[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03564340":3,"trial-entities:NCT03564340":585,"trial-summary:NCT03564340":592},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":31,"interventions":34,"primary_outcomes":63,"secondary_outcomes":97,"sex":200,"minimum_age":201,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":202,"std_ages":206,"locations":209,"central_contacts":569,"overall_officials":575,"references":579,"see_also_links":584},"NCT03564340","R4018-ONC-1721","Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers","A Phase 1\u002F2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers","RECRUITING","2027-05-10","2026-07","2026-07-22","2018-05-21","Regeneron Pharmaceuticals","INDUSTRY",false,"The main purpose of this study is to:\n\n* Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus\n* The study will also look at the levels of ubamatamab and\u002For cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics\n* The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus\n* To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)",null,[19,20,21,22,23,24],"Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Recurrent Primary Peritoneal Cancer","Recurrent Endometrial Cancer","Endometrial Cancer","Low-grade Serous Ovarian Cancer",[],"INTERVENTIONAL","TREATMENT",[29,30],"PHASE1","PHASE2",{"count":32,"type":33},890,"ESTIMATED",[35,44,50,57],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":42},"DRUG","Ubamatamab","Administered per the protocol",[40,41],"Combination Therapy","Monotherapy",[43],"REGN4018",{"type":36,"name":45,"description":38,"armGroupLabels":46,"otherNames":47},"Cemiplimab",[40],[48,49],"REGN2810","Libtayo®",{"type":36,"name":51,"description":38,"armGroupLabels":52,"otherNames":53},"Sarilumab",[41],[54,55,56],"Kevzara®","REGN88","SAR153191",{"type":36,"name":58,"description":38,"armGroupLabels":59,"otherNames":60},"Tocilizumab",[41],[61,62],"ACTEMRA®","Biosimilar",[64,68,71,74,76,78,80,82,84,86,88,90,92,95],{"measure":65,"description":66,"timeFrame":67},"Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy","Dose Escalation Phase","From Cycle 1, Day 1 up to 35 days",{"measure":69,"description":66,"timeFrame":70},"Number of participants with DLTs for ubamatamab with cemiplimab","From Cycle 2, Day 1 up to 21 days",{"measure":72,"description":66,"timeFrame":73},"Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy","Up to 2 years",{"measure":75,"description":66,"timeFrame":73},"Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab",{"measure":77,"description":66,"timeFrame":73},"Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy",{"measure":79,"description":66,"timeFrame":73},"Number of participants with SAEs for ubamatamab with cemiplimab",{"measure":81,"description":66,"timeFrame":73},"Number of deaths for ubamatamab monotherapy",{"measure":83,"description":66,"timeFrame":73},"Number of deaths for ubamatamab with cemiplimab",{"measure":85,"description":66,"timeFrame":73},"Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy",{"measure":87,"description":66,"timeFrame":73},"Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab",{"measure":89,"description":66,"timeFrame":73},"Concentration of ubamatamab in serum over time for ubamatamab monotherapy",{"measure":91,"description":66,"timeFrame":73},"Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab",{"measure":93,"description":94,"timeFrame":73},"Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy","Dose Expansion Phase",{"measure":96,"description":94,"timeFrame":73},"ORR defined by RECIST 1.1 for ubamatamab with cemiplimab",[98,100,102,104,105,107,108,109,110,112,113,114,115,119,121,123,125,128,131,133,135,137,139,141,143,145,147,150,152,154,156,158,160,162,164,166,168,170,172,174,176,178,180,182,184,186,188,190,192,194,196,198],{"measure":99,"description":66,"timeFrame":73},"ORR based