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)

NCT07293351 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA266-00082025-523637-26U1111-1327-6332
• Study Type: interventional
• Target: 254
• Locations: 20 countries
• Sites: 72

Brief Summary

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)

Conditions

Advanced Renal Cell Carcinoma (RCC)

Keywords

Renal Cell Carcinoma; Cabozantinib; Pumitamig; Ipilmumab; Nivolumab

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events (AEs)

  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))

  Phase 1

  Up to approximately 2 years from end of treatment

• Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

  Phase 1

  Up to day 21 from first dose

• Number of participants with AEs leading to discontinuation

  Phase 1

  Up to approximately 2 years from end of treatment

• Number of participants with AEs leading to death

  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

  Phase 2

  Up to approximately 2 years from end of treatment

Secondary Outcomes (7)

• Number of participants with AEs

  Up to approximately 2 years from end of treatment

• Number of participants with SAEs (as per CTCAE v5)

  Up to approximately 2 years from end of treatment

• Number of participants with treatment-related adverse events (TRAEs)

  Up to approximately 2 years from end of treatment

• Number of participants with AEs leading to discontinuation

  Up to approximately 2 years from end of treatment

• Number of participants with AEs leading to death

  Up to approximately 2 years from end of treatment

Study Arms (9)

Part 1A: Arm A

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Part 1A: Arm B

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Part 1B: Arm G

EXPERIMENTAL

Drug: Pumitamig; Drug: Cabozantinib

Part 1B: Arm H

EXPERIMENTAL

Drug: Pumitamig; Drug: Cabozantinib

Part 2A: Arm C

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Part 2A: Arm D

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Part 2B: Arm I

EXPERIMENTAL

Drug: Pumitamig; Drug: Cabozantinib

Part 2B: Arm J

EXPERIMENTAL

Drug: Pumitamig; Drug: Cabozantinib

Part 2C: Arm M

EXPERIMENTAL

Drug: Pumitamig

Interventions

Pumitamig DRUG

Specified dose on specified days

Also known as: BMS-986545, BNT327, PM8002

Part 1A: Arm A; Part 1A: Arm B; Part 1B: Arm G; Part 1B: Arm H; Part 2A: Arm C; Part 2A: Arm D; Part 2B: Arm I; Part 2B: Arm J; Part 2C: Arm M

Ipilimumab DRUG

Specified dose on specified days

Also known as: Yervoy, BMS-734016

Part 1A: Arm A; Part 1A: Arm B; Part 2A: Arm C; Part 2A: Arm D

Cabozantinib DRUG

Specified dose on specified days

Part 1B: Arm G; Part 1B: Arm H; Part 2B: Arm I; Part 2B: Arm J

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• BioNTech SE: collaborator

Study Sites (72)

