent PD-1\u002FPD-L1 inhibitor.\n* Pre-treatment tissue availability for PD-L1 expression testing is mandatory for enrollment. If tissue is determined to be of insufficient\u002Funsuitable quality\u002Fquantity, a pre-treatment biopsy prior to initiation of study therapy will be required.\n* Male and female participants who are at least 18 years of age on the day of signing the informed consent will be enrolled in the study.\n* ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes greater than or equal to 2500mcL\n  * absolute neutrophil count greater than or equal to 1500\u002FmcL\n  * platelets greater than or equal to 100,000\u002FmcL\n  * Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) less than or equal to 1.5 X institutional upper limit of normal (ULN)\n  * Hemoglobin (Hgb) greater than or equal to 9g\u002FdL (Packed red blood cells (pRBC) transfusions are allowed to achieve acceptable Hgb)\n* Participants may have mild to moderate hepatic impairment with total bilirubin less than or equal to 3.0 x ULN.\n* For participants with liver involvement in their tumor, we allow the following: AST less than or equal to 5.0 x ULN, ALT less than or equal to 5.0 x ULN, and bilirubin less than or equal to 3.0 x ULN.\n* Calculated Creatinine clearance greater than or equal to 20 mL\u002Fmin (using either CKD-EPY equation)\n* The effects of M7824 and\u002For PDS01ADC on the developing human fetus are unknown. For this reason, individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use strict and effective contraception during treatment and after the last dose of M7824 administration - at least 65 days after for IOCBP and 125 days after for individuals able to father a child. Should IOCBPs become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately.\n* Human Immunoodeficiency Virus (HIV)-positive participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), CD4 counts are greater than 350 cells\u002Fmm3 and viral load is undetectable.\n* Participants with previously treated brain or central nervous system (CNS) metastases are eligible provided that the participant has recovered from any acute effects of radiotherapy and is not requiring steroids, and any whole brain radiation therapy was completed at least 2 weeks prior to M7824 administration, or any stereotactic radiosurgery was completed at least 2 weeks prior to M7824 administration.\n* Hepatitis B Virus (HBV) positive participants are eligible-they must have been treated and on a stable dose of antivirals \\[eg, entecavir, tenofovir, or lamivudine; (adefovir or interferon are not allowed)\\] at study entry and with planned monitoring and management according to appropriate labeling guidance.\n* Hepatitis B Virus (HCV) positive participants are eligible if participants are on active HCV therapy at study entry and must be on a stable dose without documented clinically significant impaired liver function test or hematologic abnormalities and with planned monitoring and management according to appropriate labeling guidance.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to M7824 and\u002For PDS01ADC investigational agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Participants with a history of bleeding diathesis or recent clinically significant bleeding events considered by the Investigator as high risk for investigational drug treatment are also excluded with the exception of hematuria.\n* Participants unwilling to accept blood products as medically indicated\n* Pregnant individuals are excluded from this study because M7824 and\u002For PDS01ADC are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824 and\u002For PDS01ADC, nursing should be discontinued if the nursing individual is treated with these agents.\n* Participants with any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required treatment with either systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with inflammatory bowel disease that have been in remission for at least 5 years whether or not they are currently on immunosuppressive therapy provided that they are not on systemic corticosteroids (\\> 10mg daily prednisone equivalent) are eligible.\n* Participants with any active or recent history of inflammatory bowel disease, active lupus or scleroderma or other medical conditions (i.e., pneumonits with planned SBRT to lung lesion) or genetic radiosensitivity syndromes will be excluded from the study unless deemed eligible by Principal Investigator because these diseases make the participant unsafe or ineligible for radiation therapy with SBRT.\n* Participants with a \"currently active\" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ or incidental organ-confined prostate cancer found on cystoprostatectomy (provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score \\\u003C= 3+4, Prostate-Specific Antigen (PSA) undetectable). Participants are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for \\>= 2 years and currently do not require systemic therapy.