[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-medullary-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-medullary-carcinoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100528496","phase-2-sacituzumab-govitecan-with-or-without-atezolizumab-immunotherapy-in-rare-genitourinary-tumors-smart-such-as-high-grade-neuroendocrine-carcinomas-adenocarcinoma-and-squamous-cell-bladderurinary-tract-cancer-renal-medullary-carcinoma-and-penile-c-100528496",false,"NCT06161532","Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder\u002FUrinary Tract Cancer, Renal Medullary Carcinoma and Penile C...","A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder\u002FUrinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer","* INCLUSION CRITERIA:\n* Participants must have histologically confirmed diagnosis of a locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor of the following histologies:\n\n  * HGNEC, including, but not limited to, small cell carcinoma and large cell neuroendocrine carcinoma of the bladder or urinary tract\n  * Squamous cell carcinoma of the bladder or urinary tract\n  * Primary adenocarcinoma of the bladder or urinary tract (urachal or non-urachal)\n  * Renal medullary carcinoma\n  * Squamous cell carcinoma of the penis\n\nNote: For the purposes of enrollment, the urinary tract is defined as the renal pelvis, ureter, bladder, and urethra.\n\n* Pre-study treatment tissue availability (sufficient tissue for approximately 25 unstained slides is mandatory for enrollment. If tissue is determined to be insufficient\u002Funsuitable, a fresh biopsy prior to study therapy will be required.\n* Locally advanced unresectable or metastatic disease. Participants who have received prior treatment must have evidence of progressive disease (PD; i.e., defined as new or progressive lesions evident on cross-sectional imaging).\n* Prior treatment as follows:\n\n  * Cohort A: Participants must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs.\n  * For Cohort B: Participants must be ICI naive but eligible to receive them.\n* Participants must have measurable disease, per RECIST 1.1.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 1 (Karnofsky \\>= 70%.\n* Adequate organ and marrow function as defined below:\n\n  * Hemoglobin (Hgb) \\>= 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL\n  * Platelets \\>= 100,000\u002FmcL\n  * Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN) (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * AST\u002F ALT \\\u003C= 2.5 x ULN (or \\\u003C= 5 x ULN if considered to be related to liver metastases by the PI)\n  * Serum creatinine \\\u003C= 2 x ULN or creatinine clearance \\>= 30 ml\u002Fmin\u002F1.73 m\\^2 (glomerular filtration rate \\[GFR\\] may be used in place of CrCl. Creatinine clearance or eGFR should be calculated per institutional standard)\n  * Alkaline phosphatase \\\u003C= 2.5 x ULN (or \\\u003C= 5 x ULN if considered to be related to liver or bone metastases by the PI)\n  * Serum albumin \\>= 25g\u002FL\n  * For participants not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x ULN\n  * For participants receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Participants may have received any number of prior anti-cancer treatments or be treatment na(SqrRoot) ve (except for participants with HGNEC of the bladder\u002Furinary tract cancer, whom must have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment in the locally advanced\u002Fmetastatic setting).\n* Treated central nervous system (CNS) lesions, provided that all of the following criteria are met:\n\n  * Measurable disease, per RECIST v1.1, must be present outside the CNS.\n  * The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.\n  * The participant has not undergone stereotactic radiotherapy within 1 week prior to initiation of study treatment, whole-brain radiotherapy (WBXRT) within 2 weeks prior to initiation of study treatment, or neurosurgical resection within 4 weeks prior to initiation of study treatment.\n  * The participant has no ongoing requirement for corticosteroids as therapy for CNS disease.\n  * The participant may be receiving anti-convulsant therapy if appropriate and the dose is considered stable.\n\nPrior treatment as follows:\n\n* Prior radionuclide treatment must have a washout period of at least 6 weeks prior to the first dose of study treatment.\n* Prior treatment with chemotherapy must have a washout period of 2 weeks prior to the first dose of study treatment.\n* Prior treatment with non-CNS-directed radiotherapy must have a washout period of 2 weeks prior to the first dose of study treatment (except palliative bone-directed radiotherapy which does not require any washout).\n* Prior treatment with a small molecule kinase inhibitor must have a washout period of at least 2 weeks or five half-lives of the compound or active metabolites, prior to the first dose of study treatment.\n* Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) must have a washout period of at least 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study treatment.\n* Major surgical procedure, other than for diagnosis, must not occur within 4 weeks prior to the first dose of study treatment.\n* Prior treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) must have a washout period of at least 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  * Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) are allowed to be continued where in the opinion of the treating investigator stopping such therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by the treating investigator prior to enrollment and hormonal agents that inhibit or induce UGT1A1 will be excluded while on trial.\n* Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a CD4 count \\>= 200 cells\u002FmicroL, and an undetectable viral load.\n* Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate guidance. For previously treated patients or those with prior infection that has been cleared, prophylaxis is permitted, and hepatology consultation recommended.