A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

May 21, 2026 updated by: Bristol-Myers Squibb

ROSETTA RCC-208: 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)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Not yet recruiting
        • Local Institution - 0154
        • Contact:
          • Site 0154
      • Buenos Aires, Argentina, C1199ABB
        • Not yet recruiting
        • Local Institution - 0156
        • Contact:
          • Site 0156
  • Australia
      • Malvern, Australia, 3144
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • New South Wales
      • North Ryde, New South Wales, Australia, 2109
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • GenesisCare St Leonards
        • Contact:
          • Laurence Krieger, Site 0111
          • Phone Number: 61294631172
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
      • Montreal, Quebec, Canada, H3T 1E2
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
  • Chile
      • Santiago, Chile, 8330023
        • Not yet recruiting
        • Local Institution - 0163
        • Contact:
          • Site 0163
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Recruiting
        • Bradfordhill
        • Contact:
          • Carlos Rojas, Site 0005
          • Phone Number: +56998744662
      • Santiago, Santiago Metropolitan, Chile, 7510032
        • Not yet recruiting
        • Local Institution - 0105
        • Contact:
          • Site 0105
  • Colombia
      • Cali, Colombia, 760032
        • Not yet recruiting
        • Local Institution - 0052
        • Contact:
          • Site 0052
  • Czechia
      • Brno, Czechia, 656 53
        • Not yet recruiting
        • Local Institution - 0149
        • Contact:
          • Site 0149
      • Hradec Králové, Czechia, 500 05
        • Not yet recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Not yet recruiting
        • Local Institution - 0147
        • Contact:
          • Site 0147
  • Finland
      • Turku, Finland, 20521
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
      • Vantaa, Finland, 01640
        • Not yet recruiting
        • Local Institution - 0060
        • Contact:
          • Site 0060
    • Etelä-Suomen Lääni
      • Helsinki, Etelä-Suomen Lääni, Finland, 00290
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
  • France
      • Boredeaux, France, 33076
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
      • Villejuif, France, 94805
        • Not yet recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • Nord
      • Lille, Nord, France, 59020
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
  • Germany
      • Hamburg, Germany, 20251
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Herne, Germany, 44649
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • München, Germany, 81675
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
      • Dublin, Ireland, D24 NR0A
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
  • Italy
      • Milan, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
      • Napoli Campania, Italy, 80131
        • Not yet recruiting
        • Local Institution - 0087
        • Contact:
          • Site 0087
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Not yet recruiting
        • Local Institution - 0139
        • Contact:
          • Site 0139
  • Japan
      • Fukuoka, Japan, 812-8582
        • Not yet recruiting
        • Local Institution - 0172
        • Contact:
          • Site 0172
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of JFCR
        • Contact:
          • Yuji Miura, Site 0097
          • Phone Number: 81335200111
    • Toyama
      • Toyoma, Toyama, Japan, 930-0194
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
  • Mexico
      • Oaxaca City, Mexico, 68020
        • Not yet recruiting
        • Local Institution - 0048
        • Contact:
          • Site 0048
      • Puebla City, Mexico, 72424
        • Not yet recruiting
        • Local Institution - 0122
        • Contact:
          • Site 0122
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0108
        • Contact:
          • Site 0108
      • Tlalpan, Mexico, 14080
        • Not yet recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64040
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Not yet recruiting
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Craiova, Romania, 200347
        • Not yet recruiting
        • Local Institution - 0161
        • Contact:
          • Site 0161
      • Iași, Romania, 700483
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
      • Sibiu, Romania, 550082
        • Not yet recruiting
        • Local Institution - 0101
        • Contact:
          • Site 0101
  • South Korea
      • Seoul, South Korea, 120-752
        • Not yet recruiting
        • Local Institution - 0167
        • Contact:
          • Site 0167
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05505
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
  • Spain
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Local Institution - 0091
        • Contact:
          • Site 0091
      • Seville, Spain, 41013
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
  • Switzerland
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubunden
        • Contact:
          • Richard Cathomas, Site 0054
          • Phone Number: 41812566646
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Hoch Health Ostschweiz
        • Contact:
          • Tobias Peres, Site 0055
          • Phone Number: 0767931903
      • Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich
        • Contact:
          • Anja Lorch, Site 0056
          • Phone Number: 492118108776
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Not yet recruiting
        • Local Institution - 0057
        • Contact:
          • Site 0057
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Tom Waddell, Site 0020
          • Phone Number: +441619187217
      • Sulton, Surrey, United Kingdom, SM25PT
        • Recruiting
        • Royal Marsden Hospital Sutton
        • Contact:
          • James Larkin, Site 0171
          • Phone Number: 442078082132
    • Kensington and Chelsea
      • London, Kensington and Chelsea, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital (Chelsea)
        • Contact:
          • James Larkin, Site 0063
          • Phone Number: 442078082132
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew'S Hospital
        • Contact:
          • Thomas Powles, Site 0019
          • Phone Number: 02078228498
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Local Institution - 0117
        • Contact:
          • Site 0117
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Contact:
          • Yasser Ged, Site 0134
          • Phone Number: 410-570-9410
    • Florida
      • Orlando, Florida, United States, 32803
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Yasser Ged, Site 0123
          • Phone Number: 410-570-9410
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Melissa Reimers, Site 0094
          • Phone Number: 314-362-5740
    • New York
      • Hauppauge, New York, United States, 11788
        • Not yet recruiting
        • Local Institution - 0096
        • Contact:
          • Site 0096
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Not yet recruiting
        • Local Institution - 0135
        • Contact:
          • Site 0135
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Local Institution - 0127
        • Contact:
          • Site 0127
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • MUSC Hollings Cancer Center
        • Contact:
          • Thai Ho, Site 0165
          • Phone Number: 843-792-9300
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center, LLC
        • Contact:
          • Neal Shore, Site 0114
          • Phone Number: 843-449-1010
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Withdrawn
        • Local Institution - 0158
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Not yet recruiting
        • Local Institution - 0095
        • Contact:
          • Site 0095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

- 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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: Arm A
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 1A: Arm B
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 1B: Arm G
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 1B: Arm H
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2A: Arm C
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2A: Arm D
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2B: Arm I
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2B: Arm J
Drug: Cabozantinib
Specified dose on specified days
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545
Experimental: Part 2C: Arm M
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
  • PM8002
  • BMS-986545

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to day 21 from first dose
Phase 1
Up to day 21 from first dose
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years from end of treatment
Phase 1
Up to approximately 2 years from end of treatment
Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with AEs
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with SAEs (as per CTCAE v5)
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with treatment-related adverse events (TRAEs)
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Time Frame: Up to 4 years from randomization
Phase 2
Up to 4 years from randomization
Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment
Time Frame: Up to approximately 2 years from end of treatment
Phase 2
Up to approximately 2 years from end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

BioNTech SE

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2026

Primary Completion (Estimated)

November 28, 2029

Study Completion (Estimated)

November 26, 2031

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA266-0008
  • 2025-523637-26 (Other Identifier: EU CT Number)
  • U1111-1327-6332 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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