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)
Summary description of the study
The aim 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).
(BASEC)
Intervention under investigation
Parallel Assignment:
Experimental: Part 1A: Arm A
Fixed dose on specified days
Other names:
• BMS-986545
Drug:
Ipilimumab
Fixed dose on
specified days
Other names:
• Yervoy
Experimental: Part 1A: Arm B
Pumitamig Drug: Fixed dose on specified days
Other names:
• BMS-986545
Drug: Ipilimumab Fixed dose on specified days
Other names:
• Yervoy
Experimental: Part 1B: Arm G
Fixed dose on specific days
Other names:
• BMS-986545
Drug: Cabozantinib
Fixed dose on specified days
Experimental: Part 1B: Arm H
Drug: Pumitamig. Fixed dose on specified days
Other names:
• BMS-986545
Drug: Cabozantinib fixed dose on
specified days
Experimental: Part 2A: Arm C
Drug: Pumitamig. Fixed dose on specified days
Other names:
• BMS-986545
Drug:
Ipilimumab Specified dose on specified days
Other names:
Yervoy
Experimental: Part 2A: Arm D
Drug: Pumitamig. Fixed dose on specified days
Other names:
• BMS-986545
Drug:
Ipilimumab Fixed dose on specified days
Other names:
Yervoy
Part 2A: Arm E
Drug: Ipilimumab. Fixed
Dose on specified days
Other names:
• Yervoy-Drug: Nivolumab
Fixed dose on specified
Days
Other names:
• Opdivo
Experimental: Part 2A: Arm F
Drug: Pumitamig. Fixed dose on specified days
Other names:
• BMS-986545
Experimental: Part 2B: Arm I
Drug: Pumitamig. Fixed dose on specified days
Other names:
• BMS-986545
Drug: Cabozantinib Fixed dose on specified days
Experimental: Part 2B: Arm J
Drug: Pumitamig. Fixed dose on specified days
Other names: • BMS-986545
Drug: Cabozantinib Fixed dose on
specified days
Part 2B: Arm K
Drug: Nivolumab Specified
Dose on specific days
Other names:
• Opdivo
Experimental: Part 2B: Arm L
Drug: Pumitamig. Fixed dose on specified days
Other names:
• BMS-986545
(BASEC)
Disease under investigation
Advanced Renal Cell Carcinoma (RCC)
(BASEC)
• Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not suitable for curative surgery or radiotherapy) or metastatic renal cell carcinoma (RCC).
• Participants must have clear RCC (ccRCC) or non-clear RCC (nccRCC) that can be included in Part 1. Note: Part 2 can only include participants with ccRCC.
• Participants can be classified into the risk categories of 'favorable', 'intermediate', or 'unfavorable'.
• Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions:
i) A prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if this therapy does not contain any agents targeting vascular endothelial growth factors (VEGF) or VEGF receptors, and if a relapse occurs at least 6 months after the last dose of the adjuvant or neoadjuvant therapy.
ii) For participants in Part 1A: A prior systemic therapy in the metastatic setting is allowed if the participant has not received therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., Ipilimumab).
iii) For participants in Part 1B: A prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with Cabozantinib.
- Participants must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. • Other protocol-defined inclusion/exclusion criteria apply.
(BASEC)
Exclusion criteria
Participants must not have untreated known CNS metastases.
Participants must not have received systemic treatment with corticosteroids (> daily 10 mg prednisone equivalent) or other immunosuppressive medications within 14 days prior to Cycle 1 Day 1 (C1D1).
• Participants must not have a history of interstitial lung disease or pneumonitis.
• Participants must not have uncontrolled pleural or pericardial effusion requiring repeated therapeutic drainage procedures.
• Participants must not have significant cardiovascular diseases such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accidents, or uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical treatment.
• Participants must not have urine protein ≥ 2+ and 24-hour urine protein ≥ 1 g at baseline.
• Participants must not have evidence of significant coagulation disorders.
• Participants must not have a history of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic events 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 undergone major surgery or experienced trauma within 28 days prior to C1D1.
• Other protocol-defined inclusion/exclusion criteria apply.
(BASEC)
Trial sites
Chur, St. Gallen, Zurich
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Plaza 254, Blanchardstown Corporate Park 2, Ballycoolin, Dublin 15, D15 T867, Ireland
(BASEC)
Contact
Contact Person Switzerland
Dr. med Tobias Peres
Tel: +41 71 494 29 22
tobias.peres@clutterh-och.chHOCH Health Ostschweiz (Kantonsspital St. Gallen) Klinik für Medizinische Onkologie und Hämatologie Rorschacher Strasse 95 9007 St. Gallen Switzerland
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
26.02.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Protocol Title: ROSETTARCC-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) (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available