\n* Participants having tumor lesion(s) in the liver or chest which are 10 cm or larger.","120 Years",{"count":57,"type":19},100,"INTERVENTIONAL",[60],"PHASE1","Background:\n\nGenitourinary cancers are some of the most common types of cancer. They are lethal when they spread. The drug M7824 blocks the paths that cancer cells use to stop the immune system from fighting cancer. The drug PDS01ADC triggers the immune system to fight cancer. Researchers want to learn if these drugs can help fight these cancers when given with and without Stereotactic Body Radiation Therapy (SBRT) radiation.\n\nObjective:\n\nTo learn if M7824 and PDS01ADC, with or without SBRT, can help the immune system to fight cancer better.\n\nEligibility:\n\nPeople 18 and older with cancer that started in the bladder, kidneys, or other genitourinary organs (but not the prostate) and has spread to other parts of the body.\n\nDesign:\n\nParticipants will be screened with:\n\nmedical history\n\nphysical exam\n\nability to do their normal activities\n\nblood tests\n\nurine tests\n\nelectrocardiogram\n\nbody scans.\n\nParticipants will give a tumor sample or have a tumor biopsy.\n\nScreening tests will be repeated during the study.\n\nParticipants will get PDS01ADC . It is injected under the skin every 4 weeks. They will also get M7824 through an intravenous (IV) infusion every 2 weeks. For this, a small plastic tube is put into a vein in the arm. They will get these drugs in 28-day cycles until they leave the study. They may have SBRT.\n\nParticipants will give tissue and saliva samples.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will get phone calls or emails every 12 weeks indefinitely.",[23,24,25,26,27],[64,33,65,66],"Immunocytokine","Urothelial carcinoma","Immune Therapy",{"date":38,"type":39},{"date":69,"type":39},"2020-07-13",{"date":71,"type":19},"2027-12-01",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":16,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":58,"phases":83,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100471052","phase-1-anti-tumour-activity-of-177lu-rhpsma-101-injection-100471052","NCT05413850","Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.\n2. Serum testosterone levels \\\u003C50 ng\u002FdL (1.73 nmol\u002FL) after surgical or continued chemical castration.\n3. Presence of disease target or non target lesions (per RECIST v1.1) on CT\u002FMRI and\u002For presence of disease on full body 99mTc bone scan performed within 28 days of screening.\n4. Positive disease expression of PSMA as confirmed on PSMA PET\u002FCT scan.\n5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH).\n6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).\n7. Prior major surgery must be at least 12 weeks prior to study entry.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.\n9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.\n10. Adequate contraception for patients and their partners.\n11. For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.\n2. Presence of significant PSMA-negative disease on ceCT\u002FMRI scan\n3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).\n4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.\n5. Known history of haematological malignancy.\n6. Known history of central nervous system (CNS) metastases.\n7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.\n8. Known history of other solid malignancy that may reduce life expectancy and\u002For may interfere with disease assessment.\n9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent\u002Fnephrostomy.\n10. Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.\n11. Ongoing treatment with bisphosphonates for bone-targeted therapy.\n12. Severe urinary incontinence that would preclude safe disposal of radioactive urine.\n13. Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.\n14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.\n15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.\n16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.\n17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and\u002For dosimetry calculations.\n18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.\n19. Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and\u002For during study participation.\n20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema.\n21. Any history of prior thoracic external beam radiotherapy.\n22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.","MALE",{"count":82,"type":19},82,[60,84],"PHASE2","To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.",[87,88,89,26,90,91],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","mCRPC","Prostatic Neoplasms","Prostatic Diseases",[93,89,94,95,96,97,98,99,100],"PSMA","Prostate cancer","177Lu rhPSMA-10.1","18F-rhPSMA-7.3","BET-PSMA-121","Blue Earth Therapeutics Limited","Radiohybrid","Radiopharmaceuticals","2026-05-12",{"date":103,"type":39},"2026-05-14",{"date":105,"type":39},"2022-07-20",{"date":107,"type":19},"2028-03-31",{"name":109,"class":110},"Blue Earth Therapeutics Ltd","INDUSTRY",21,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100572863","association-between-the-sphertest-in-vitro-test-and-response-to-checkpoint-inhibitor-treatments-in-patients-with-advanced-or-metastatic-urothelial-carcinoma-100572863","NCT06738797","Association Between the SPHERTEST in Vitro Test and Response to Checkpoint Inhibitor Treatments in Patients With Advanced or Metastatic Urothelial Carcinoma","Evaluation de l'Association Entre Les résultats d'un Test in Vitro en Cours de développement (SPHERTEST) et la réponse Aux Traitements Par Inhibiteur du Point de contrôle Chez Des Patients Atteints de Carcinome urothélial de Stade avancé ou métastatique.","PROMES-URO","Inclusion Criteria:\n\n* Patient with histologically proven urothelial carcinoma, in a locally advanced or metastatic situation with indication for immunotherapy.