Hepatocellular Carcinoma (HCC)Phase 1/2NCT07291076

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)

A Phase 1/2 study testing Pumitamig and Ipilimumab in people with Hepatocellular Carcinoma (HCC), run by Bristol-Myers Squibb at 67 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma (HCC)
What is being tested?: Pumitamig and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 67 sitesin 14 countries
Study dates: 16 Mar 2026to 14 Oct 2031
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

67 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Country

City, postcode or hospital

Sites recruiting now only

67 sites in 14 countries

China16 sites, 15 recruiting

Local Institution - 0114
Beijing, Beijing Municipality, 100142
Site 0114
Not yet recruiting
Local Institution - 0138
Chengdu, Sichuan, 610072
Site 0138
Not yet recruiting
Local Institution - 0125
Chongqing, Chongqing Municipality, 400016
Site 0125
Not yet recruiting
Local Institution - 0116
Fuzhou, Fujian, 350028
Site 0116
Not yet recruiting
Local Institution - 0075
Guangzhou, Guangdong, 510515
Site 0075
Not yet recruiting
Local Institution - 0126
Hangzhou, Zhejiang, 310022
Site 0126
Not yet recruiting
Local Institution - 0130
Harbin, Heilongjiang, 150001
Site 0130
Not yet recruiting
Local Institution - 0122
Hefei, Anhui, 230001
Site 0122
Not yet recruiting
Local Institution - 0118
Jinan, Shandong, 250117
Site 0118
Not yet recruiting
Local Institution - 0123
Nanchang, Jiangxi, 330006
Site 0123
Not yet recruiting
Local Institution - 0119
Nanjing, Jiangsu, 210008
Site 0119
Not yet recruiting
Local Institution - 0129
Nanning, Guangxi, 530200
Site 0129
Not yet recruiting
Local Institution - 0128
Nanyang, Henan, 473000
Site 0128
Not yet recruiting
Local Institution - 0078
Shanghai, Shanghai Municipality, 200032
Site 0078
Not yet recruiting
Local Institution - 0115
Xi'an, Shaanxi, 710038
Withdrawn
Local Institution - 0086
Xi'an, Shaanxi, 710126
Site 0086
Not yet recruiting

Other trials in China

United States11 sites, 11 recruiting

Local Institution - 0107
Chicago, Illinois, 60611
Site 0107
Not yet recruiting
Local Institution - 0134
Detroit, Michigan, 48202
Site 0134
Not yet recruiting
City Of Hope
Duarte, California, 91010
Daneng Li, Site 0137, 626-471-9200
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191
Martin Gutierrez, Site 0103, 551-996-5863
Recruiting
Local Institution - 0070
Los Angeles, California, 90064
Site 0070
Not yet recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Mineola, New York, 11501
Kristen Spencer, Site 0100, 732-235-2465
Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Jeffery Russell, Site 0022, 615-986-0857
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Thatcher Heumann, Site 0102, 615-875-6814
Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Binbin Zheng, Site 0080, 503-215-3878
Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Binbin Zheng, Site 0111, 503-215-3878
Recruiting
Local Institution - 0083
Seattle, Washington, 98109-1024
Site 0083
Not yet recruiting

Other trials in United States

France5 sites, 5 recruiting

Hôpital Avicenne
Bobigny, 93000
Pierre Nahon, Site 0003, +33148955555
Recruiting
Centre Hospitalier Universitaire de Grenoble
La Tronche, Auvergne-Rhône-Alpes, 38700
Thomas Decaens, Site 0004, +33476767575
Recruiting
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, 34295
Eric Assenat, Site 0001, +33467336733
Recruiting
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Jean-Frederic Blanc, Site 0056, +33556795679
Recruiting
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, 42270
Jean Phelip, Site 0018, +33477828000
Recruiting

Other trials in France

Australia4 sites, 4 recruiting

Sunshine Coast University Hospital
Birtinya, Queensland, 4575
James O'Beirne, Site 0040, +617520203155
Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Simone Strasser, Site 0024, 61295150056
Recruiting
The Royal Melbourne Hospital
Parkville, Victoria, 3052
Ashok Raj, Site 0096
Recruiting
Local Institution - 0033
Westmead, New South Wales, 2145
Site 0033
Not yet recruiting

Other trials in Australia

Germany4 sites, 4 recruiting

Uniklinik Koeln
Cologne, North Rhine-Westphalia, 50937
Dirk Thomas Waldschmidt, Site 0031, 492214787334
Recruiting
Universitaetsklinikum Frankfurt
Frankfurt, D-60590
Joerg Trojan, Site 0030, 49(0)69 6301 7860
Recruiting
Universitatsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Jens Marquardt, Site 0028, +4945150044101
Recruiting
Universitaetsmedizin Mainz
Mainz, 55101
Friedrich Foerster, Site 0026, +496131175443
Recruiting

