Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07293351

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)

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)

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto Medico Especializado Alexander Fleming, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327, PM8002

Ipilimumab

Drug

Specified dose on specified days

Other names: Yervoy, BMS-734016

Cabozantinib

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 2 years from end of treatment

    Phase 1

  2. 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

    Phase 1

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

    Time frame: Up to day 21 from first dose

    Phase 1

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2 years from end of treatment

    Phase 1

  5. Number of participants with AEs leading to death

    Time frame: Up to approximately 2 years from end of treatment

    Phase 1

  6. 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

    Phase 2

Secondary outcomes

  1. Number of participants with AEs

    Time frame: Up to approximately 2 years from end of treatment

    Phase 2

  2. Number of participants with SAEs (as per CTCAE v5)

    Time frame: Up to approximately 2 years from end of treatment

    Phase 2

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

    Time frame: Up to approximately 2 years from end of treatment

    Phase 2

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2 years from end of treatment

    Phase 2

  5. Number of participants with AEs leading to death

    Time frame: Up to approximately 2 years from end of treatment

    Phase 2

  6. Progression-free survival (PFS) by RECIST v1.1 per investigator assessment

    Time frame: Up to 4 years from randomization

    Phase 2

  7. Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 2 years from end of treatment

    Phase 2

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • BioNTech SE

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Dec 19, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.