Recruiting
Phase 1
Phase 2

Pumitamig, Ipilimumab, Cabozantinib

Sponsor:

Bristol-Myers Squibb

Code:

NCT07293351

Conditions

Advanced Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Ipilimumab

Cabozantinib

Casdatifan

Study Details

Brief 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)

Conditions

Advanced Renal Cell Carcinoma (RCC)

Study ID

NCT07293351

Start date

Mar 26, 2026

Status verified date

Aug, 2026

Completion date

Nov 26, 2031

Anticipated

Primary completion date

Nov 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

474 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A: 1A-1 Pumitamig + Ipilimumab

experimental: Part 1A: 1A-2 Pumitamig + Ipilimumab

experimental: Part 1B: 1B-1 Pumitamig + Cabozantinib

experimental: Part 1B: 1B-2 Pumitamig + Cabozantinib

experimental: Part 2A: 2A-1 Pumitamig + Ipilimumab

experimental: Part 2A: 2A-2 Pumitamig + Ipilimumab

experimental: Part 2B: 2B-1 Pumitamig + Cabozantinib

experimental: Part 2B: 2B-2 Pumitamig + Cabozantinib

experimental: Part 2C: 2C-1 Pumitamig

experimental: Part 2D: 2D-1 Pumitamig + Casdatifan

experimental: Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan

Interventions

Pumitamig

Specified dose on specified days

Ipilimumab

Specified dose on specified days

Cabozantinib

Specified dose on specified days

Casdatifan

Specified dose on specified days

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: 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 ]
  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: 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 ]
  • Number of participants with AEs leading to death [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Sibley Memorial Hospital

Recruiting

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

Contacts

Yasser Ged, Site 0134

410-570-9410

University Of Iowa Hospitals And Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Yasser Ged, Site 0123

410-570-9410

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Melissa Reimers, Site 0094

314-362-5740

Memorial Sloan Kettering Cancer Center

Recruiting

Hauppauge, New York, United States, 11788

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Moshe Ornstein, Site 0127

216-445-6592

MUSC Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Thai Ho, Site 0165

843-792-9300

Carolina Urologic Research Center, LLC

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Neal Shore, Site 0114

843-449-1010

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Renal Cell Carcinoma
  • Cabozantinib
  • Pumitamig
  • Ipilmumab
  • Casdatifan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-28.