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RecruitingInterventionalPhase 1/Phase 2

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC)

NCT ID: NCT07293351Sponsor: Bristol-Myers SquibbLast updated: 2026-05-26

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)

Arms & interventions

  • DrugPumitamig

    Specified dose on specified days

  • DrugIpilimumab

    Specified dose on specified days

  • DrugCabozantinib

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with adverse events (AEs)

    Phase 1

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))

    Phase 1

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Phase 1

    Time frame: Up to day 21 from first dose

  • Number of participants with AEs leading to discontinuation

    Phase 1

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with AEs leading to death

    Phase 1

    Time frame: Up to approximately 2 years from end of treatment

  • 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

    Phase 2

    Time frame: Up to approximately 2 years from end of treatment

Secondary

  • Number of participants with AEs

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with SAEs (as per CTCAE v5)

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with treatment-related adverse events (TRAEs)

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2 years from end of treatment

  • Number of participants with AEs leading to death

    Time frame: Up to approximately 2 years from end of treatment

  • Progression-free survival (PFS) by RECIST v1.1 per investigator assessment

    Time frame: Up to 4 years from randomization

  • Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 2 years from end of treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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. \- 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, or congenital long QT syndrome. * Participants must not have a urine protein ≥ 2+ and 24 hour urine protein ≥ 1 g at baseline. * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations (13)

Local Institution - 0117

New Haven, Connecticut, 06510

Not Yet Recruiting
Site 0117 · Contact

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016

Recruiting
Yasser Ged, Site 0134 · Contact

Local Institution - 0126

Orlando, Florida, 32803

Not Yet Recruiting
Site 0126 · Contact

Local Institution - 0124

Iowa City, Iowa, 52242

Not Yet Recruiting
Site 0124 · Contact

Johns Hopkins Hospital

Baltimore, Maryland, 21287

Recruiting
Yasser Ged, Site 0123 · Contact

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Melissa Reimers, Site 0094 · Contact

Local Institution - 0096

Hauppauge, New York, 11788

Not Yet Recruiting
Site 0096 · Contact

Local Institution - 0135

Cincinnati, Ohio, 45219

Not Yet Recruiting
Site 0135 · Contact

Local Institution - 0127

Cleveland, Ohio, 44195

Not Yet Recruiting
Site 0127 · Contact

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425

Recruiting
Thai Ho, Site 0165 · Contact

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572

Recruiting
Neal Shore, Site 0114 · Contact

Local Institution - 0158

Salt Lake City, Utah, 84112

Withdrawn

Local Institution - 0095

Seattle, Washington, 98109-1023

Not Yet Recruiting
Site 0095 · Contact
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) | Cancerify