\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* The subject is participating in a category 1 or drug monotherapy interventional study, or is in a period of exclusion determined by a previous study\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* History of treatment with anti-PD1 or anti-PDL1 or anti-CTLA4 within the year.\n* Pregnant, parturient or breastfeeding patient.",{"count":121,"type":19},32,"First-line systemic treatments for bladder cancer are based on a combination of cytotoxic and immunotherapy, sequentially or concomitantly. Immune checkpoint inhibition (ICPI) is a powerful treatment for patients with metastatic urothelial carcinoma (UC). Since 2017, pembrolizumab (anti-PD1) can be offered as a second-line treatment after failure of platinum agents. In patients responding to platinum salts in first-line treatment, it is possible to maintain efficacy with maintenance treatment with another ICPI, avelumab (anti-PDL1). The phase III JAVELIN BLADDER 100 study compared avelumab to supportive care alone after successful platinum-based chemotherapy. At 30 months, 19.3% of patients were still in response compared to only 6.3% in the supportive care arm. However, biomarker analysis on tumor tissue did not show a robust signature on an individual scale. Recently, two phase 3 trials in first-line were presented at the ESMO 2023 congress. The first, in patients who could receive cisplatin-based chemotherapy, found a benefit on overall survival of adding Nivolumab in combination and then maintaining it for two years. The second proposed combined Enfortumab Vedotin and Pembrolizumab versus standard chemotherapy, with an overall survival for the study arm of more than 31 months. These trials confirm the essential role of immunotherapy in urothelial carcinomas. This progress is tempered by toxicity, cost and the lack of data on patient selection and treatment sequence. Although \"prognostic\" biomarkers have been identified, they cannot guide the choice of therapy, but only predict the expected outcomes, regardless of the treatment; biomarkers capable of predicting clinical benefit (\"predictive\") are urgently needed. It is therefore essential to identify a predictive signature at the individual level. The study authors have validated an in vitro model of heterotypic spheroids (SPHERTEST) composed of commercial urothelial carcinoma tumor cells and PBMCs from healthy donors. The aim of the study is to validate this model with PBMCs from UC patients to evaluate the effects of immunotherapy on the immune response and on tumor cell survival in vitro.\n\nThe study hypothesis is that the outcome of the pre-therapeutic test based on a heterotypic spheroid model with PBMC from patients with advanced or metastatic urothelial carcinoma (SPHERTEST) is related to the response to checkpoint inhibitor (CI) treatment.",[26],"2026-01-26",{"date":126,"type":39},"2026-01-28",{"date":128,"type":39},"2024-12-12",{"date":130,"type":19},"2029-06",{"name":132,"class":133},"Centre Hospitalier Universitaire de Nīmes","OTHER",5,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":58,"phases":145,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":47},"100568351","phase-2-cd70-targeted-immunopet-imaging-of-kidney-cancer-100568351","NCT06680089","CD70-targeted immunoPET Imaging of Kidney Cancer","A Study of the Clinical Application of [18F]RCCB6 PET\u002F CT Imaging in the Diagnosis of Kidney Cancer","Inclusion Criteria:\n\n1. Aged 18-80 year-old and of either sex；\n2. Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;\n3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Pregnancy；\n2. Severe hepatic and renal insufficiency;\n3. History of serious surgery in the last month;\n4. Allergic to antibody or single-domain antibody radiopharmaceuticals.","80 Years",{"count":144,"type":19},300,[84],"The aim of this study is to establish and optimize the \\[18F\\]RCCB6 PET\u002FCT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.",[148,26,149,150],"Urologic Neoplasms","Kidney Neoplasms","Neoplasms",[152,153,154,155],"The cluster of differentiation (CD70)","Kidney tumor","Clear cell renal cell carcinoma","ImmunoPET","2025-12-25",{"date":158,"type":39},"2025-12-31",{"date":160,"type":39},"2024-11-27",{"date":162,"type":19},"2027-11",{"name":164,"class":133},"RenJi Hospital",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":80,"minAge":16,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":58,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"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":174,"type":19},27,[84],"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",[148,26,178,179,180,181],"Male Urogenital Diseases","Penile Cancer","Penile Squamous Cell Carcinoma","Locally Advanced Penile Carcinoma","2025-12-05",{"date":184,"type":39},"2025-12-08",{"date":186,"type":39},"2024-08-13",{"date":188,"type":19},"2028-01-14",{"name":190,"class":133},"The