OncoMatch/Clinical Trials/NCT07293351
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)
Is NCT07293351 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Pumitamig and Ipilimumab for advanced renal cell carcinoma (rcc).
Treatment: Pumitamig · Ipilimumab · Cabozantinib · Nivolumab — 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)
Check if I qualifyExtracted eligibility criteria
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 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. For Part 1A: 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). 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.
Lab requirements
Cardiac function
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 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Local Institution - 0117 · New Haven, Connecticut
- Local Institution - 0134 · Washington D.C., District of Columbia
- Local Institution - 0126 · Orlando, Florida
- Local Institution - 0124 · Iowa City, Iowa
- Local Institution - 0123 · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify