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RECRUITING

NCT07293351

PHASE1/PHASE2

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2026-03-26

Completion Date

2031-11-26

Last Updated

2026-08-28

Healthy Volunteers

Conditions

Advanced Renal Cell Carcinoma (RCC)

Interventions

DRUG

Pumitamig

Specified dose on specified days

DRUG

Ipilimumab

Specified dose on specified days

DRUG

Cabozantinib

Specified dose on specified days

DRUG

Casdatifan

Specified dose on specified days

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.

Locations (92)

Local Institution - 0178

Palo Alto, California, United States

Local Institution - 0117

New Haven, Connecticut, United States

Sibley Memorial Hospital

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

Local Institution - 0177

Miami, Florida, United States

Local Institution - 0126

Orlando, Florida, United States

Local Institution - 0175

Atlanta, Georgia, United States

Local Institution - 0170

Fort Wayne, Indiana, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Local Institution - 0176

Big Rapids, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

Hauppauge, New York, United States

Local Institution - 0135

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

MUSC Hollings Cancer Center

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

Instituto Medico Especializado Alexander Fleming

Buenos Aires, Argentina

Local Institution - 0156

Buenos Aires, Argentina

Macquarie University

North Ryde, New South Wales, Australia

GenesisCare St Leonards

St Leonards, New South Wales, Australia

Mater Misericordiae Limited

Brisbane, Queensland, Australia

Local Institution - 0011

Herston, Queensland, Australia

Local Institution - 0004

Heidelberg, Victoria, Australia

Local Institution - 0003

Malvern, Australia

Hospital Sirio Libanes

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

Bradfordhill

Santiago, Santiago Metropolitan, Chile

Local Institution - 0163

Santiago, Chile

Local Institution - 0143

Beijing, Beijing Municipality, China

Local Institution - 0157

Beijing, Beijing Municipality, China

Local Institution - 0182

Guangzhou, Guangdong, China

Local Institution - 0183

Changsha Shi, Hunan, China

Local Institution - 0184

Nanjing, Jiangsu, China

Local Institution - 0188

Shanghai Shi, Shanghai Municipality, China

Local Institution - 0144

Beijing, China

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 - 0180

Kobe, Hyōgo, Japan

Local Institution - 0179

Shiwa-gun Yahaba-cho, Iwate, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Local Institution - 0078

Toyoma, Toyama, Japan

Kyushu University Hospital

Fukuoka, Japan

Local Institution - 0181

Niigata, 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

Kantonsspital Graubünden

Chur, Switzerland

HOCH Health Ostschweiz

Sankt Gallen, Switzerland

UniversitätsSpital Zürich

Zurich, Switzerland

Royal Marsden Hospital (Chelsea)

London, Kensington and Chelsea, United Kingdom

St Bartholomew's Hospital

London, London, City of, United Kingdom

Local Institution - 0186

Preston, North West, United Kingdom

Local Institution - 0022

Cambridge, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Local Institution - 0061

Edinburgh, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Royal Marsden Hospital Sutton

Sulton, Surrey, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (92)