[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07195682":3,"trial-entities:NCT07195682":264,"trial-summary:NCT07195682":268},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":58,"secondary_outcomes":71,"sex":89,"minimum_age":90,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":108,"locations":111,"central_contacts":246,"overall_officials":253,"references":256,"see_also_links":257},"NCT07195682","CA242-0001","A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","A Phase 1\u002F1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","RECRUITING","2031-04-03","2026-08","2026-08-11","2026-01-15","Bristol-Myers Squibb","INDUSTRY",false,"This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.",null,[19],"Renal Cell Carcinoma",[21,22,23,24],"Metastatic clear cell renal cell carcinoma","Advanced clear cell renal cell carcinoma","ccRCC","Kidney cancer","INTERVENTIONAL","TREATMENT",[28],"PHASE1",{"count":30,"type":31},281,"ESTIMATED",[33,45,52],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","BMS-986506","Specified dose on specified days",[38,39,40,41,42,43,44],"Part 1A BMS-986506 Monotherapy Escalation","Part 2A BMS-986506 Monotherapy Expansion","Part 2B BMS-986506 Monotherapy Expansion","Part 3A BMS-986506 + Pumitamig Combination Dose Escalation","Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation","Part 4A BMS-986506 + Pumitamig Combination Dose Expansion","Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion",{"type":34,"name":46,"description":36,"armGroupLabels":47,"otherNames":48},"Pumitamig",[41,42,43,44],[49,50,51],"BMS-986545","BNT327","PM8002",{"type":34,"name":53,"description":36,"armGroupLabels":54,"otherNames":55},"Ipilimumab",[42,44],[56,57],"Yervoy","BMS-734016",[59,62,64,67,69],{"measure":60,"timeFrame":61},"Number of Participants With Adverse Events (AEs)","Up to approximately 2 years from first dose of BMS-986506",{"measure":63,"timeFrame":61},"Number of Participants With Serious Adverse Events (SAEs)",{"measure":65,"timeFrame":66},"Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria","Up to approximately Day 28",{"measure":68,"timeFrame":61},"Number of Participants With AEs Leading to Discontinuation",{"measure":70,"timeFrame":61},"Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0",[72,75,78,80,83,85,87],{"measure":73,"timeFrame":74},"Maximum Observed Plasma Concentration (Cmax) of BMS-986506","Up to approximately Day 85",{"measure":76,"timeFrame":77},"Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506","Up to approximately Day 112",{"measure":79,"timeFrame":77},"Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506",{"measure":81,"timeFrame":82},"Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)","Up to approximately 3 years from first dose of BMS-986506",{"measure":84,"timeFrame":82},"Disease Control Rate (DCR) as Assessed by RECIST v1.1",{"measure":86,"timeFrame":82},"Duration of Response (DOR) as Assessed by RECIST v1.1",{"measure":88,"timeFrame":82},"Time to Response (TTR) as Assessed by RECIST v1.1","ALL","18 Years",{"inclusion":92,"exclusion":99,"raw_text":107},[93,94,95,96,97,98],"Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.","For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.","For part 2: Participants must have had at least one standard treatment plan that included both a PD-1\u002FL1 inhibitor and a VEGF-TKI (either together or one after the other).","Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1\u002FL1 checkpoint inhibitor and\u002For a VEGF-TKI).","Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.","Eastern Cooperative Oncology Group performance status of 0 to 1.",[100,101,102,103,104,105,106],"Inability to administer and\u002For tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.","Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.","Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).","Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).","Participants who have hypoxia as defined by a pulse oximeter reading \\\u003C 92% at rest or requires intermittent or chronic supplemental oxygen.","Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.","Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.","Inclusion Criteria\n\n* Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.\n* For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.\n* For part 2: Participants must have had at least one standard treatment plan that included both a PD-1\u002FL1 inhibitor and a VEGF-TKI (either together or one after the other).\n* Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1\u002FL1 checkpoint inhibitor and\u002For a VEGF-TKI).\n* Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.\n* Eastern Cooperative Oncology Group performance status of 0 to 1.\n\nExclusion Criteria\n\n* Inability to administer and\u002For tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.\n* Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.\n* Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).\n* Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).