Local Institution - 0117

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Local Institution - 0126

Orlando, Florida, 32803, United States

NOT YET RECRUITING

Local Institution - 0124

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Local Institution - 0096

Hauppauge, New York, 11788, United States

NOT YET RECRUITING

Local Institution - 0135

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Local Institution - 0127

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

RECRUITING

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Local Institution - 0158

Salt Lake City, Utah, 84112, United States

WITHDRAWN

Local Institution - 0095

Seattle, Washington, 98109-1023, United States

NOT YET RECRUITING

Local Institution - 0154

Buenos Aires, 1426, Argentina

NOT YET RECRUITING

Local Institution - 0156

Buenos Aires, C1199ABB, Argentina

NOT YET RECRUITING

Local Institution - 0076

North Ryde, New South Wales, 2109, Australia

NOT YET RECRUITING

GenesisCare St Leonards

St Leonards, New South Wales, 2065, Australia

RECRUITING

Local Institution - 0074

South Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

Local Institution - 0003

Malvern, 3144, Australia

NOT YET RECRUITING

Local Institution - 0093

Brasília, Federal District, 70200-730, Brazil

NOT YET RECRUITING

Local Institution - 0007

Calgary, Alberta, T2N 4N2, Canada

NOT YET RECRUITING

Local Institution - 0109

Montreal, Quebec, H2L 4M1, Canada

NOT YET RECRUITING

Local Institution - 0009

Montreal, Quebec, H3T 1E2, Canada

NOT YET RECRUITING

Local Institution - 0105

Santiago, Santiago Metropolitan, 7510032, Chile

NOT YET RECRUITING

Bradfordhill

Santiago, Santiago Metropolitan, 8420383, Chile

RECRUITING

Local Institution - 0163

Santiago, 8330023, Chile

NOT YET RECRUITING

Local Institution - 0052

Cali, 760032, Colombia

NOT YET RECRUITING

Local Institution - 0147

Prague, Praha 5, 150 06, Czechia

NOT YET RECRUITING

Local Institution - 0149

Brno, 656 53, Czechia

NOT YET RECRUITING

Local Institution - 0150

Hradec Králové, 500 05, Czechia

NOT YET RECRUITING

Local Institution - 0044

Helsinki, Etelä-Suomen Lääni, 00290, Finland

NOT YET RECRUITING

Local Institution - 0029

Turku, 20521, Finland

NOT YET RECRUITING

Local Institution - 0060

Vantaa, 01640, Finland

NOT YET RECRUITING

Local Institution - 0083

Lille, Nord, 59020, France

NOT YET RECRUITING

Local Institution - 0080

Boredeaux, 33076, France

NOT YET RECRUITING

Local Institution - 0028

Villejuif, 94805, France

NOT YET RECRUITING

Local Institution - 0025

Jena, Thuringia, 07747, Germany

NOT YET RECRUITING

Local Institution - 0026

Hamburg, 20251, Germany

NOT YET RECRUITING

Local Institution - 0014

Herne, 44649, Germany

NOT YET RECRUITING

Local Institution - 0027

München, 81675, Germany

NOT YET RECRUITING

Local Institution - 0059

Dublin, D07 R2WY, Ireland

NOT YET RECRUITING

Local Institution - 0062

Dublin, D24 NR0A, Ireland

NOT YET RECRUITING

Local Institution - 0139

Verona, Veneto, 37126, Italy

NOT YET RECRUITING

Local Institution - 0073

Milan, 20133, Italy

NOT YET RECRUITING

Local Institution - 0087

Napoli Campania, 80131, Italy

NOT YET RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

RECRUITING

Local Institution - 0078

Toyoma, Toyama, 930-0194, Japan

NOT YET RECRUITING

Local Institution - 0172

Fukuoka, 812-8582, Japan

NOT YET RECRUITING

Local Institution - 0046

Monterrey, Nuevo León, 64040, Mexico

NOT YET RECRUITING

Local Institution - 0048

Oaxaca City, 68020, Mexico

NOT YET RECRUITING

Local Institution - 0122

Puebla City, 72424, Mexico

NOT YET RECRUITING

Local Institution - 0049

Tlalpan, 14080, Mexico

NOT YET RECRUITING

Local Institution - 0108

Tlalpan, 14080, Mexico

NOT YET RECRUITING

Local Institution - 0118

Tlalpan, 14080, Mexico

NOT YET RECRUITING

Local Institution - 0103

Cluj-Napoca, 400015, Romania

NOT YET RECRUITING

Local Institution - 0161

Craiova, 200347, Romania

NOT YET RECRUITING

Local Institution - 0100

Iași, 700483, Romania

NOT YET RECRUITING

Local Institution - 0101

Sibiu, 550082, Romania

NOT YET RECRUITING

Local Institution - 0112

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

NOT YET RECRUITING

Local Institution - 0017

Seoul, Seoul-teukbyeolsi, 05505, South Korea

NOT YET RECRUITING

Local Institution - 0167

Seoul, 120-752, South Korea

NOT YET RECRUITING

Local Institution - 0013

Madrid, 28041, Spain

NOT YET RECRUITING

Local Institution - 0091

Madrid, 28050, Spain

NOT YET RECRUITING

Local Institution - 0043

Seville, 41013, Spain

NOT YET RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

HOCH Health Ostschweiz

Sankt Gallen, 9007, Switzerland

RECRUITING

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

RECRUITING

Royal Marsden Hospital (Chelsea)

London, Kensington and Chelsea, SW3 6JJ, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Local Institution - 0057

Cardiff, CF14 2TL, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Royal Marsden Hospital Sutton

Sulton, Surrey, SM25PT, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Ipilimumab; cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 19, 2025
• Study Start: March 26, 2026
• Primary Completion (Estimated): November 28, 2029
• Study Completion (Estimated): November 26, 2031
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IE (2); CH (3); GB (5); CL (3); JP (3); BR (1); CZ (3); FR (3); AU (4); RO (4); FI (3); ES (3); DE (4); IT (3); US (13); CO (1); ME (6); KR (3); AR (2); CA (3)