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)
ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC)
- Advanced Renal Cell Carcinoma (RCC)
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Bristol-Myers Squibb
- Enrolment target
- 474
- Started
- 26 March 2026
- Main results due
- 28 November 2029
- Study sites
- 95
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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. iv) For Parts 2D and 2E: Prior treatment with a HIF-2α inhibitor or other agent that targets the HIF-2α pathway is not allowed. \- 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, 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. * Other protocol-defined Inclusion/Exclusion criteria apply.
What this study is about
In the sponsor’s own words, from the registry.
The 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)
Study sites(95)
Local Institution - 0178
Palo Alto, California, United States
Not yet recruiting
Local Institution - 0117
New Haven, Connecticut, United States
Not yet recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Recruiting
Local Institution - 0177
Miami, Florida, United States
Not yet recruiting
Local Institution - 0126
Orlando, Florida, United States
Not yet recruiting
Local Institution - 0170
Fort Wayne, Indiana, United States
Not yet recruiting
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States
Recruiting
Local Institution - 0176
Big Rapids, Michigan, United States
Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Local Institution - 0135
Cincinnati, Ohio, United States
Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Recruiting
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Recruiting
Local Institution - 0158
Salt Lake City, Utah, United States
Withdrawn
Local Institution - 0095
Seattle, Washington, United States
Not yet recruiting
Asociación de Beneficencia Hospital Sirio Libanés
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Argentina
Recruiting
Local Institution - 0156
Buenos Aires, Argentina
Not yet recruiting
Macquarie University
North Ryde, New South Wales, Australia
Recruiting
GenesisCare St Leonards
St Leonards, New South Wales, Australia
Recruiting
Mater Misericordiae Limited
Brisbane, Queensland, Australia
Recruiting
Local Institution - 0011
Herston, Queensland, Australia
Not yet recruiting
Local Institution - 0004
Heidelberg, Victoria, Australia
Not yet recruiting
Cabrini Hospital - Malvern
Malvern, Victoria, Australia
Recruiting
Local Institution - 0007
Calgary, Alberta, Canada
Not yet recruiting
Local Institution - 0189
Edmonton, Alberta, Canada
Not yet recruiting
Local Institution - 0109
Montreal, Quebec, Canada
Withdrawn
Local Institution - 0009
Montreal, Quebec, Canada
Not yet recruiting
Local Institution - 0006
Québec, Quebec, Canada
Not yet recruiting
Local Institution - 0105
Santiago, Santiago Metropolitan, Chile
Not yet recruiting
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Recruiting
Local Institution - 0163
Santiago, Chile
Not yet recruiting
Local Institution - 0143
Beijing, Beijing Municipality, China
Not yet recruiting
Local Institution - 0157
Beijing, Beijing Municipality, China
Not yet recruiting
Local Institution - 0182
Guangzhou, Guangdong, China
Not yet recruiting
Local Institution - 0145
Tianjin, Hebei, China
Not yet recruiting
Local Institution - 0187
Harbin, Heilongjiang, China
Not yet recruiting
Local Institution - 0183
Changsha Shi, Hunan, China
Not yet recruiting
Local Institution - 0184
Nanjing, Jiangsu, China
Not yet recruiting
Local Institution - 0188
Shanghai Shi, Shanghai Municipality, China
Not yet recruiting
Local Institution - 0144
Beijing, China
Not yet recruiting
Local Institution - 0052
Cali, Colombia
Not yet recruiting
Local Institution - 0147
Prague, Praha 5, Czechia
Not yet recruiting
Local Institution - 0149
Brno, Czechia
Not yet recruiting
Local Institution - 0150
Hradec Králové, Czechia
Not yet recruiting
Local Institution - 0044
Helsinki, Etelä-Suomen Lääni, Finland
Not yet recruiting
Local Institution - 0029
Turku, Finland
Not yet recruiting
Local Institution - 0060
Vantaa, Finland
Not yet recruiting
Local Institution - 0083
Lille, Nord, France
Not yet recruiting
Local Institution - 0080
Boredeaux, France
Not yet recruiting
Local Institution - 0028
Villejuif, France
Not yet recruiting
Local Institution - 0025
Jena, Thuringia, Germany
Not yet recruiting
Local Institution - 0026
Hamburg, Germany
Not yet recruiting
Local Institution - 0014
Herne, Germany
Not yet recruiting
Local Institution - 0027
München, Germany
Not yet recruiting
Local Institution - 0059
Dublin, Ireland
Not yet recruiting
Local Institution - 0062
Dublin, Ireland
Not yet recruiting
Local Institution - 0139
Verona, Veneto, Italy
Not yet recruiting
Showing 60 of 95 sites — filter to narrow it down. 28 of the 95 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07293351. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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