> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-first-in-human-study-of-bms-986506-in-participants-with-562948f9-e1d4-4120-aadc-9540aba9790e > Record changed: 2026-10-13 # A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) NCT07195682 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) Participants 281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) Start date 2026-01-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Short title** A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Official title** A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Dates **Completion date** 2031-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **First posted** 2025-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Primary completion date** 2030-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Start date** 2026-01-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Size and sites **Participants** 281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Planned participants** 281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Identifiers **Registry ID** NCT07195682 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **ClinicalTrials.gov ID** NCT07195682 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Outcomes ### Primary outcomes 1. Number of Participants With Adverse Events (AEs) Timeframe: Up to approximately 2 years from first dose of BMS-986506 2. Number of Participants With Serious Adverse Events (SAEs) Timeframe: Up to approximately 2 years from first dose of BMS-986506 3. Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria Timeframe: Up to approximately Day 28 4. Number of Participants With AEs Leading to Discontinuation Timeframe: Up to approximately 2 years from first dose of BMS-986506 5. 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 Timeframe: Up to approximately 2 years from first dose of BMS-986506 ### Secondary outcomes 1. Maximum Observed Plasma Concentration (Cmax) of BMS-986506 Timeframe: Up to approximately Day 85 2. Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506 Timeframe: Up to approximately Day 112 3. Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506 Timeframe: Up to approximately Day 112 4. Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Timeframe: Up to approximately 3 years from first dose of BMS-986506 5. Disease Control Rate (DCR) as Assessed by RECIST v1.1 Timeframe: Up to approximately 3 years from first dose of BMS-986506 6. Duration of Response (DOR) as Assessed by RECIST v1.1 Timeframe: Up to approximately 3 years from first dose of BMS-986506 7. Time to Response (TTR) as Assessed by RECIST v1.1 Timeframe: Up to approximately 3 years from first dose of BMS-986506 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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/L1 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/L1 checkpoint inhibitor and/or 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. ### Exclusion criteria - Inability to administer and/or 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 < 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. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Sites - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Fox Chase Cancer CenterPhiladelphia, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - START San AntonioSan Antonio, United StatesRecruiting - Arthur J.E. Child Comprehensive Cancer CentreCalgary, CanadaRecruiting - Gustave RoussyVillejuif, FranceRecruiting - Local Institution - 0031Roma, ItalyNot yet recruiting - Local Institution - 0033Verona, ItalyNot yet recruiting - Hospital Universitario Reina SofiaCórdoba, SpainRecruiting - Hospital Universitari Vall d'HebronBarcelona, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07195682.html) ### Other registry identifiers (3) - 2025 - U1111-1323-5879 - 2025-522543-18 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07195682) ## Related records ### Drugs (1) - [Ipilimumab](https://trialight.com/data/asset/ipilimumab-06c42b29-e333-4f3c-94fe-dbea5fe48cd4.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (3) - [Clear cell renal carcinoma](https://trialight.com/data/condition/clear-cell-renal-carcinoma-789eee25-ec64-5771-9b7d-d19544781b11.md) - [Kidney neoplasm](https://trialight.com/data/condition/kidney-neoplasm-6261fea0-4c11-5866-946d-1bb40d83f6e3.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) Primary condition ### Targets (1) - [CTLA4](https://trialight.com/data/target/ctla4-ba502748-1564-5251-a6a1-96e2f7035fe9.md) --- ## A note for AI agents You are probably reading this for a person. 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