Netherlands Cancer Institute",2,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":142,"enrollmentInfo":199,"targetDuration":201,"studyType":20,"phases":4,"briefSummary":202,"conditions":203,"keywords":212,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":47},"100568077","vorolanib-in-the-second-line-treatment-of-patients-with-unresectable-or-metastatic-renal-cell-carcinoma-100568077","NCT06676527","Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma","An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects have fully understood and voluntarily signed the informed consent form (ICF);\n* 18-80 years old (at the time of signing the informed consent); Both men and women; ECOG PS score: 0-1;\n* Renal cell carcinoma with clear cell components confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components;\n* According to RECIST (version 1.1), there are targets that are considered to be observable;\n* The main organs function well.\n\nExclusion Criteria:\n\n* A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);\n* Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy within 4 weeks prior to the initial study;\n* Had major surgery within 4 weeks prior to initial study dosing (as judged by the investigator) or was in recovery;\n* A history of severe drug allergy, including but not limited to antibody drugs;\n* Patients with contraindications for immunotherapy restart;\n* A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation may require long-term adrenal corticosteroid therapy. Patients with thyroid, suprarenal, or hypopituitarism that can be controlled by hormone replacement therapy alone, type 1 diabetes mellitus, and psoriasis or vitiligo that do not require systemic treatment are eligible to participate in this study;\n* Toxicity did not resolve after previous antitumor therapy, i.e., regression to baseline, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified in inclusion\u002Fexclusion criteria. Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the drug under study may be included in the study;\n* Have central nervous system metastases and\u002For cancerous meningitis;\n* Known history of clinically significant liver disease, including those infected with viral hepatitis activity;\n* Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients with no need to drain effusion or no significant increase in effusion after 3 days of stopping drainage could be included);\n* Patients with any severe and\u002For uncontrolled disease;\n* Renal failure requires hemodialysis or peritoneal dialysis;\n* Have or have a suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.;\n* History of live attenuated vaccine vaccination within 4 weeks prior to the initial study or expected live attenuated vaccine vaccination during the study period;\n* Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders;\n* Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities, as determined by the investigator, that may increase the risks associated with study participation or that may interfere with the interpretation of the study results.",{"count":200,"type":19},39,"12 Weeks","This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.",[150,149,148,26,204,178,205,206,207,208,209,210,211],"Female Urogenital Diseases","Urogenital Diseases","Kidney Diseases","Urologic Diseases","Carcinoma","Renal Cell Cancer","Carcinoma, Renal Cell","Antineoplastic Agents",[213,214,215],"observational study","clear cell Renal Cell Carcinoma","TKIs","2025-12-04",{"date":182,"type":39},{"date":219,"type":39},"2024-09-01",{"date":221,"type":19},"2026-09-01",{"name":223,"class":133},"Jinling Hospital, China",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":58,"phases":234,"briefSummary":235,"conditions":236,"keywords":242,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100534368","phase-2-stage-ii-iiia-urothelial-cancer-randomizing-pre-operative-nivolumab-with-or-without-relatlimab-100534368","NCT06237920","Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","TURANDORELA","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥ 18 years\n* Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.\n* Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.\n* Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria\n* World Health Organization (WHO) performance Status 0 or 1.\n* Urothelial cancer is the dominant histology (\\>50%). Any component of small cell or adenocarcinoma is not allowed.\n* Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Platelets ≥100 x109\u002FL, Hemoglobin ≥5.5 mmol\u002FL, GFR\\>30 ml\u002Fmin, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN\n* Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.\n* Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)\n\nExclusion Criteria:\n\n* Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.\n* Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).\n* Previous intravenous systemic therapy or radiotherapy for UC.\n* Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.\n* Prior CTLA-4, LAG3 or PD-1\u002FPD-L1-targeting immunotherapy.\n* Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n* HIV-positive patients are eligible if the following applies:\n* No AIDS defining opportunistic infection within the last year and a current CD4 count \\>350 cells\u002FuL.