Clinical trial Recruiting at 34 sites Phase1; Phase2 Interventional Ages 18 and up

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.

More Renal Cell Carcinoma (RCC) trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment474 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsipilimumab, cabozantinib, radiation, prednisone
Locations95 sites (Palo Alto, California and 94 other locations)
StatusRecruiting
StartedMarch 26, 2026
Main results expectedNovember 28, 2029
Study endsNovember 26, 2031
Registry record updatedOctober 23, 2026
Trial IDNCT07293351 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.