on RECIST 1.1 for ubamatamab monotherapy",{"measure":101,"description":66,"timeFrame":73},"ORR based on RECIST 1.1 for ubamatamab with cemiplimab",{"measure":103,"description":94,"timeFrame":73},"Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy",{"measure":75,"description":94,"timeFrame":73},{"measure":106,"description":94,"timeFrame":73},"Number of participants with SAEs for ubamatamab monotherapy",{"measure":79,"description":94,"timeFrame":73},{"measure":81,"description":94,"timeFrame":73},{"measure":83,"description":94,"timeFrame":73},{"measure":111,"description":94,"timeFrame":73},"Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab monotherapy",{"measure":87,"description":94,"timeFrame":73},{"measure":89,"description":94,"timeFrame":73},{"measure":91,"description":94,"timeFrame":73},{"measure":116,"description":117,"timeFrame":118},"Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS\u002FQoL score for ubamatamab monotherapy","Dose Expansion Phase\n\nThe EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status\u002Fquality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as \"not at all\" and 4 as \"very much.\"","Baseline up to 2 years",{"measure":120,"description":94,"timeFrame":118},"Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS\u002FQoL score for ubamatamab with cemiplimab",{"measure":122,"description":94,"timeFrame":118},"Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab monotherapy",{"measure":124,"description":94,"timeFrame":118},"Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab with cemiplimab",{"measure":126,"description":127,"timeFrame":118},"Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for ubamatamab monotherapy","Dose Expansion Phase excluding the Endometrial Cancer Cohort\n\nThe MOST-24 is a 24-item questionnaire used to measure the impact of chemotherapy on symptoms (21 items) and well-being (3 items). The expected questionnaire completion time is less than 5 minutes.\n\nThe prevalence of each MOST item at assessment time points can be summarized by providing the mean, standard deviation and proportions based on the MOST response format, a numeric rating scale with integers from zero to 10, with five verbal anchors: 'No trouble at all' (0), 'Mild' (1-3), 'Moderate' (4-6), 'Severe' (7-10), and 'Worst I can imagine' (10).",{"measure":129,"description":130,"timeFrame":118},"Change from baseline in abdominal symptoms as measured by the MOST-Abdominal index score for ubamatamab with cemiplimab","Dose Expansion Phase Not applicable to Endometrial Cancer Cohort",{"measure":132,"description":94,"timeFrame":73},"Time to deterioration in GHS\u002FQoL for ubamatamab monotherapy",{"measure":134,"description":94,"timeFrame":73},"Time to deterioration in GHS\u002FQoL for ubamatamab with cemiplimab",{"measure":136,"description":94,"timeFrame":73},"Time to deterioration in physical functioning for ubamatamab monotherapy",{"measure":138,"description":94,"timeFrame":73},"Time to deterioration in physical functioning for ubamatamab with cemiplimab",{"measure":140,"description":94,"timeFrame":73},"Time to deterioration in abdominal symptoms for ubamatamab monotherapy",{"measure":142,"description":94,"timeFrame":73},"Time to deterioration in abdominal symptoms for ubamatamab with cemiplimab",{"measure":144,"description":94,"timeFrame":118},"Change from baseline in QoL as measured by EQ-5D for ubamatamab monotherapy",{"measure":146,"description":94,"timeFrame":118},"Change from baseline in QoL as measured by EQ-5D for ubamatamab with cemiplimab",{"measure":148,"description":149,"timeFrame":73},"ORR based on iRECIST for ubamatamab monotherapy","Dose Escalation and Dose Expansion Phases",{"measure":151,"description":149,"timeFrame":73},"ORR based on iRECIST for ubamatamab with cemiplimab",{"measure":153,"description":149,"timeFrame":73},"Best overall response (BOR) based on RECIST 1.1 for ubamatamab monotherapy",{"measure":155,"description":149,"timeFrame":73},"BOR based on iRECIST for ubamatamab monotherapy",{"measure":157,"description":149,"timeFrame":73},"BOR based on RECIST 1.1 for ubamatamab with cemiplimab",{"measure":159,"description":149,"timeFrame":73},"BOR based on iRECIST for ubamatamab with cemiplimab",{"measure":161,"description":149,"timeFrame":73},"Duration of response (DOR) based on RECIST 1.1 for ubamatamab monotherapy",{"measure":163,"description":149,"timeFrame":73},"DOR based on iRECIST for ubamatamab monotherapy",{"measure":165,"description":149,"timeFrame":73},"DOR based on RECIST 1.1 for ubamatamab with cemiplimab",{"measure":167,"description":149,"timeFrame":73},"DOR based on iRECIST for ubamatamab with cemiplimab",{"measure":169,"description":149,"timeFrame":73},"Disease control rate based on RECIST 1.1 for ubamatamab monotherapy",{"measure":171,"description":149,"timeFrame":73},"Disease control rate based on iRECIST for ubamatamab monotherapy",{"measure":173,"description":149,"timeFrame":73},"Disease control rate based on RECIST 1.1 for ubamatamab with cemiplimab",{"measure":175,"description":149,"timeFrame":73},"Disease control rate based on iRECIST for ubamatamab with cemiplimab",{"measure":177,"description":149,"timeFrame":73},"Complete response (CR) rate based on RECIST 1.1 for ubamatamab monotherapy",{"measure":179,"description":149,"timeFrame":73},"CR rate based on iRECIST 1.1 for ubamatamab monotherapy",{"measure":181,"description":149,"timeFrame":73},"CR rate based on RECIST 1.1 for ubamatamab with cemiplimab",{"measure":183,"description":149,"timeFrame":73},"CR rate based on iRECIST 1.1 for ubamatamab with cemiplimab",{"measure":185,"description":149,"timeFrame":73},"Progression-free survival (PFS) based on RECIST 1.1 for ubamatamab monotherapy",{"measure":187,"description":149,"timeFrame":73},"PFS based on iRECIST for ubamatamab monotherapy",{"measure":189,"description":149,"timeFrame":73},"PFS based on RECIST 1.1 for ubamatamab with cemiplimab",{"measure":191,"description":149,"timeFrame":73},"PFS based on iRECIST for ubamatamab with cemiplimab",{"measure":193,"description":149,"timeFrame":73},"Cancer antigen-125 (CA-125) response for ubamatamab monotherapy",{"measure":195,"description":149,"timeFrame":73},"CA-125 response for ubamatamab with cemiplimab",{"measure":197,"description":149,"timeFrame":73},"Presence or absence of anti-drug antibodies against ubamatamab",{"measure":199,"description":149,"timeFrame":73},"Presence or absence of anti-drug antibodies against cemiplimab","FEMALE","18 Years",{"inclusion":203,"exclusion":204,"raw_text":205},[],[],"Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:\n\n   1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)\n   2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)\n   3. documented relapse or progression on or after the most recent line of therapy\n   4. no standard therapy options likely to convey clinical benefit\n2. Adequate organ and bone marrow function as defined in the protocol\n3. Life expectancy of at least 3 months\n4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.\n5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:\n\n   1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol\n   2. 1-4 prior lines of systemic therapy, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Prior treatment with anti-Programmed Cell Death (PD-1)\u002FPD-L1 therapy, as described in the protocol\n2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)\n3. Prior treatment with a MUC16 - targeted therapy\n4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol\n5. History and\u002For current cardiovascular disease, as defined in the protocol\n6. Severe and\u002For uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen\n\nNote: Other protocol-defined Inclusion\u002FExclusion Criteria apply",[207,208],"ADULT","OLDER_ADULT",[210,219,227,231,239,248,254,258,266,274,283,291,300,307,316,324,331,340,348,356,364,372,380,388,395,402,411,418,424,431,440,448,455,463,467,471,475,479,488,495,502,506,513,517,520,527,536,544,547,554,558,562],{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":215,"geoPoint":216},"University of Alabama_6th Ave","Birmingham","Alabama","35294","United States",{"lat":217,"lon":218},33.52066,-86.80249,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":215,"geoPoint":224},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":225,"lon":226},42.35843,-71.05977,{"facility":228,"status":8,"city":221,"state":222,"zip":229,"country":215,"geoPoint":230},"Dana Farber \u002F Harvard Cancer Center","02215",{"lat":225,"lon":226},{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":215,"geoPoint":236},"Mayo Clinic - Rochester","Rochester","Minnesota","55901",{"lat":237,"lon":238},44.02163,-92.4699,{"facility":240,"status":241,"city":242,"state":243,"zip":244,"country":215,"geoPoint":245},"Roswell Park Cancer Institute","WITHDRAWN","Buffalo","New York","14263",{"lat":246,"lon":247},42.88645,-78.87837,{"facility":249,"status":8,"city":243,"state":243,"zip":250,"country":215,"geoPoint":251},"Columbia University Medical Center","10032",{"lat":252,"lon":253},40.71427,-74.00597,{"facility":255,"status":8,"city":243,"state":243,"zip":256,"country":215,"geoPoint":257},"Memorial Sloan Kettering Cancer Center","10065",{"lat":252,"lon":253},{"facility":259,"status":8,"city":260,"state":261,"zip":262,"country":215,"geoPoint":263},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"lat":264,"lon":265},39.96118,-82.99879,{"facility":267,"status":8,"city":268,"state":269,"zip":270,"country":215,"geoPoint":271},"Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"lat":272,"lon":273},35.46756,-97.51643,{"facility":275,"status":276,"city":277,"state":278,"zip":279,"country":215,"geoPoint":280},"Sarah Cannon Research Institute","COMPLETED","Nashville","Tennessee","37203",{"lat":281,"lon":282},36.16589,-86.78444,{"facility":284,"status":8,"city":285,"state":286,"zip":287,"country":215,"geoPoint":288},"Virginia Commonwealth University","Richmond","Virginia","23219",{"lat":289,"lon":290},37.55376,-77.46026,{"facility":292,"status":276,"city":293,"state":294,"zip":295,"country":296,"geoPoint":297},"Prince of Wales Hospital","Randwick","New South Wales","2031","Australia",{"lat":298,"lon":299},-33.91439,151.24895,{"facility":301,"status":276,"city":302,"zip":303,"country":296,"geoPoint":304},"Peter MacCallum Cancer Center","Melbourne","3000",{"lat":305,"lon":306},-37.814,144.96332,{"facility":308,"status":8,"city":309,"state":310,"zip":311,"country":312,"geoPoint":313},"Universitair Ziekenhuis Antwerpen","Edegem","Antwerp","2650","Belgium",{"lat":314,"lon":315},51.15662,4.44504,{"facility":317,"status":8,"city":318,"state":319,"zip":320,"country":312,"geoPoint":321},"Grand Hopital de Charleroi","Charleroi","Hainaut","6000",{"lat":322,"lon":323},50.41136,4.44448,{"facility":325,"status":8,"city":326,"state":327,"zip":303,"country":312,"geoPoint":328},"UZLeuven","Leuven","Vlaams-Brabant",{"lat":329,"lon":330},50.87959,4.70093,{"facility":332,"status":8,"city":333,"state":334,"zip":335,"country":336,"geoPoint":337},"Hopital Lyon Sud","Pierre-Bénite","Auvergne-Rhône","69310","France",{"lat":338,"lon":339},45.70359,4.82424,{"facility":341,"status":8,"city":342,"state":343,"zip":344,"country":336,"geoPoint":345},"Centre Georges Francois Leclerc","Dijon","Bourgogne-Franche-Comté","21000",{"lat":346,"lon":347},47.31344,5.01391,{"facility":349,"status":8,"city":350,"state":351,"zip":352,"country":336,"geoPoint":353},"Institut Bergonie","Bordeaux","New Aquitaine","33076",{"lat":354,"lon":355},44.84124,-0.58046,{"facility":357,"status":8,"city":358,"state":359,"zip":360,"country":336,"geoPoint":361},"Centre