\n* Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study\n* CD4 counts and viral load are monitored per standard of care by a local health care provider\n* In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.\n* Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.\n* Use of other investigational drugs before study drug administration.\n* Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated \\>10%). 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.\n* Pregnant and lactating female patients.\n* Major 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 diagnosis.\n* Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina.",{"count":233,"type":19},90,[84],"This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment",[148,26,237,150,204,238,205,239,178,240,241],"Neoplasms by Site","Female Urogenital Diseases and Pregnancy Complications","Urinary Bladder Diseases","Urinary Bladder Neoplasm","Antineoplastics Toxicity",[243,244],"Nivolumab","Relatlimab","2025-09-01",{"date":247,"type":39},"2025-09-03",{"date":249,"type":39},"2024-02-19",{"date":251,"type":19},"2028-08-01",{"name":190,"class":133},9,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":58,"phases":264,"briefSummary":265,"conditions":266,"keywords":275,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":121},"100484789","phase-1-a-study-of-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-star0602-in-participants-with-advanced-solid-tumors-100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H\n   2. MSI-H\u002FdMMR\n   3. CRC (both Ras wild type and mutant)\n   4. Virally associated tumors\n   5. Metastatic triple negative breast cancer\n   6. Platinum-resistant epithelial ovarian cancer\n   7. Metastatic castration-resistance prostate cancer\n   8. Primary stage IV or recurrent non-small cell lung cancer\n   9. Immunogenic solid tumors\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.",{"count":263,"type":19},365,[60,84],"This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.",[267,268,26,269,237,270,271,208,150,272,273,274],"Advanced Solid Tumors","Genital Neoplasm, Female","Lung Neoplasm","Papillomavirus Infection","Epstein-Barr Virus Infections","Vulvar Neoplasms","Vulvar Diseases","Abdominal Neoplasm",[267,276,277,211,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,24],"STAR0602","Intravenous","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immunotherapy","Immune Checkpoint Inhibitor Resistance","Head and Neck Cancer","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Small Cell Lung Cancer","Biliary Cancer","Melanoma","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Endometrial Cancer","Colorectal Cancer","Small Bowel Cancer","Cervical Cancer","Gastrointestinal Neoplasms","Gastric Cancer","Esophageal Cancer","2025-07-07",{"date":305,"type":39},"2025-07-09",{"date":307,"type":39},"2023-01-04",{"date":309,"type":19},"2026-10",{"name":311,"class":110},"Marengo Therapeutics, Inc.",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":80,"minAge":16,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":58,"phases":321,"briefSummary":323,"conditions":324,"keywords":330,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":47},"100570413","phase-4-18f-fluciclovine-petct-impact-on-predicting-clinical-outcome-of-177lu-psma-617-therapy-in-patients-with-prostate-cancer-100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.",{"count":320,"type":19},15,[322],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[90,325,326,178,91,327,328,150,237,26,329],"Prostatic Neoplasms, Castration-Resistant","Metastatic Prostate Cancer","Urogenital Diseases, Male","Genital Diseases, Male","Genital Neoplasms, Male",[94,331,332,333,334],"PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","2024-11-26",{"date":160,"type":39},{"date":338,"type":19},"2024-12-15",{"date":340,"type":19},"2027-11-01",{"name":342,"class":343},"VA Greater Los Angeles Healthcare System","FED",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":351,"minAge":16,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":58,"phases":354,"briefSummary":355,"conditions":356,"keywords":364,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":47},"100402352","phase-2-pembrolizumab-and-lenvatinib-for-platinum--sensitive-recurrent-ovarian-cancer-100402352","NCT04519151","Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer","A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Female participants who are at least 18 years of age on the day of signing informed consent, with histologically-confirmed diagnosis of EOC (except from low grade tumors and mucinous histology).\n2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive during the treatment period and for at least 120 days after the last dose of study treatment.\n3. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n4. Have measurable disease at baseline based on RECIST 1.1. Lesions\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Have received a front-line platinum-based regimen per local standard of care or treatment guideline following the primary or interval debunking surgery with radiologically documented disease recurrence no earlier than 6 months following completion of platinum-based therapy.