Study of Pumitamig for Advanced Renal Cell Carcinoma (RCC)
This study is testing Pumitamig, by itself or with Ipilimumab or Cabozantinib, for people with advanced renal cell carcinoma (kidney cancer). Researchers want to see how safe these treatments are and how well they work. You may be able to join if you are 18 or older and have kidney cancer that has spread or cannot be removed by surgery. The study will look at side effects and serious side effects for up to two years after treatment ends. This study is currently unclear on its recruitment status and plans to enroll 254 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 254 participants, but the phase is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events and serious adverse events for up to approximately two years from the end of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
Recruiting
PHASE1Ages 18+InterventionalTreatmentBristol-Myers Squibb
~474 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PumitamigIpilimumabCabozantinibCasdatifan
At a glance
Recruiting sites
24 of 92 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to approximately 2 years from end of treatment
+5 more outcomes measured
Conditions
Where it's being run
92 sites across 60 statesMexico5
United Kingdom5
Romania4
Germany3
Spain3
Switzerland3
Florida2
Ohio2
Study leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Exclusion
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.
What this trial measures
- Number of participants with adverse events (AEs)Up to approximately 2 years from end of treatment
Phase 1
- Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))Up to approximately 2 years from end of treatment
Phase 1
- Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteriaUp to day 21 from first dose
Phase 1
- Number of participants with AEs leading to discontinuationUp to approximately 2 years from end of treatment
Phase 1
- Number of participants with AEs leading to deathUp to approximately 2 years from end of treatment
Phase 1
- Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessmentUp to approximately 2 years from end of treatment
Phase 2