\n* Participants who have hypoxia as defined by a pulse oximeter reading \\\u003C 92% at rest or requires intermittent or chronic supplemental oxygen.\n* Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.\n* Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",[109,110],"ADULT","OLDER_ADULT",[112,126,137,149,161,173,186,199,211,221,234],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":123},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215","United States",[119],{"name":120,"role":121,"phone":122},"Stephanie Berg, Site 0006","CONTACT","617-632-4932",{"lat":124,"lon":125},42.35843,-71.05977,{"facility":127,"status":8,"city":128,"state":128,"zip":129,"country":117,"contacts":130,"geoPoint":134},"Memorial Sloan Kettering Cancer Center","New York","10065",[131],{"name":132,"role":121,"phone":133},"Martin Voss, Site 0029","646-888-4721",{"lat":135,"lon":136},40.71427,-74.00597,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":117,"contacts":142,"geoPoint":146},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",[143],{"name":144,"role":121,"phone":145},"Elizabeth Plimack, Site 0002","215-728-3889",{"lat":147,"lon":148},39.95238,-75.16362,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":117,"contacts":154,"geoPoint":158},"SCRI Oncology Partners","Nashville","Tennessee","37203",[155],{"name":156,"role":121,"phone":157},"Benjamin Garmezy, Site 0026","713-444-7804",{"lat":159,"lon":160},36.16589,-86.78444,{"facility":162,"status":8,"city":163,"state":164,"zip":165,"country":117,"contacts":166,"geoPoint":170},"START San Antonio","San Antonio","Texas","78229",[167],{"name":168,"role":121,"phone":169},"Amita Patnaik, Site 0001","210-593-5250",{"lat":171,"lon":172},29.42412,-98.49363,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":178,"contacts":179,"geoPoint":183},"Arthur J.E. Child Comprehensive Cancer Centre","Calgary","Alberta","T2N 5G2","Canada",[180],{"name":181,"role":121,"phone":182},"Daniel Heng, Site 0021","4035213166",{"lat":184,"lon":185},51.05011,-114.08529,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":191,"contacts":192,"geoPoint":196},"Gustave Roussy","Villejuif","Val-de-Marne","94800","France",[193],{"name":194,"role":121,"phone":195},"Christophe Massard, Site 0008","+33142114211",{"lat":197,"lon":198},48.7939,2.35992,{"facility":200,"status":201,"city":202,"zip":203,"country":204,"contacts":205,"geoPoint":208},"Local Institution - 0031","NOT_YET_RECRUITING","Roma","00168","Italy",[206],{"name":207,"role":121},"Site 0031",{"lat":209,"lon":210},44.99364,11.10642,{"facility":212,"status":201,"city":213,"zip":214,"country":204,"contacts":215,"geoPoint":218},"Local Institution - 0033","Verona","37134",[216],{"name":217,"role":121},"Site 0033",{"lat":219,"lon":220},45.43854,10.9938,{"facility":222,"status":8,"city":223,"state":224,"zip":225,"country":226,"contacts":227,"geoPoint":231},"Hospital Universitario Reina Sofia","Córdoba","Andalusia","14004","Spain",[228],{"name":229,"role":121,"phone":230},"MARIA JOSE MENDEZ VIDAL, Site 0015","+34957011448",{"lat":232,"lon":233},37.89155,-4.77275,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":226,"contacts":239,"geoPoint":243},"Hospital Universitari Vall d'Hebron","Barcelona","Barcelona [Barcelona]","08035",[240],{"name":241,"role":121,"phone":242},"Cristina Suarez Rodriguez, Site 0018","349327460004350",{"lat":244,"lon":245},41.38879,2.15899,[247,251],{"name":248,"role":121,"phone":249,"email":250},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":252,"role":121},"First line of the email MUST contain NCT # and Site #.",[254],{"name":13,"affiliation":13,"role":255},"STUDY_DIRECTOR",[],[258,261],{"label":259,"url":260},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":262,"url":263},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT07195682.html",{"nct_id":4,"conditions":265,"biomarkers":267},[266],"Clear Cell Renal Cell Carcinoma",[],{"nct_id":4,"found":269,"summary":270,"prompt_version":280},true,{"design":271,"status":272,"heading":273,"summary":274,"follow_up":275,"word_count":276,"commitments":277,"compensation":278,"drugs_mentioned":279},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 125 participants.","completed","Study of BMS-986506 for Advanced Clear Cell Kidney Cancer","This study is testing a new drug called BMS-986506 for people with advanced clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. It's the first time this drug is being given to humans. The main goal is to see if BMS-986506 is safe and how well people can tolerate it when taken alone. You might be able to join if you have advanced ccRCC and have already received certain treatments, including immunotherapy and targeted therapy. The study will look at side effects and serious side effects for up to two years to understand the drug's safety. The study is currently recruiting about 125 participants.","Participants will be followed for adverse events and serious adverse events for up to approximately 2 years from the first dose of BMS-986506.",106,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]