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)
NCT ID: NCT07293351
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
264 participants
INTERVENTIONAL
2026-03-26
2031-11-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 2B: Arm J
Pumitamig
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Part 2B: Arm K
Nivolumab
Specified dose on specified days
Part 2B: Arm L
Pumitamig
Specified dose on specified days
Part 1A: Arm A
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 1A: Arm B
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 1B: Arm G
Pumitamig
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Part 1B: Arm H
Pumitamig
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Part 2A: Arm C
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2A: Arm D
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2A: Arm E
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Part 2A: Arm F
Pumitamig
Specified dose on specified days
Part 2B: Arm I
Pumitamig
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Interventions
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Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0094
St Louis, Missouri, United States
Local Institution - 0096
Hauppauge, New York, United States
Local Institution - 0127
Cleveland, Ohio, United States
Local Institution - 0165
Charleston, South Carolina, United States
Local Institution - 0114
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 - 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
Local Institution - 0055
Sankt Gallen, , Switzerland
Local Institution - 0056
Zurich, , Switzerland
Local Institution - 0057
Cardiff, , United Kingdom
Local Institution - 0019
London, , United Kingdom
Local Institution - 0063
London, , United Kingdom
Local Institution - 0020
Manchester, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0117
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Site 0134
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Site 0126
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Site 0124
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Site 0123
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Site 0094
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Site 0096
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Site 0127
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Site 0165
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Site 0114
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Site 0095
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Site 0154
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Site 0156
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Site 0076
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Site 0111
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Site 0074
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Site 0003
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Site 0093
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Site 0007
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Site 0109
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Site 0009
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Site 0105
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Site 0005
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Site 0163
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Site 0052
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Site 0147
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Site 0149
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Site 0150
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Site 0044
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Site 0029
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Site 0060
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Site 0083
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Site 0080
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Site 0028
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Site 0025
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Site 0026
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Site 0014
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Site 0027
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Site 0059
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Site 0062
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Site 0139
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Site 0073
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Site 0087
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Site 0097
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Site 0078
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Site 0046
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Site 0048
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Site 0122
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Site 0049
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Site 0108
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Site 0118
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Site 0103
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Site 0161
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Site 0100
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Site 0101
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Site 0112
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Site 0017
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Site 0167
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Site 0013
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Site 0091
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Site 0043
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Site 0054
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Site 0055
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Site 0056
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Site 0057
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Site 0019
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Site 0063
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Site 0020
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA266-0008
Identifier Type: -
Identifier Source: org_study_id
2025-523637-26
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1327-6332
Identifier Type: OTHER
Identifier Source: secondary_id