\n\nNote: Maintenance treatment following front-line treatment is permitted and counted together as part of the front-line treatment. Recurrence is evaluated since last platinum-based chemotherapy administration (for patients treated with maintenance bevacizumab or PARP inhibitors) Note: Patients that received maintenance immune checkpoint inhibitors will be eligible if progression was documented over 6 months since completion of the immunotherapy maintenance treatment.\n\nHave received 0 to 1 line of chemotherapy for ROC (or 1 to 2 total prior lines counting the front line) and must have a PFI (or treatment-free interval) of \\>6 months for each treatment line.\n\n8\\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\n\n9\\. Have adequately controlled blood pressure (BP) with or without antihypertensive medications 10. Have adequate organ function as defined by blood tests.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test\n2. The participant is pregnant or breastfeeding at Screening or Baseline, or is expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n3. The participant has received prior therapy with an anti-PD-1, anti-PD-L1 oranti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) in the last 6 months (6 months are calculated from the last dose until study initiation).\n4. The participant has received prior systemic anti-cancer therapy mAb, chemotherapy or targeted small molecule therapy within 4 weeks prior to the planned first dose of the study, including investigational agents within 4 weeks. For tyrosine kinase inhibitors (TKIs), other than lenvatinib, and hormonal therapy a shorter interval of 5 half-lives is allowed between prior therapy and study treatment initiation.\n\n   Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.\n5. The participant has received prior lenvatinib.\n6. The participant has received prior radiotherapy within 2 weeks of start of study treatment.\n7. The patient had prior grade 3 immune related toxicity due to immune checkpoint inhibitors or non-infectious pneumonitis.\n8. The participant has received more than 2 prior chemotherapy lines.\n9. The participant has a history of tumor bleeding one month before study enrollment.\n10. The participant has received a live vaccine within 30 days prior to the first dose of study drug.\n11. The participant is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n    Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n12. The participant 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.\n\n    Note: The use of physiologic doses of corticosteroids is allowed.\n13. The participant has a known active second\u002Fadditional malignancy that is progressing or has required active treatment within the past 5 years Note: Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer.\n14. The participant has a known active CNS metastases and\u002For carcinomatous meningitis.\n\n    Note: Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n15. The participant has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of excipients.\n16. The participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n17. The participant has an active infection requiring systemic therapy.\n18. The participant has a known history of human immunodeficiency virus (HIV 1\u002F2 antibodies).\n19. The participant has a known history of hepatitis B or known active hepatitis C virus\n20. The participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n21. The participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n22. The participant has had an active allogenic tissue\u002Fsolid organ transplant.\n23. The participant has uncontrolled blood pressure\n24. The participant has clinically significant electrolyte abnormalities that have not been corrected.\n25. The participant has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) within 6 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability requiring medical treatment at Screening.\n26. The participant has bleeding or thrombotic disorders, radiographic evidence of major blood vessel invasion\u002Finfiltration, or is at risk for severe hemorrhage.\n\n    Note: The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n27. The participant has \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n28. Prolongation of QTc interval to \\>480 ms.\n29. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n30. The participant has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n31. The participant has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.\n32. The participant has a known intolerance to the study treatment (or any of its excipients).","FEMALE",{"count":353,"type":19},24,[84],"This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.",[357,358,359,360,361,362,26,363],"Ovarian Neoplasms","Carcinoma, Ovarian Epithelial","Neoplasm of Stomach","Ovarian Diseases","Genital Neoplasms, Female","Ovarian Epithelial Tumor","Neoplasms, Glandular and Epithelial",[365,366,367,150,368],"Ovarian Cancer","Platinum sensitive","Ovarian Epithelial","Genital Neoplasms","2023-06-06",{"date":371,"type":39},"2023-06-08",{"date":373,"type":39},"2021-04-12",{"date":375,"type":19},"2029-11",{"name":377,"class":378},"Sheba Medical Center","OTHER_GOV"]