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Clinical Trials in the UK / NCT07291076
Recruiting Phase 1/2

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)

NCT07291076 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1/2
Started
2026-03-16
Last updated
2026-10-23

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Pumitamig →Ipilimumab →

Pumitamig: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of participants with adverse events (AEs) — Up to approximately 25 weeks
    Phase 1
  • Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) — Up to approximately 25 weeks
    Phase 1
  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria — Up to day 21
    Phase 1
  • Number of participants with AEs leading to discontinuation — Up to approximately 25 weeks
    Phase 1
  • Number of participants with AEs leading to death — Up to approximately 25 weeks
    Phase 1
  • Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment — Up to week 48
    Phase 2

Trial sites (67)

FacilityCityRegionStatus
City Of Hope Duarte California Recruiting
Local Institution - 0070 Los Angeles California Not Yet Recruiting
Local Institution - 0107 Chicago Illinois Not Yet Recruiting
Local Institution - 0134 Detroit Michigan Not Yet Recruiting
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Mineola New York Recruiting
Providence Portland Medical Center Portland Oregon Recruiting
Providence St. Vincent Medical Center Portland Oregon Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Local Institution - 0083 Seattle Washington Not Yet Recruiting
Royal Prince Alfred Hospital Camperdown New South Wales Recruiting
Local Institution - 0033 Westmead New South Wales Not Yet Recruiting
Sunshine Coast University Hospital Birtinya Queensland Recruiting
The Royal Melbourne Hospital Parkville Victoria Recruiting
Bradfordhill Santiago Santiago Metropolitan Recruiting
Pontifica Universidad Catolica De Chile Santiago Region Metropolitana Santiago Metropolitan Recruiting
Local Institution - 0122 Hefei Anhui Not Yet Recruiting
Local Institution - 0114 Beijing Beijing Municipality Not Yet Recruiting
Local Institution - 0125 Chongqing Chongqing Municipality Not Yet Recruiting
Local Institution - 0116 Fuzhou Fujian Not Yet Recruiting
Local Institution - 0075 Guangzhou Guangdong Not Yet Recruiting
Local Institution - 0129 Nanning Guangxi Not Yet Recruiting
Local Institution - 0130 Harbin Heilongjiang Not Yet Recruiting
Local Institution - 0128 Nanyang Henan Not Yet Recruiting
Local Institution - 0119 Nanjing Jiangsu Not Yet Recruiting
Local Institution - 0123 Nanchang Jiangxi Not Yet Recruiting
Local Institution - 0115 Xi'an Shaanxi Withdrawn
Local Institution - 0086 Xi'an Shaanxi Not Yet Recruiting
Local Institution - 0118 Jinan Shandong Not Yet Recruiting
Local Institution - 0078 Shanghai Shanghai Municipality Not Yet Recruiting
Local Institution - 0138 Chengdu Sichuan Not Yet Recruiting
Local Institution - 0126 Hangzhou Zhejiang Not Yet Recruiting
CHU Bordeaux Haut-Leveque Pessac Aquitaine Recruiting
Centre Hospitalier Universitaire de Grenoble La Tronche Auvergne-Rhône-Alpes Recruiting
Chu Saint Eloi Montpellier Languedoc-Roussillon Recruiting
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord Saint Priest En Jarez Pays de la Loire Region Recruiting
Hôpital Avicenne Bobigny France Recruiting
Uniklinik Koeln Cologne North Rhine-Westphalia Recruiting
Universitatsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein Recruiting

+ 27 more sites — see the full list on the official registry below.

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A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) Recruiting
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications Recruiting

Other trials for the same condition

International Study on Treatment of Liver (HCC) Patients With IRE Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07291076 on ClinicalTrials.gov ↗ ← All trials in the UK