\n* Participants with a history of hepatitis C virus (HCV) infection (i.e., positive HCV antibody test) must have been treated and cured (negative HCV RNA test at screening). Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.\n* Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use an effective method of contraception as follows:\n\n  * IOCBP must agree to use one (1) highly effective methods of contraception (e.g., intrauterine device \\[IUD\\], hormonal, surgical sterilization) prior to study entry, for the duration of study participation, and for up to 6 months after discontinuation of the study drug(s). Participants must refrain from donating eggs during this same period.\n  * Individuals able to father children must agree to use an effective method of contraception (barrier, surgical sterilization) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s) and must refrain from donating sperm during this same period.\n* Nursing participants must discontinue nursing and\u002For not begin nursing until 1 month after the last dose of study drug(s).\n* Ability of participants to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38, irinotecan, or atezolizumab, or hypersensitivity to Chinese hamster ovary cell products.\n* Symptomatic or untreated brain\u002FCNS metastases.\n* Positive serum or urine Beta-human chorionic gonadotropin (Beta-hCG) test at screening.\n* Participants unwilling to accept blood products as medically indicated.\n* For Cohort B: Active or history of autoimmune disease or immune deficiency that might recur, which might affect vital organ function or require immune suppressive treatment including systemic corticosteroids, when receiving atezolizumab. These conditions include myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area.\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n    * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Anticipation of need for a major surgical procedure during the study.\n* Prior allogeneic stem cell or solid organ transplantation.\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG or atezolizumab treatment or within 5 months after the final dose of SG or atezolizumab. Note: Seasonal flu vaccines that do not contain a live virus and locally authorized\u002Fapproved COVID-19 vaccines are permitted.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) with the exception of participants with indwelling catheters (e.g., PleurX(R)) who are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN).\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment.\n* Prior treatment with immune checkpoint blockade therapies, including anti-PD-1, and anti-PD-L1 therapeutic antibodies (for Arm 2 only).\n* Participants with prior malignancy within the previous 2 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or low risk Gleason 6 prostate cancer, among others. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for the study.\n* History of leptomeningeal disease\n* Active tuberculosis\n* Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.","ALL","18 Years","120 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nRare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU.\n\nObjective:\n\nTo test SG, either alone or combined with atezolizumab, in people with rare GU tumors.\n\nEligibility:\n\nAdults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor.\n\nBoth SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm.\n\nAll participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle.\n\nBlood and urine tests, imaging scans, and other exams will be repeated during study visits.\n\nTreatment may continue for up to 5 years.\n\nFollow-up visits will continue for 5 more years.",[27,28,29,30,31,32,33,34],"Small Cell Carcinoma of the Bladder","Small Cell Carcinoma of the Urinary Tract","Squamous Cell Carcinoma of the Bladder","Squamous Cell Carcinoma of the Urinary Tract","Primary Adenocarcinoma of the Bladder","Primary Adenocarcinoma of the Urinary Tract","Renal Medullary Carcinoma","Squamous Cell Carcinoma of the Penis",[36,37,38,39,40],"Urothelial carcinoma","Trophoblastic cell surface antigen 2","Programmed death-ligand 1","SN-38","Immunotherapy","RECRUITING","2026-07-01",{"date":44,"type":45},"2026-07-02","ACTUAL",{"date":47,"type":45},"2024-08-01",{"date":49,"type":21},"2028-11-01",{"name":51,"class":52},"National Cancer Institute (NCI)","NIH",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":53},"100550269","phase-2-phase-ii-trial-of-ubamatamab-alone-or-in-combination-with-cemiplimab-in-muc16-expressing-smarcb1-deficient-malignancies-100550269","NCT06444880","Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies","Inclusion Criteria:\n\n1. Participants with locally advanced or metastatic RMC (RMC cohort) or ES (ES cohort) histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible for the RMC cohort.\n2. Eligible participants should either demonstrate serum CA-125 levels ≥ 70 units\u002Fml during screening or positive H score of \\>25 for MUC16 (CA-125) by IHC in tumor tissues collected within 12 months from screening as noted in participant EMR:\n\n   1. The H score is calculated using the standard formula commonly used in IHC: H score = \\[(0 x % negative cells) + (1 x % weak positive cells) + (2 x % moderate positive cells) + (3 x % strong positive cells). For instance, if 50% of tumor cells show weak staining, 30% of tumor cells show moderate staining, and 20% of cells show strong staining, the H-score would be: (50×1)+(30×2)+(20×3)=50+60+60=170.\n   2. If serum CA-125 ≥ 70 units\u002Fml then participants will be enrolled without delay. IHC for MUC16 will be used as a correlative biomarker but not for trial eligibility.\n   3. If serum CA-125 \\\u003C 70 units\u002Fml then for trial eligibility, MUC16 expression should be checked by IHC in tumor tissues collected within 12 months from screening:\n\n   i. If H score is \\\u003C 25 then the patient will not be eligible for the trial ii. If H score ≥ 25 then the patient will be eligible for the trial\n3. Participants will be eligible in the RMC cohort regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.