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OncoMatch/Clinical Trials/NCT07293351

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)

Is NCT07293351 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including Pumitamig and Ipilimumab for advanced renal cell carcinoma (rcc).

Phase 1/2RecruitingBristol-Myers SquibbNCT07293351Data as of Sep 2026Location: International · 21 countries

Treatment: Pumitamig · Ipilimumab · Cabozantinib · CasdatifanThe 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)

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Ipilimumab

Targeted therapy

Cabozantinib

Other

PumitamigCasdatifan

Cancer type

Renal Cell Carcinoma

Prior therapy

Cannot have received: systemic therapy for metastatic RCC

Exception: One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy. For Part 1A: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting CTLA-4 (e.g., ipilimumab). For Part 1B: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.

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.

Cannot have received: HIF-2A inhibitor or other agent that targets the HIF-2A pathway

For Parts 2D and 2E: Prior treatment with a HIF-2α inhibitor or other agent that targets the HIF-2α pathway is not allowed.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Local Institution - 0178 · Palo Alto, California
  • Local Institution - 0117 · New Haven, Connecticut
  • Sibley Memorial Hospital · Washington D.C., District of Columbia
  • Local Institution - 0177 · Miami, Florida
  • Local Institution - 0126 · Orlando, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07293351 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic therapy for metastatic RCC, HIF-2A inhibitor or other agent that targets the HIF-2A pathway disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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