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)

October 22, 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
        • Recruiting
        • Pontifica Universidad Catolica De Chile
        • Contact:
          • Sebastian Mondaca, Site 0106
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • 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
    • Fujian
      • Fuzhou, Fujian, China, 350028
        • Not yet recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Not yet recruiting
        • Local Institution - 0129
        • Contact:
          • Site 0129
    • 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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
    • Shaanxi
      • Xi'an, Shaanxi, China, 710126
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
      • Xi'an, Shaanxi, China, 710038
        • Withdrawn
        • Local Institution - 0115
    • 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
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Local Institution - 0138
        • Contact:
          • Site 0138
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
  • France
      • Bobigny, France, 93000
        • Recruiting
        • Hôpital Avicenne
        • Contact:
          • Pierre Nahon, Site 0003
          • Phone Number: +33148955555
    • 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
        • Recruiting
        • Chu Saint Eloi
        • Contact:
          • Eric Assenat, Site 0001
          • Phone Number: +33467336733
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, France, 42270
        • Recruiting
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
        • Contact:
          • Jean Phelip, Site 0018
          • Phone Number: +33477828000
  • Germany
      • Frankfurt, Germany, D-60590
        • Recruiting
        • Universitaetsklinikum Frankfurt
        • Contact:
          • Joerg Trojan, Site 0030
          • Phone Number: 49(0)69 6301 7860
      • Mainz, Germany, 55101
        • Recruiting
        • Universitaetsmedizin Mainz
        • Contact:
          • Friedrich Foerster, Site 0026
          • Phone Number: +496131175443
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Uniklinik Koeln
        • Contact:
          • Dirk Thomas Waldschmidt, Site 0031
          • Phone Number: 492214787334
    • 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
    • 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
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
          • Caterina Vivaldi, Site 0109
          • Phone Number: 39050993251
  • 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
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Contact:
          • Piotr Wysocki, Site 0020
          • Phone Number: +48603347903
    • 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
        • Recruiting
        • National University Hospital
        • Contact:
          • Wei Peng Yong, Site 0009
          • Phone Number: 6567724670
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:
          • David Wai Meng Tai, Site 0012
          • Phone Number: 6564368197
  • South Korea
    • Kyǒnggi-do
      • Seongnam-si, Kyǒnggi-do, South Korea, 13496
        • Recruiting
        • Cha Bundang Medical Center, Cha University
        • Contact:
          • Hong Jae Chon, Site 0027
          • Phone Number: 82317803928
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Jung Yong Hong, Site 0013
          • Phone Number: +82234103459
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Baek-Yeol Ryoo, Site 0011
          • Phone Number: 82230103211
  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Local Institution - 0095
        • Contact:
          • Site 0095
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Ana Matilla Pena, Site 0060
          • Phone Number: +34915868308
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Bruno Sangro, Site 0014
          • Phone Number: 0034630957722
  • Taiwan
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Hung-Wei Wang, Site 0032
          • Phone Number: 0975681904
      • 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
        • Recruiting
        • The Clatterbridge Cancer Centre
        • Contact:
          • Daniel Palmer, Site 0053
          • Phone Number: +44 151 556 5000
    • London, City of
      • London, London, City of, United Kingdom, W12 0HS
        • Recruiting
        • Hammersmith Hospital
        • Contact:
          • David Pinato, Site 0073
          • Phone Number: +44 20 3313 1000
    • 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: +44 141 330 3953
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City Of Hope
        • Contact:
          • Daneng Li, Site 0137
          • Phone Number: 626-471-9200
      • 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
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
    • 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
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Contact:
          • Kristen Spencer, Site 0100
          • Phone Number: 732-235-2465
    • 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:
          • Thatcher Heumann, Site 0102
          • Phone Number: 615-875-6814
      • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Drug: Ipilimumab

Specified dose on specified days

Other Names:
  • Yervoy
Experimental: Cohort 1B
Drug: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Drug: Ipilimumab

Specified dose on specified days

Other Names:
  • Yervoy
Experimental: Cohort 2A
Drug: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Drug: Ipilimumab

Specified dose on specified days

Other Names:
  • Yervoy
Experimental: Cohort 2B
Drug: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Drug: Ipilimumab

Specified dose on specified days

Other Names:
  • Yervoy
Experimental: Cohort 2C
Drug: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Experimental: Cohort 1A2
Drug: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Drug: Ipilimumab

Specified dose on specified days

Other Names:
  • Yervoy
Experimental: Cohort 1B2
Drug: Pumitamig

Specified dose on specified days

Other Names:
  • BMS-986545
Drug: Ipilimumab

Specified dose on specified days

Other Names:
  • Yervoy

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)

October 23, 2026

Last Update Submitted That Met QC Criteria

October 22, 2026

Last Verified

October 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)
  • 2025 (U.S. NIH Grant/Contract)

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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