> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-f09db6b0-53bf-442e-9885-43e7225ef84f > Record changed: 2026-10-13 # A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) NCT07293351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) Participants 474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) Start date 2026-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) Number of sites 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Title and summary **Summary** The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with other agents in participants with advanced Renal Cell Carcinoma (RCC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Short title** A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Official title** ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Dates **Completion date** 2031-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **First posted** 2025-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Primary completion date** 2029-11-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Start date** 2026-03-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Size and sites **Participants** 474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Planned participants** 474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Number of sites** 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Identifiers **Registry ID** NCT07293351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **ClinicalTrials.gov ID** NCT07293351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Outcomes ### Primary outcomes 1. Number of participants with adverse events (AEs) Timeframe: Up to approximately 2 years from end of treatment Phase 1 2. Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) Timeframe: Up to approximately 2 years from end of treatment Phase 1 3. Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria Timeframe: Up to day 21 from first dose Phase 1 4. Number of participants with AEs leading to discontinuation Timeframe: Up to approximately 2 years from end of treatment Phase 1 5. Number of participants with AEs leading to death Timeframe: Up to approximately 2 years from end of treatment Phase 1 6. Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment Timeframe: Up to approximately 2 years from end of treatment Phase 2 ### Secondary outcomes 1. Number of participants with AEs Timeframe: Up to approximately 2 years from end of treatment Phase 2 2. Number of participants with SAEs (as per CTCAE v5) Timeframe: Up to approximately 2 years from end of treatment Phase 2 3. Number of participants with treatment-related adverse events (TRAEs) Timeframe: Up to approximately 2 years from end of treatment Phase 2 4. Number of participants with AEs leading to discontinuation Timeframe: Up to approximately 2 years from end of treatment Phase 2 5. Number of participants with AEs leading to death Timeframe: Up to approximately 2 years from end of treatment Phase 2 6. Progression-free survival (PFS) by RECIST v1.1 per investigator assessment Timeframe: Up to 4 years from randomization Phase 2 7. Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment Timeframe: Up to approximately 2 years from end of treatment Phase 2 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC). - Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1\. Note: Part 2 may only enroll participants with ccRCC. - Participants may have favorable, intermediate or poor risk disease categories. - Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy. ii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab). iii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib. iv) For Parts 2D and 2E: Prior treatment with a HIF-2α inhibitor or other agent that targets the HIF-2α pathway is not allowed. \- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. ### Exclusion criteria - Participants must not have any untreated known CNS metastases. - Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1). - Participants must not have a history of interstitial lung disease or pneumonitis. - Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures. - Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, left ventricular ejection fraction (LVEF) <50% (for Part 2D and 2E) or congenital long QT syndrome. - Participants must not have a urine protein ≥ 2+ on dipstick or urinalysis at baseline and confirmed proteinuria ≥ 1 g/24 hours or urine protein-creatinine ratio (UPCR) > 1000 mg/g. - Participants must not have evidence of major coagulation disorders. - Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1. - Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months. - Participants must not have had a major surgery or trauma within 28 days prior to C1D1. - For Part 2D and 2E: Receiving ongoing concomitant treatment with sensitive substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 with narrow therapeutic indices within 5 half-lives of the concomitant treatment or up to 28 days, whichever is shorter, prior to randomization. - For Part 2D and 2E: Receiving ongoing concomitant treatment with moderate or strong CYP3A4 inducers, or moderate or strong CYP3A4 inhibitors within 5 half-lives of the concomitant treatment, or up to 28 days, whichever is shorter, prior to randomization. - For Part 2D and 2E: Has hypoxia defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen. - For Part 2D and 2E: Exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%. - For Part 2D and 2E: Presence of significant pulmonary disease/condition (eg, chronic obstructive pulmonary disease, pleural effusion, etc) that, in the opinion of the Investigator, could put participant at increased risk from study intervention or impact interpretation of safety data. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Sites - Local Institution - 0178Palo Alto, United StatesNot yet recruiting - Local Institution - 0117New Haven, United StatesNot yet recruiting - Sibley Memorial HospitalWashington D.C., United StatesRecruiting - Local Institution - 0177Miami, United StatesNot yet recruiting - Local Institution - 0126Orlando, United StatesNot yet recruiting - Local Institution - 0175Atlanta, United StatesNot yet recruiting - Local Institution - 0170Fort Wayne, United StatesNot yet recruiting - University Of Iowa Hospitals And ClinicsIowa City, United StatesRecruiting - Johns Hopkins HospitalBaltimore, United StatesRecruiting - Local Institution - 0176Big Rapids, United StatesNot yet recruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterHauppauge, United StatesRecruiting - Local Institution - 0135Cincinnati, United StatesNot yet recruiting - Cleveland ClinicCleveland, United StatesRecruiting - MUSC Hollings Cancer CenterCharleston, United StatesRecruiting - Carolina Urologic Research Center, LLCMyrtle Beach, United StatesRecruiting - Local Institution - 0158Salt Lake City, United StatesWithdrawn - Local Institution - 0095Seattle, United StatesNot yet recruiting - Instituto Medico Especializado Alexander FlemingBuenos Aires, ArgentinaRecruiting - Local Institution - 0156Buenos Aires, ArgentinaNot yet recruiting - Macquarie UniversityNorth Ryde, AustraliaRecruiting - GenesisCare St LeonardsSt Leonards, AustraliaRecruiting - Mater Misericordiae LimitedBrisbane, AustraliaRecruiting - Local Institution - 0011Herston, AustraliaNot yet recruiting - Local Institution - 0004Heidelberg, AustraliaNot yet recruiting And 67 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## 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/NCT07293351.html) ### Other registry identifiers (2) - U1111-1327-6332 - 2026-527163-15-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07293351) ## Related records ### Drugs (3) - [Cabozantinib](https://trialight.com/data/asset/cabozantinib-e69f9fa7-bbbc-4e52-b0df-6073598de2a7.md) - [Casdatifan](https://trialight.com/data/asset/casdatifan-bbad1c6e-e20a-41c3-a739-d7f295439886.md) - [Ipilimumab](https://trialight.com/data/asset/ipilimumab-06c42b29-e333-4f3c-94fe-dbea5fe48cd4.md) ### Collaborators (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (1) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) Primary condition ### Targets (3) - [CTLA4](https://trialight.com/data/target/ctla4-ba502748-1564-5251-a6a1-96e2f7035fe9.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [MET](https://trialight.com/data/target/met-f2eb67de-39d3-5026-b4c1-2c5017d5c5b2.md) --- ## A note for AI agents You are probably reading this for a person. 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