RecruitingPhase 1Phase 2NCT07293351

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)

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)

Sponsor

Bristol-Myers Squibb

Enrollment

234 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced Renal Cell Carcinoma (RCC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests the safety and effectiveness of a drug called pumitamig — alone or in combination with other treatments — in people with advanced kidney cancer (renal cell carcinoma, or RCC) that cannot be surgically removed or has spread to other organs. **You may be eligible if...** - You have been diagnosed with locally advanced, unresectable, or metastatic renal cell carcinoma (RCC) - You have clear cell RCC (the most common type) — Part 2 of the study is limited to this type - You have not received prior systemic (drug) therapy for metastatic RCC (with limited exceptions for adjuvant therapy) - You are in good general health **You may NOT be eligible if...** - You have previously received a VEGF-targeting drug for metastatic RCC - Your cancer has recurred too soon after prior adjuvant therapy - You have conditions that make the study drugs unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPumitamig

Specified dose on specified days

DRUGIpilimumab

Specified dose on specified days

DRUGCabozantinib

Specified dose on specified days

DRUGNivolumab

Specified dose on specified days

Locations(72)

Local Institution - 0117

New Haven, Connecticut, United States

Local Institution - 0134

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

Local Institution - 0126

Orlando, Florida, United States

Local Institution - 0124

Iowa City, Iowa, United States

Local Institution - 0123

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Local Institution - 0096

Hauppauge, New York, United States

Local Institution - 0135

Cincinnati, Ohio, United States

Local Institution - 0127

Cleveland, Ohio, United States

Local Institution - 0165

Charleston, South Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Local Institution - 0158

Salt Lake City, Utah, United States

Local Institution - 0095

Seattle, Washington, United States

Local Institution - 0154

Buenos Aires, Argentina

Local Institution - 0156

Buenos Aires, Argentina

Local Institution - 0076

North Ryde, New South Wales, Australia

Local Institution - 0111

St Leonards, New South Wales, Australia

Local Institution - 0074

South Brisbane, Queensland, Australia

Local Institution - 0003

Malvern, Australia

Local Institution - 0093

Brasília, Federal District, Brazil

Local Institution - 0007

Calgary, Alberta, Canada

Local Institution - 0109

Montreal, Quebec, Canada

Local Institution - 0009

Montreal, Quebec, Canada

Local Institution - 0105

Santiago, Santiago Metropolitan, Chile

Local Institution - 0005

Santiago, Santiago Metropolitan, Chile

Local Institution - 0163

Santiago, Chile

Local Institution - 0052

Cali, Colombia

Local Institution - 0147

Prague, Praha 5, Czechia

Local Institution - 0149

Brno, Czechia

Local Institution - 0150

Hradec Králové, Czechia

Local Institution - 0044

Helsinki, Etelä-Suomen Lääni, Finland

Local Institution - 0029

Turku, Finland

Local Institution - 0060

Vantaa, Finland

Local Institution - 0083

Lille, Nord, France

Local Institution - 0080

Boredeaux, France

Local Institution - 0028

Villejuif, France

Local Institution - 0025

Jena, Thuringia, Germany

Local Institution - 0026

Hamburg, Germany

Local Institution - 0014

Herne, Germany

Local Institution - 0027

München, Germany

Local Institution - 0059

Dublin, Ireland

Local Institution - 0062

Dublin, Ireland

Local Institution - 0139

Verona, Veneto, Italy

Local Institution - 0073

Milan, Italy

Local Institution - 0087

Napoli Campania, Italy

Local Institution - 0097

Koto-ku, Tokyo, Japan

Local Institution - 0078

Toyoma, Toyama, Japan

Local Institution - 0172

Fukuoka, Japan

Local Institution - 0046

Monterrey, Nuevo León, Mexico

Local Institution - 0048

Oaxaca City, Mexico

Local Institution - 0122

Puebla City, Mexico

Local Institution - 0049

Tlalpan, Mexico

Local Institution - 0108

Tlalpan, Mexico

Local Institution - 0118

Tlalpan, Mexico

Local Institution - 0103

Cluj-Napoca, Romania

Local Institution - 0161

Craiova, Romania

Local Institution - 0100

Iași, Romania

Local Institution - 0101

Sibiu, Romania

Local Institution - 0112

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0017

Seoul, Seoul-teukbyeolsi, South Korea

Local Institution - 0167

Seoul, South Korea

Local Institution - 0013

Madrid, Spain

Local Institution - 0091

Madrid, Spain

Local Institution - 0043

Seville, Spain

Local Institution - 0054

Chur, Switzerland

HOCH Health Ostschweiz

Sankt Gallen, Switzerland

Local Institution - 0056

Zurich, Switzerland

Royal Marsden Hospital (Chelsea)

London, Kensington and Chelsea, United Kingdom

Local Institution - 0057

Cardiff, United Kingdom

Local Institution - 0019

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Royal Marsden Hospital Sutton

Sulton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07293351