Francois Baclesse (CFB)","Caen","Normandy","14076",{"lat":362,"lon":363},49.18585,-0.35912,{"facility":365,"status":8,"city":366,"state":367,"zip":368,"country":336,"geoPoint":369},"Centre Antoine Lacassagne","Nice","Provence Alpes Cote dAzur","06189",{"lat":370,"lon":371},43.70313,7.26608,{"facility":373,"status":8,"city":374,"state":375,"zip":376,"country":336,"geoPoint":377},"Institut Gustave Roussy","Villejuif","Île-de-France Region","94800",{"lat":378,"lon":379},48.7939,2.35992,{"facility":381,"status":8,"city":382,"zip":383,"country":384,"geoPoint":385},"Rambam Health Care Campus","Haifa","3109601","Israel",{"lat":386,"lon":387},32.81303,34.99928,{"facility":389,"status":8,"city":390,"zip":391,"country":384,"geoPoint":392},"Sharet Institute of Oncology","Jerusalem","9112001",{"lat":393,"lon":394},31.76904,35.21633,{"facility":396,"status":8,"city":397,"zip":398,"country":384,"geoPoint":399},"Sheba Medical Center","Tel Litwinsky","5265601",{"lat":400,"lon":401},32.05096,34.84588,{"facility":403,"status":8,"city":404,"state":405,"zip":406,"country":407,"geoPoint":408},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Rome","Lazio","00168","Italy",{"lat":409,"lon":410},41.89193,12.51133,{"facility":412,"status":8,"city":413,"zip":414,"country":407,"geoPoint":415},"Humanitas S. Pio X","Milan","20159",{"lat":416,"lon":417},45.46427,9.18951,{"facility":419,"status":8,"city":413,"zip":420,"country":407,"geoPoint":421},"Istituto Europeo di Oncologia","20141",{"lat":422,"lon":423},42.78235,12.59836,{"facility":425,"status":8,"city":426,"zip":427,"country":407,"geoPoint":428},"Instituto Nazionale Tumori- Fondazione Pascale","Naples","80131",{"lat":429,"lon":430},40.85216,14.26811,{"facility":432,"status":8,"city":433,"state":434,"zip":435,"country":436,"geoPoint":437},"Radboudumc","Nijmegen","Gelderland","6500HB","Netherlands",{"lat":438,"lon":439},51.8425,5.85278,{"facility":441,"status":8,"city":442,"state":443,"zip":444,"country":436,"geoPoint":445},"Erasmus MC","Rotterdam","South Holland","3000 DR",{"lat":446,"lon":447},51.9225,4.47917,{"facility":449,"status":8,"city":450,"zip":451,"country":436,"geoPoint":452},"University Medical Center Groningen","Groningen","9713 GZ",{"lat":453,"lon":454},53.21917,6.56667,{"facility":456,"status":8,"city":457,"zip":458,"country":459,"geoPoint":460},"Yonsei University Health System","Seoul","03722","South Korea",{"lat":461,"lon":462},37.566,126.9784,{"facility":464,"status":8,"city":457,"zip":465,"country":459,"geoPoint":466},"Asan Medical Center, Univ. of Ulsan","05505",{"lat":461,"lon":462},{"facility":468,"status":8,"city":457,"zip":469,"country":459,"geoPoint":470},"Samsung Medical Center","06351",{"lat":461,"lon":462},{"facility":472,"status":8,"city":457,"zip":473,"country":459,"geoPoint":474},"Korea University Guro Hospital","08307",{"lat":461,"lon":462},{"facility":476,"status":8,"city":457,"zip":477,"country":459,"geoPoint":478},"Seoul National University Hospital","3080",{"lat":461,"lon":462},{"facility":480,"status":8,"city":481,"state":482,"zip":483,"country":484,"geoPoint":485},"Clinica Universidad de Navarra","Pamplona","Navarre","31008","Spain",{"lat":486,"lon":487},42.81687,-1.64323,{"facility":489,"status":8,"city":490,"zip":491,"country":484,"geoPoint":492},"Institut Catala dOncologia Badalona","Badalona","08916",{"lat":493,"lon":494},41.45004,2.24741,{"facility":496,"status":8,"city":497,"zip":498,"country":484,"geoPoint":499},"Hospital Universitari Vall d'Hebron","Barcelona","08035",{"lat":500,"lon":501},41.38879,2.15899,{"facility":503,"status":8,"city":497,"zip":504,"country":484,"geoPoint":505},"Institut Catala d'Oncologia","8908",{"lat":500,"lon":501},{"facility":507,"status":8,"city":508,"zip":509,"country":484,"geoPoint":510},"Clinica Universidad Navarra (CUN) Madrid","Madrid","28027",{"lat":511,"lon":512},40.4165,-3.70256,{"facility":514,"status":8,"city":508,"zip":515,"country":484,"geoPoint":516},"Fundacion Jimenez Diaz","28040",{"lat":511,"lon":512},{"facility":518,"status":8,"city":508,"zip":515,"country":484,"geoPoint":519},"Hospital Universitario San Carlos",{"lat":511,"lon":512},{"facility":521,"status":8,"city":522,"zip":523,"country":484,"geoPoint":524},"Hospital Clinico Universitatio Santiago de Compostela","Santiago de Compostela","15706",{"lat":525,"lon":526},42.88052,-8.54569,{"facility":528,"status":8,"city":529,"state":530,"zip":531,"country":532,"geoPoint":533},"University of Oxford","Oxford","Oxfordshire","OX1 2JD","United Kingdom",{"lat":534,"lon":535},51.75222,-1.25596,{"facility":537,"status":241,"city":538,"state":539,"zip":540,"country":532,"geoPoint":541},"Royal Marsden Hospital - Sutton","Sutton","Surrey","SM2 5PT",{"lat":542,"lon":543},51.35,-0.2,{"facility":545,"status":8,"city":538,"state":539,"zip":540,"country":532,"geoPoint":546},"The Royal Marsden NHS Foundation Trust",{"lat":542,"lon":543},{"facility":548,"status":8,"city":549,"zip":550,"country":532,"geoPoint":551},"University College London Hospitals","London","NW1 2PG",{"lat":552,"lon":553},51.50853,-0.12574,{"facility":555,"status":8,"city":549,"zip":556,"country":532,"geoPoint":557},"Guys Hospital","SE1 9RT",{"lat":552,"lon":553},{"facility":559,"status":8,"city":549,"zip":560,"country":532,"geoPoint":561},"Imperial College Healthcare NHS Trust","W12 0HS",{"lat":552,"lon":553},{"facility":563,"status":8,"city":564,"zip":565,"country":532,"geoPoint":566},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"lat":567,"lon":568},53.48095,-2.23743,[570],{"name":571,"role":572,"phone":573,"email":574},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[576],{"name":577,"affiliation":13,"role":578},"Clinical Trial Management","STUDY_DIRECTOR",[580],{"pmid":581,"type":582,"citation":583},"39652449","DERIVED","Zhu M, Madia P, Crawford A, Brouwer-Visser J, Krueger P, Haber L, Peterman M, Uldrick TS, Miller E, Davis JD, Retter MW. Translational findings support regimen selection for first-in-human study of ubamatamab (MUC16 x CD3 bispecific antibody) in patients with recurrent ovarian cancer. Clin Transl Sci. 2024 Dec;17(12):e70082. doi: 10.1111\u002Fcts.70082.",[],{"nct_id":4,"conditions":586,"biomarkers":591},[587,588,24,589,590],"Endometrial Carcinoma","Fallopian Tube Carcinoma","Malignant Ovarian Neoplasm","Primary Peritoneal Cancer",[],{"nct_id":4,"found":593,"summary":594,"prompt_version":17},true,{"design":595,"status":596,"heading":597,"summary":598,"follow_up":599,"word_count":600,"commitments":601,"compensation":602,"drugs_mentioned":603},"This interventional study plans to enroll up to 890 participants. It is looking at the safety and effectiveness of ubamatamab alone or in combination with cemiplimab, sarilumab, or tocilizumab.","completed","Study of Ubamatamab Alone or With Cemiplimab for Recurrent Ovarian or MUC16+ Cancers","This study is looking at ubamatamab, alone or with cemiplimab, for adults with recurrent ovarian, fallopian tube, primary peritoneal, or endometrial cancer. Researchers want to learn about the safety of these drugs and find the right dose. They will also see how the drugs move through your body (pharmacokinetics) and if they can treat these cancers. The study will also explore if sarilumab or tocilizumab can help prevent or reduce a side effect called Cytokine Release Syndrome (CRS). To join, you must be a woman aged 18 or older with one of these cancers, and for ovarian cancer cohorts, have a specific CA-125 level. The study aims to enroll up to 890 participants.","Safety and side effects will be monitored for ubamatamab monotherapy for up to 2 years. Other specific follow-up durations are not detailed.",113,"Not specified in the trial record.","Not stated in the trial record.",[37,45,51,58]]