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)

May 29, 2026 updated by: Bristol-Myers Squibb

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

The purpose of this study is 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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
          • Simone Strasser, Site 0024
          • Phone Number: 61295150056
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital
        • Contact:
          • James O'Beirne, Site 0040
          • Phone Number: +617520203155
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • The Royal Melbourne Hospital
        • Contact:
          • Ashok Raj, Site 0096
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Recruiting
        • Bradfordhill
        • Contact:
          • Carlos Rojas, Site 0064
          • Phone Number: +56998744662
      • Santiago Region Metropolitana, Santiago Metropolitan, Chile, 8330034
        • Not yet recruiting
        • Local Institution - 0106
        • Contact:
          • Site 0106
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100036
        • Not yet recruiting
        • Local Institution - 0114
        • Contact:
          • Site 0114
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Not yet recruiting
        • Local Institution - 0125
        • Contact:
          • Site 0125
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Not yet recruiting
        • Local Institution - 0130
        • Contact:
          • Site 0130
    • Henan
      • Nanyang, Henan, China, 473000
        • Not yet recruiting
        • Local Institution - 0128
        • Contact:
          • Site 0128
    • Shaanxi
      • Xi'an, Shaanxi, China, 710126
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
  • France
      • Bobigny, France, 93000
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque
        • Contact:
          • Jean-Frederic Blanc, Site 0056
          • Phone Number: +33556795679
    • Auvergne-Rhône-Alpes
      • La Tronche, Auvergne-Rhône-Alpes, France, 38700
        • Recruiting
        • Centre Hospitalier Universitaire de Grenoble
        • Contact:
          • Thomas Decaens, Site 0004
          • Phone Number: +33476767575
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, France, 42270
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
  • Germany
      • Frankfurt, Germany, D-60590
        • Recruiting
        • Universitaetsklinikum Frankfurt
        • Contact:
          • Joerg Trojan, Site 0030
          • Phone Number: 49(0)69 6301 7860
      • Mainz, Germany, 55101
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein
        • Contact:
          • Jens Marquardt, Site 0028
          • Phone Number: +4945150044101
  • Italy
      • Milan, Italy, 20132
        • Not yet recruiting
        • Local Institution - 0089
        • Contact:
          • Site 0089
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
      • Rozzano (MI), Italy, 20089
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
        • Contact:
          • Ilario Rapposelli, Site 0088
          • Phone Number: 390543739100
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
  • Japan
      • Kashiwa, Japan, 277-8577
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
    • Osaka
      • Osakasayama-shi, Osaka, Japan, 5898511
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • Poland
      • Gdansk, Poland, 80-952
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-439
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-106
        • Not yet recruiting
        • Local Institution - 0105
        • Contact:
          • Site 0105
  • Singapore
      • Singapore, Singapore, 119074
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
      • Singapore, Singapore, 169610
        • Not yet recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Not yet recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05505
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
  • Spain
      • Barcelona, Spain, 8036
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
          • Ana Matilla Pena, Site 0060
          • Phone Number: +34915868308
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Local Institution - 0095
        • Contact:
          • Site 0095
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
  • Taiwan
      • Taichung, Taiwan, 404332
        • Not yet recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Ting-Tsung Chang, Site 0055
          • Phone Number: 88662353535x5389
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Ann-Lii Cheng, Site 0006
          • Phone Number: 8862231234567251
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Yi-Hsiang Huang, Site 0007
          • Phone Number: +886938590872
  • United Kingdom
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • Not yet recruiting
        • Local Institution - 0053
        • Contact:
          • Site 0053
    • London, City of
      • London, London, City of, United Kingdom, W12 0HS
        • Recruiting
        • Hammersmith Hospital
        • Contact:
          • David Pinato, Site 0073
          • Phone Number: 442033131000
    • South Western Scotland
      • Glasgow, South Western Scotland, United Kingdom, G611BD
        • Recruiting
        • Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)
        • Contact:
          • Jeff Evans, Site 0051
          • Phone Number: 441413017073
  • United States
    • California
      • Los Angeles, California, United States, 90064
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Local Institution - 0107
        • Contact:
          • Site 0107
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-2191
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Martin Gutierrez, Site 0103
          • Phone Number: 551-996-5863
    • New York
      • Mineola, New York, United States, 11501
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
          • Binbin Zheng, Site 0080
          • Phone Number: 503-215-3878
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Contact:
          • Binbin Zheng, Site 0111
          • Phone Number: 503-215-3878
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Laura Goff, Site 0102
          • Phone Number: 615-322-4967
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Contact:
          • Jeffery Russell, Site 0022
          • Phone Number: 615-986-0857
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).
  • 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 significant bleeding or coagulation disorders or other obvious bleeding risk evidence.
  • Participants must not have an organ transplant or autoimmune disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1A
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545
Experimental: Cohort 1B
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545
Experimental: Cohort 2A
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545
Experimental: Cohort 2B
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545
Experimental: Cohort 2C
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545
Experimental: Cohort 1A2
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545
Experimental: Cohort 1B2
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BMS-986545

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 25 weeks
Phase 1
Up to approximately 25 weeks
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Time Frame: Up to approximately 25 weeks
Phase 1
Up to approximately 25 weeks
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to day 21
Phase 1
Up to day 21
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 25 weeks
Phase 1
Up to approximately 25 weeks
Number of participants with AEs leading to death
Time Frame: Up to approximately 25 weeks
Phase 1
Up to approximately 25 weeks
Objective response (OR) (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 week 48
Phase 2
Up to week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with AEs
Time Frame: Up to approximately 25 weeks
Phase 2
Up to approximately 25 weeks
Number of participants with SAEs (as per CTCAE v5)
Time Frame: Up to approximately 25 weeks
Phase 2
Up to approximately 25 weeks
Number of participants with treatment-related adverse events (TRAEs)
Time Frame: Up to approximately 25 weeks
Phase 2
Up to approximately 25 weeks
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 25 weeks
Phase 2
Up to approximately 25 weeks
Number of participants with AEs leading to death
Time Frame: Up to approximately 25 weeks
Phase 2
Up to approximately 25 weeks
End of infusion concentration of Pumitamig
Time Frame: Up to day 21
Phase 2
Up to day 21
End of trough concentration of Pumitamig
Time Frame: Up to day 21
Phase 2
Up to day 21
Trough concentration of Ipilimumab
Time Frame: Up to day 21
Phase 2
Up to day 21
Incidence of anti-drug antibodies against Pumitamig
Time Frame: Up to 5 years
Phase 2
Up to 5 years
Incidence of anti-drug antibodies against Ipilimumab
Time Frame: Up to 5 years
Phase 2
Up to 5 years
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Time Frame: Up to 4 years
Phase 2
Up to 4 years
Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment
Time Frame: Up to 4 years
Phase 2
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

BioNTech SE

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

October 15, 2029

Study Completion (Estimated)

October 14, 2031

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA266-0006
  • 2025-523602-33 (Other Identifier: EU CT Number)
  • U1111-1327-4912 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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