Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
ROSETTA RCC-208
Clinical summary
Summary
This clinical trial is testing a treatment called pumitamig for people with advanced kidney cancer, also known as renal cell carcinoma (RCC). Researchers want to find out how safe the treatment is, how well it works, and whether it may help control cancer growth.
Who can take part?
You may be eligible if:
- you have advanced kidney cancer (renal cell carcinoma or RCC).
- your cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery or treated with curative radiation.
- you have received little or no previous drug treatment for metastatic kidney cancer, although some previous treatments may be allowed depending on the study group.
What does participation involve?
Depending on the study group, participants may receive:
- Pumitamig on its own, or
- Pumitamig together with ipilimumab, an immunotherapy, or
- Pumitamig together with cabozantinib, a targeted therapy.
Participants will also attend regular study visits, which may include health checks, blood tests, scans and monitoring for side effects.
Conditions
This trial is treating people with locally advanced, unresectable or metastatic renal cell carcinoma
Eligibility
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.
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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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT07293351 *
- 2025-523637-26 *
- CA266-0008; U1111-1327-6332
Trial sponsor
Bristol-Myers Squibb
Scientific Title
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)
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