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Pumitamig alone or with ipilimumab or cabozantinib for advanced kidney cancer

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)

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT07293351

This trial will test whether pumitamig by itself or combined with ipilimumab or cabozantinib helps people with advanced renal cell carcinoma.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment234 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsipilimumab, cabozantinib, radiation, prednisone
Locations72 sites (New Haven, Connecticut and 71 other locations)
Trial IDNCT07293351 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional trial examines pumitamig given alone or together with ipilimumab or cabozantinib in adults with locally advanced, unresectable, or metastatic renal cell carcinoma. Part 1 includes dose-escalation and combination cohorts that may enroll clear cell and select non-clear cell histologies, while Part 2 focuses on clear cell RCC. The main outcomes are safety, tolerability, and anti-tumor activity measured by response rates and progression-free survival. Eligible participants undergo regular clinic visits for infusions, monitoring, laboratory tests, and imaging.

Who should consider this trial

Good fit: Adults with histologically confirmed locally advanced, unresectable, or metastatic RCC who meet the protocol criteria and have not had prior systemic therapy for metastatic disease (with limited exceptions) are the intended candidates.

Not a fit: Patients with disallowed prior therapies, incompatible tumor histologies, or who cannot attend visits at the participating U.S. sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that shrinks tumors or delays progression in advanced RCC.

How similar studies have performed: Combinations of immune checkpoint inhibitors and targeted kinase inhibitors have shown benefit in RCC, but pumitamig is a novel agent and its specific combinations remain under clinical testing.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

New Haven, Connecticut and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Renal Cell CarcinomaRenal Cell CarcinomaCabozantinibPumitamigIpilmumabNivolumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.