A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
NCT ID: NCT07291076
Last Updated: 2025-12-22
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
129 participants
INTERVENTIONAL
2026-02-09
2031-10-14
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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Cohort 1A
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort 1B
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort 2A
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort 2B
Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort 2C
Atezolizumab
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Cohort 2D
Pumitamig
Specified dose on specified days
Interventions
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Pumitamig
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Atezolizumab
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants must have no prior systemic therapy for advanced/ unresectable HCC.
* Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
* Participants must not have an organ transplant or autoimmune disease.
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 - 0070
Los Angeles, California, United States
Local Institution - 0103
Hackensack, New Jersey, United States
Local Institution - 0100
Great Neck, New York, United States
Local Institution - 0080
Portland, Oregon, United States
Local Institution - 0022
Nashville, Tennessee, United States
Local Institution - 0102
Nashville, Tennessee, United States
Local Institution - 0083
Seattle, Washington, United States
Local Institution - 0040
Birtinya, Queensland, Australia
Local Institution - 0024
Camperdown, , Australia
Local Institution - 0096
Melbourne, , Australia
Local Institution - 0033
Wentworthville, , Australia
Local Institution - 0064
Santiago, Santiago Metropolitan, Chile
Local Institution - 0106
Santiago Region Metropolitana, Santiago Metropolitan, Chile
Local Institution - 0086
Xi'an, Shaanxi, China
Local Institution - 0059
Rennes, Ille-et-Vilaine, France
Local Institution - 0004
Grenoble, Isère, France
Local Institution - 0018
Saint Priest En Jarez, Pays de la Loire Region, France
Local Institution - 0003
Bobigny, , France
Local Institution - 0031
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0028
Kiel, Schleswig-Holstein, Germany
Local Institution - 0030
Frankfurt, , Germany
Local Institution - 0109
Pisa, Tuscany, Italy
Local Institution - 0088
Milan, , Italy
Local Institution - 0016
Pisa, , Italy
Local Institution - 0046
Rozzano (MI), , Italy
Local Institution - 0021
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0105
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0020
Gdansk, , Poland
Local Institution - 0009
Singapore, , Singapore
Local Institution - 0012
Singapore, , Singapore
Local Institution - 0027
Seongnam-si, Gyeonggi-do, South Korea
Local Institution - 0013
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0011
Seoul, Seoul-teukbyeolsi, South Korea
Local Institution - 0014
Pamplona, Navarre, Spain
Local Institution - 0060
Madrid, , Spain
Local Institution - 0032
Taichung, , Taiwan
Local Institution - 0055
Tainan, Taiana, , Taiwan
Local Institution - 0006
Taipei, , Taiwan
Local Institution - 0007
Taipei, , Taiwan
Local Institution - 0073
London, London, City of, United Kingdom
Local Institution - 0051
Glasgow, South Western Scotland, United Kingdom
Local Institution - 0053
Metropolitan Borough of Wirral, , 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 0070
Role: primary
Site 0103
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Site 0100
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Site 0080
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Site 0022
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Site 0102
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Site 0083
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Site 0040
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Site 0024
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Site 0096
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Site 0033
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Site 0064
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Site 0106
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Site 0086
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Site 0059
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Site 0004
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Site 0018
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Site 0003
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Site 0031
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Site 0028
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Site 0030
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Site 0109
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Site 0088
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Site 0016
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Site 0046
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Site 0021
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Site 0105
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Site 0020
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Site 0009
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Site 0012
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Site 0027
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Site 0013
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Site 0011
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Site 0014
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Site 0060
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Site 0032
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Site 0055
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Site 0006
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Site 0007
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Site 0073
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Site 0051
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Site 0053
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-523602-33
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1327-4912
Identifier Type: OTHER
Identifier Source: secondary_id
CA266-0006
Identifier Type: -
Identifier Source: org_study_id