Other trials in Germany

Italy4 sites, 4 recruiting

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014
Ilario Rapposelli, Site 0088, 390543739100
Recruiting
Local Institution - 0089
Milan, 20132
Site 0089
Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Caterina Vivaldi, Site 0109, 39050993251
Recruiting
Local Institution - 0016
Pisa, 56126
Site 0016
Not yet recruiting

Other trials in Italy

Spain4 sites, 4 recruiting

Local Institution - 0015
Barcelona, 08036
Site 0015
Not yet recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Ana Matilla Pena, Site 0060, +34915868308
Recruiting
Local Institution - 0095
Madrid, 28050
Site 0095
Not yet recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Bruno Sangro, Site 0014, 0034630957722
Recruiting

Other trials in Spain

Taiwan4 sites, 4 recruiting

China Medical University Hospital
Taichung, 404332
Hung-Wei Wang, Site 0032, 0975681904
Recruiting
National Cheng Kung University Hospital
Tainan, 704
Ting-Tsung Chang, Site 0055, 88662353535x5389
Recruiting
National Taiwan University Hospital
Taipei, 10002
Ann-Lii Cheng, Site 0006, 8862231234567251
Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Yi-Hsiang Huang, Site 0007, +886938590872
Recruiting

Other trials in Taiwan

Poland3 sites, 3 recruiting

Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Piotr Wysocki, Site 0020, +48603347903
Recruiting
Local Institution - 0105
Warsaw, Masovian Voivodeship, 02-106
Site 0105
Not yet recruiting
Local Institution - 0021
Wroclaw, Lower Silesian Voivodeship, 53-439
Site 0021
Not yet recruiting

Other trials in Poland

South Korea3 sites, 3 recruiting

Cha Bundang Medical Center, Cha University
Seongnam-si, Kyǒnggi-do, 13496
Hong Jae Chon, Site 0027, 82317803928
Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Baek-Yeol Ryoo, Site 0011, 82230103211
Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Jung Yong Hong, Site 0013, +82234103459
Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting

Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)
Glasgow, South Western Scotland, G611BD
Jeff Evans, Site 0051, +44 141 330 3953
Recruiting
Hammersmith Hospital
London, London, City of, W12 0HS
David Pinato, Site 0073, +44 20 3313 1000
Recruiting
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
Daniel Palmer, Site 0053, +44 151 556 5000
Recruiting

Other trials in United Kingdom

Chile2 sites, 2 recruiting

Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0064, +56998744662
Recruiting
Pontifica Universidad Catolica De Chile
Santiago Region Metropolitana, Santiago Metropolitan, 8330034
Sebastian Mondaca, Site 0106
Recruiting

Other trials in Chile

Japan2 sites, 2 recruiting

Local Institution - 0008
Kashiwa, 277-8577
Site 0008
Not yet recruiting
Local Institution - 0017
Osakasayama-shi, Osaka, 5898511
Site 0017
Not yet recruiting

Other trials in Japan

Singapore2 sites, 2 recruiting

National University Hospital
Singapore, 119074
Wei Peng Yong, Site 0009, 6567724670
Recruiting
National Cancer Centre Singapore
Singapore, 168583
David Wai Meng Tai, Site 0012, 6564368197
Recruiting

Other trials in Singapore

About this study

Official title: 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)

Conditions: Hepatocellular Carcinoma (HCC)
Being tested: Pumitamig, Ipilimumab
Keywords: First line HCC, Unresectable HCC, Ipilimumab, Pumitamig
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PumitamigDrug
Also called BMS-986545
Specified dose on specified days
IpilimumabDrug
Also called Yervoy
Specified dose on specified days

Study groups in NCT07291076
Study group	Role	What they receive
Cohort 1A	Experimental	Not described Receives: Drug: Pumitamig; Drug: Ipilimumab
Cohort 1B	Experimental	Not described Receives: Drug: Pumitamig; Drug: Ipilimumab
Cohort 2A	Experimental	Not described Receives: Drug: Pumitamig; Drug: Ipilimumab
Cohort 2B	Experimental	Not described Receives: Drug: Pumitamig; Drug: Ipilimumab
Cohort 2C	Experimental	Not described Receives: Drug: Pumitamig
Cohort 1A2	Experimental	Not described Receives: Drug: Pumitamig; Drug: Ipilimumab
Cohort 1B2	Experimental	Not described Receives: Drug: Pumitamig; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202614 Oct 2031

First posted18 Dec 2025
Study start16 Mar 2026
Primary completion15 Oct 2029 (estimated)
Study completion14 Oct 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 198 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07291076
Sponsor's protocol ID: CA266-0006
Other IDs: 2025-523602-33, U1111-1327-4912, 2025
Status last verified: Oct 2026
First submitted: 17 Dec 2025
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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