\n4. Participants must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures ≥ 15 mm with conventional techniques or ≥ 10 mm with more sensitive techniques such as MRI or CT scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.\n5. Participants must have progressed on at least one line of prior therapy.\n6. There must be evidence of progression on or after last treatment regimen received.\n7. ECOG performance status 0-1\n\n   a. NOTE: If participant is unable to walk due to paralysis, but is mobile in a wheelchair, participant is considered to be ambulatory for the purpose of assessing their performance status.\n8. Age (at the time of consent\u002Fassent): ≥ 18 years\n\n   a. RMC is the third most common renal cell carcinoma in children and young adults in the United States21 and while we will initially enroll participants aged ≥18 years old, we will in coordination with Regeneron consider allowing pediatric participants ≥12 years old if no trial limiting toxicities (TOX), as defined in Section 9.1.2., after the interim analysis of the first 10 participants enrolled and based on the accumulated pharmacokinetic \u002F pharmacodynamic data of ubamatamab in this population at that time. If these criteria are fulfilled, then adolescent participants age 12 years and older will be allowed with signed assent and parental consent according to institutional guidelines and requirements, as long as their weight is \\>40 kg given that this is the lower weight limit for which safety following ubamatamab with or without cemiplimab exposure has been ascertained.\n9. Consent to MD Anderson companion laboratory protocol 2014-0938\n10. Participants must have adequate organ and marrow function as defined below:\n\n    Hemoglobina ≥ 9 g\u002Fdl (treatment allowed) Absolute neutrophil countb ≥ 1,000\u002FµL Platelets ≥ 75,000\u002FµL Total bilirubin ≤ 1.5 mg\u002Fdl AST(SGOT) or ALT (SGPT) ≤ 2.5 X institutional ULN, except in known hepatic metastasis, wherein may be ≤ 5 x ULN Serum Creatininec ≤ 1.5 x ULN by gender (as long as patient does not require dialysis)\n\n    a May receive transfusion within the screening period b Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days c If creatinine is not \\\u003C1.5×ULN, then calculate by Cockcroft-Gault methods or local institutional standard and CrCl must be \\>30 mL\u002Fkg\u002F1.73 m2\n11. Participants with controlled brain metastases are allowed on protocol if the brain metastases were surgically resected or treated with radiosurgery or Gamma knife, without recurrence or edema for 1 month (4 weeks). Participants actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible.\n12. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of the study drug.\n13. Women must not be breastfeeding.\n14. WOCBP must agree to follow instructions for method(s) of contraception from the time of registration for treatment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion. Men must agree to effective contraception from the time of registration for treatment to 7 months post last protocol treatment.\n\n    Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male participants who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \\\u003C 1% per year when used consistently and correctly.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Patient\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of ubamatamab\u002Fcemiplimab administration.\n\n    The effects of ubamatamab\u002Fcemiplimab on the developing human fetus are unknown. For this reason and because immunotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death\n2. Participants previously treated with T-cell-redirecting bispecific antibodies or MUC16-targeted therapies (including vaccines) are excluded. Participants who received CAR-T therapies within 30 days of first dose of study drug are also excluded. However, participants previously treated with immune checkpoint therapies such as anti-PD1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 immune checkpoint inhibitors are eligible, as long as they have been off these therapies for at least 60 days (\\~3 half-lives) prior to initiation of study treatment with ubamatamab.\n3. Participants currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapies such as tazemetostat) within 2 weeks (14 days) prior to study Day 1 are excluded. Participants who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination immunotherapy are eligible.\n4. Participants with persistent grade ≥2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse events due to ubamatamab and\u002For cemiplimab or otherwise hinder patient participation in the clinical trial.\n5. Participants, who have had a major surgery or significant traumatic injury (injury requiring \\> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, participants who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).\n6. Participants who have organ allografts.\n7. Known or suspected autoimmune disease. Participants with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], Systemic Lupus Erythematosus or autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\] are excluded from this study. Participants with a history of Hashimoto's thyroiditis only requiring hormone replacement, Type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.\n8. Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency.\n\n   1. Participants with HIV who have controlled infection (undetectable viral load with the exception of clinically insignificant blips and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.\n   2. Participants with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.\n   3. Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: Serum HBV DNA PCR should be tested and if it is above the limit of detection at screening then antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed every 12 months +\u002F- 3 months.\n   4. Participants who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n9. Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting. Patients with active COVID-19 disease as indicated by a positive polymerase reaction (PCR) test are excluded. Participants with previous COVID-19 disease are allowed if ≥30 days from last positive test, and COVID-19 symptoms have resolved and\u002For PCR test is now negative.\n10. Participants must not be scheduled to receive another experimental drug while on this study.\n11. Participants who are on high dose steroid (e.g., \\> 10mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g., infliximab). Topical, inhaled, intra-articular, ocular, or intranasal corticosteroids (with minimal systemic absorption) are allowed. A brief course (\\\u003C48 hours) of systemic corticosteroids for prophylaxis (eg, from contrast dye allergy) is permitted. Physiological corticosteroid replacement therapy for adrenal insufficiency (up to hydrocortisone 30 mg \u002F daily or equivalent) is also permitted.\n12. Left ventricular ejection fraction (LVEF) assessment with documented LVEF \\\u003C 50% by transthoracic echocardiogram (TTE) within 6 months prior to start of study treatment. In cases of LVEF 45-50% in absence of clinical symptoms, after review and clearance by cardiologist, the patient may be enrolled.\n13. Active myocarditis, regardless of etiology.\n14. Moderate to large pericardial effusion (eg, \\> approximately 100 mL) as measured by echocardiogram at baseline. Multigated acquisition (MUGA) is not sufficient for evaluating pericardial effusion.\n15. Has a history of any clinically significant arrhythmia including atrial fibrillation or implantation of a pacemaker or defibrillator.\n16. Participants who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\n\n    1. Symptomatic congestive heart failure of New York heart Association Class III or IV\n    2. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\n    3. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.\n    4. Participants with a history of major psychiatric illness judged unable to fully understand the investigational nature of the study and the risks associated with the therapy.\n17. Participants must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ubamatamab or cemiplimab or that might affect the interpretation of the results of the study or render the participant at high risk from treatment complications.\n18. Participants should not receive immunization with attenuated live vaccines within 30 days of planned start of study medication.\n\n    a. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n19. Female participants who are pregnant or breast feeding, or adults of reproductive potential who are not willing to use effective birth control methods as defined above.\n20. Any participants who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.\n21. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ubamatamab or cemiplimab.\n22. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","12 Years",{"count":62,"type":21},40,[24],"To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).",[66,67,33],"SMARCB1-Deficient Malignancies","Epithelioid Sarcoma","2026-06-16",{"date":70,"type":45},"2026-06-18",{"date":72,"type":45},"2024-10-09",{"date":74,"type":21},"2028-07-31",{"name":76,"class":77},"M.D. Anderson Cancer Center","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":53},"100539340","phase-2-pembrolizumab-plus-enfortumab-vedotin-in-collecting-duct-and-renal-medullary-carcinoma-100539340","NCT06302569","Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma","Activity of Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma","REPRINT","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma will be enrolled in this study.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Have confirmed histology diagnosis of Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma by central pathology review.\n* 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.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n* Have adequate organ function as defined in the following table (Table 4). Specimens must be collected within 10 days prior to the start of study intervention.\n* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\nHepatitis B screening tests are not required unless:\n\n1. Known history of HBV infection\n2. As mandated by local health authority\n\n   * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nHepatitis C screening tests are not required unless:\n\na) Known history of HCV infection b) As mandated by local health authority\n\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study\n  5. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)\n\n     Exclusion Criteria:\n* 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).\n* Has received prior systemic anti-cancer therapy, including investigational agents, within 2 weeks prior to treatment allocation.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS diseases permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n* 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.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* 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* Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: 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. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. 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 intervention.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* 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.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":87,"type":21},23,[24],"This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.\n\nApproximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.\n\nPatients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.\n\nThe study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes.",[91,92,33],"Bellini Carcinoma","Collecting Duct Carcinoma",[94,95,96,92,33],"Pembrolizumab","Enfortumab Vedotin","Non-clear cell renal cell carcinoma","2025-09-02",{"date":99,"type":45},"2025-09-09",{"date":101,"type":45},"2025-05-30",{"date":103,"type":21},"2029-05",{"name":105,"class":77},"Giuseppe Procopio"]