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NCT07293351PHASE1, PHASE2Recruiting

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)

Bristol-Myers Squibb

Start Date

3/26/2026

Completion Date

11/26/2031

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)

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Pumitamig

DRUG

Ipilimumab

DRUG

Cabozantinib

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Conditions

Advanced Renal Cell Carcinoma (RCC)

Locations

Local Institution - 0178

Palo Alto, California 94305

United States

Local Institution - 0117

New Haven, Connecticut 06510

United States

Sibley Memorial Hospital

Washington D.C., District of Columbia 20016

United States

Local Institution - 0177

Miami, Florida 33136

United States

Local Institution - 0126

Orlando, Florida 32803

United States

Local Institution - 0175

Atlanta, Georgia 30322

United States

Local Institution - 0170

Fort Wayne, Indiana 46825

United States

Local Institution - 0124

Iowa City, Iowa 52242

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Local Institution - 0176

Big Rapids, Michigan 49307

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center

Hauppauge, New York 11788

United States

Local Institution - 0135

Cincinnati, Ohio 45219

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

MUSC Hollings Cancer Center

Charleston, South Carolina 29425

United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina 29572

United States

Local Institution - 0158

Salt Lake City, Utah 84112

United States

Local Institution - 0095

Seattle, Washington 98109-1023

United States

Instituto Medico Especializado Alexander Fleming

Buenos Aires, 1426

Argentina

Local Institution - 0156

Buenos Aires, C1199ABB

Argentina

Macquarie University

North Ryde, New South Wales 2109

Australia

GenesisCare St Leonards

St Leonards, New South Wales 2065

Australia

Local Institution - 0011

Herston, Queensland 4029

Australia

Local Institution - 0074

South Brisbane, Queensland 4101

Australia

Local Institution - 0003

Malvern, 3144

Australia

Hospital Sirio Libanes

Brasília, Federal District 70200-730

Brazil

Local Institution - 0007

Calgary, Alberta T2N 4N2

Canada

Local Institution - 0109

Montreal, Quebec H2L 4M1

Canada

Local Institution - 0009

Montreal, Quebec H3T 1E2

Canada

Local Institution - 0105

Santiago, Santiago Metropolitan 7510032

Chile

Bradfordhill

Santiago, Santiago Metropolitan 8420383

Chile

Local Institution - 0163

Santiago, 8330023

Chile

Local Institution - 0143

Beijing, Beijing Municipality 100142

China

Local Institution - 0157

Beijing, Beijing Municipality 102200

China

Local Institution - 0182

Guangzhou, Guangdong 510555

China

Local Institution - 0183

Changsha Shi, Hunan 410013

China

Local Institution - 0184

Nanjing, Jiangsu 210008

China

Local Institution - 0188

Shanghai Shi, Shanghai Municipality 200032

China

Local Institution - 0144

Beijing, 100034

China

Local Institution - 0052

Cali, 760032

Colombia

Local Institution - 0147

Prague, Praha 5 150 06

Czechia

Local Institution - 0149

Brno, 656 53

Czechia

Local Institution - 0150

Hradec Králové, 500 05

Czechia

Local Institution - 0044

Helsinki, Etelä-Suomen Lääni 00290

Finland

Local Institution - 0029

Turku, 20521

Finland

Local Institution - 0060

Vantaa, 01640

Finland

Local Institution - 0083

Lille, Nord 59020

France

Local Institution - 0080

Boredeaux, 33076

France

Local Institution - 0028

Villejuif, 94805

France

Local Institution - 0025

Jena, Thuringia 07747

Germany

Local Institution - 0026

Hamburg, 20251

Germany

Local Institution - 0014

Herne, 44649

Germany

Local Institution - 0027

München, 81675

Germany

Local Institution - 0059

Dublin, D07 R2WY

Ireland

Local Institution - 0062

Dublin, D24 NR0A

Ireland

Local Institution - 0139

Verona, Veneto 37126

Italy

Local Institution - 0073

Milan, 20133

Italy

Local Institution - 0087

Napoli Campania, 80131

Italy

Local Institution - 0180

Kobe, Hyōgo 650-0017

Japan

Local Institution - 0179

Shiwa-gun Yahaba-cho, Iwate 028-3695

Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo 135-8550

Japan

Local Institution - 0078

Toyoma, Toyama 930-0194

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

Local Institution - 0181

Niigata, 951-8520

Japan

Local Institution - 0046

Monterrey, Nuevo León 64040

Mexico

Local Institution - 0048

Oaxaca City, 68020

Mexico

Local Institution - 0122

Puebla City, 72424

Mexico

Local Institution - 0049

Tlalpan, 14080

Mexico

Local Institution - 0108

Tlalpan, 14080

Mexico

Local Institution - 0118

Tlalpan, 14080

Mexico

Local Institution - 0103

Cluj-Napoca, 400015

Romania

Local Institution - 0161

Craiova, 200347

Romania

Local Institution - 0100

Iași, 700483

Romania

Local Institution - 0101

Sibiu, 550082

Romania

Local Institution - 0112

Seoul, Seoul-teukbyeolsi [Seoul] 06351

South Korea

Local Institution - 0017

Seoul, Seoul-teukbyeolsi 05505

South Korea

Local Institution - 0167

Seoul, 120-752

South Korea

Local Institution - 0013

Madrid, 28041

Spain

Local Institution - 0091

Madrid, 28050

Spain

Local Institution - 0043

Seville, 41013

Spain

Kantonsspital Graubünden

Chur, 7000

Switzerland

HOCH Health Ostschweiz

Sankt Gallen, 9007

Switzerland

UniversitätsSpital Zürich

Zurich, 8091

Switzerland

Royal Marsden Hospital (Chelsea)

London, Kensington and Chelsea SW3 6JJ

United Kingdom

St Bartholomew's Hospital

London, London, City of EC1A 7BE

United Kingdom

Local Institution - 0186

Preston, North West PR29HT

United Kingdom

Local Institution - 0022

Cambridge, CB2 2QQ

United Kingdom

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

Local Institution - 0061

Edinburgh, EH4 2XU

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom

Royal Marsden Hospital Sutton

Sulton, Surrey, SM25PT

United Kingdom