Pumitamig alone or with ipilimumab or cabozantinib for advanced kidney cancer
Official title: 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)
Run by Bristol-Myers Squibb · NCT07293351 · Data updated 2026-11-12
This trial will test whether pumitamig by itself or combined with ipilimumab or cabozantinib helps people with advanced renal cell carcinoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 474 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | ipilimumab, cabozantinib, radiation, prednisone |
| Locations | 95 sites (Palo Alto, California and 94 other locations) |
| Status | Recruiting |
| Started | March 26, 2026 |
| Main results expected | November 28, 2029 |
| Study ends | November 26, 2031 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07293351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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. 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.
Where it's running
-
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States Recruiting -
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States Recruiting -
Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Show 44 more locations
-
MUSC Hollings Cancer Center
Charleston, South Carolina, United States Recruiting -
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States 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 -
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 -
Cabrini Hospital - Malvern
Malvern, Victoria, Australia Recruiting -
Bradfordhill
Santiago, Santiago Metropolitan, Chile Recruiting -
Pontificia Universidad Catolica de Chile (PUC)
Santiago, Chile Recruiting -
Gustave Roussy
Villejuif, Val-de-Marne, France Recruiting -
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
München, Germany Recruiting -
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan Recruiting -
Toyama University Hospital
Toyoma, Toyama, Japan Recruiting -
Kyushu University Hospital
Fukuoka, Japan Recruiting -
Centrul de Oncologie Sf. Nectarie SRL
Craiova, Romania Recruiting -
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea Recruiting -
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea Recruiting -
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea Recruiting -
Kantonsspital Graubünden
Chur, Switzerland Recruiting -
HOCH Health Ostschweiz
Sankt Gallen, Switzerland Recruiting -
UniversitätsSpital Zürich
Zurich, Switzerland Recruiting -
Royal Marsden Hospital (Chelsea)
London, Kensington and Chelsea, United Kingdom Recruiting -
St Bartholomew's Hospital
London, London, City of, United Kingdom Recruiting -
Addenbrooke's Hospital
Cambridge, United Kingdom Recruiting -
Velindre Cancer Centre
Cardiff, United Kingdom Recruiting -
The Christie NHS Foundation Trust
Manchester, United Kingdom Recruiting -
Royal Marsden Hospital Sutton
Sulton, Surrey, United Kingdom Recruiting -
Local Institution - 0178
Palo Alto, California, United States Not yet recruiting -
Local Institution - 0117
New Haven, Connecticut, United States Not yet 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 -
Local Institution - 0176
Big Rapids, Michigan, United States Not yet recruiting -
Local Institution - 0135
Cincinnati, Ohio, United States Not yet recruiting -
Local Institution - 0158
Salt Lake City, Utah, United States Withdrawn -
Local Institution - 0095
Seattle, Washington, United States Not yet recruiting -
Local Institution - 0156
Buenos Aires, Argentina Not yet recruiting -
Local Institution - 0011
Herston, Queensland, Australia Not yet recruiting -
Local Institution - 0004
Heidelberg, Victoria, Australia Not yet 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
+45 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Nectin-4 PET/CT imaging to differentiate renal tumors
This study tests a new PET tracer, 18F-N230A, to see if it helps distinguish renal cell carcinoma from renal pelvic urothelial carcinoma in adults.
-
Weight-loss programs to slow kidney cancer progression in small renal masses on active surveillance
This study tests two weight-loss approaches, daily calorie restriction and 5:2 intermittent fasting, to see if they help people with small kidney tumors on active surveillance lose weight and potentially slow cancer progression.
-
Predicting Toripalimab Response in High-Risk Recurrent Renal Cell Carcinoma using MRD
This study tests whether measuring minimal residual disease after surgery can predict which high-risk RCC patients will benefit from adjuvant Toripalimab.
-
Safety and tolerability test of anti-CD70 T-cell therapy in advanced RCC
This study tests a CD70-targeted CAR-T cell therapy in adults with advanced or metastatic renal cell carcinoma to see if it is safe and tolerable and to identify a usable dose for future studies.
-
VMD-102 in liver cancer and other solid tumors
This study tests VMD-102 to see if it is safe and tolerable and to find the best dose for further study in adults with advanced liver cancer and several other solid tumors.
-
Registry of Minimally Invasive Cancer Treatments Using Spectral Angio-CT Guidance
This registry collects data from adults undergoing image-guided, minimally invasive cancer treatments to see if spectral angio-CT guidance helps predict outcomes and improve planning.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.