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 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA266-00062025-523602-33U1111-1327-4912
• Study Type: interventional
• Target: 129
• Locations: 13 countries
• Sites: 46

Brief 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)

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

First line HCC; Unresectable HCC; Ipilimumab; Pumitamig

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events (AEs)

  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))

  Phase 1

  Up to approximately 25 weeks

• Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

  Phase 1

  Up to day 21

• Number of participants with AEs leading to discontinuation

  Phase 1

  Up to approximately 25 weeks

• Number of participants with AEs leading to death

  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

  Phase 2

  Up to week 48

Secondary Outcomes (12)

• Number of participants with AEs

  Up to approximately 25 weeks

• Number of participants with SAEs (as per CTCAE v5)

  Up to approximately 25 weeks

• Number of participants with treatment-related adverse events (TRAEs)

  Up to approximately 25 weeks

• Number of participants with AEs leading to discontinuation

  Up to approximately 25 weeks

• Number of participants with AEs leading to death

  Up to approximately 25 weeks

Study Arms (6)

Cohort 1A

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Cohort 1B

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Cohort 2A

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Cohort 2B

EXPERIMENTAL

Drug: Pumitamig; Drug: Ipilimumab

Cohort 2C

OTHER

Drug: Atezolizumab; Drug: Bevacizumab

Cohort 2D

EXPERIMENTAL

Drug: Pumitamig

Interventions

Pumitamig DRUG

Specified dose on specified days

Also known as: BMS-986545

Cohort 1A; Cohort 1B; Cohort 2A; Cohort 2B; Cohort 2D

Ipilimumab DRUG

Specified dose on specified days

Also known as: Yervoy

Cohort 1A; Cohort 1B; Cohort 2A; Cohort 2B

Atezolizumab DRUG

Specified dose on specified days

Cohort 2C

Bevacizumab DRUG

Specified dose on specified days

Cohort 2C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• BioNTech SE: collaborator

Study Sites (46)

Local Institution - 0070

Los Angeles, California, 90064, United States

NOT YET RECRUITING

Local Institution - 0107

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Local Institution - 0100

Mineola, New York, 11501, United States

NOT YET RECRUITING

Local Institution - 0080

Portland, Oregon, 97213, United States

NOT YET RECRUITING

Local Institution - 0111

Portland, Oregon, 97225, United States

NOT YET RECRUITING

Local Institution - 0022

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Local Institution - 0102

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Local Institution - 0083

Seattle, Washington, 98109-1024, United States

NOT YET RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Local Institution - 0033

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Local Institution - 0040

Birtinya, Queensland, 4575, Australia

NOT YET RECRUITING

Local Institution - 0096

Melbourne, 3002, Australia

NOT YET RECRUITING

Local Institution - 0064

Santiago, Santiago Metropolitan, 8420383, Chile

NOT YET RECRUITING

Local Institution - 0106

Santiago Region Metropolitana, Santiago Metropolitan, 8330034, Chile

NOT YET RECRUITING

Local Institution - 0075

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

Local Institution - 0086

Xi'an, Shaanxi, 710126, China

NOT YET RECRUITING

Local Institution - 0078

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Local Institution - 0056

Pessac, Aquitaine, 33600, France

NOT YET RECRUITING

Local Institution - 0004

Grenoble, Isère, 38043, France

NOT YET RECRUITING

Local Institution - 0018

Saint Priest En Jarez, Pays de la Loire Region, 42270, France

NOT YET RECRUITING

Local Institution - 0003

Bobigny, 93000, France

NOT YET RECRUITING

Local Institution - 0031

Cologne, North Rhine-Westphalia, 50937, Germany

NOT YET RECRUITING

Local Institution - 0028

Kiel, Schleswig-Holstein, 24105, Germany

NOT YET RECRUITING

Local Institution - 0030

Frankfurt, D-60590, Germany

NOT YET RECRUITING

Local Institution - 0109

Pisa, Tuscany, 56126, Italy

NOT YET RECRUITING

Local Institution - 0088

Milan, 20, Italy

NOT YET RECRUITING

Local Institution - 0016

Pisa, 56126, Italy

NOT YET RECRUITING

Local Institution - 0046

Rozzano (MI), 20089, Italy

NOT YET RECRUITING

Local Institution - 0021

Wroclaw, Lower Silesian Voivodeship, 53-439, Poland

NOT YET RECRUITING

Local Institution - 0105

Warsaw, Masovian Voivodeship, 02-106, Poland

NOT YET RECRUITING

Local Institution - 0020

Gdansk, 80-952, Poland

NOT YET RECRUITING

Local Institution - 0009

Singapore, 119074, Singapore

NOT YET RECRUITING

Local Institution - 0012

Singapore, 169610, Singapore

NOT YET RECRUITING

Local Institution - 0027

Seongnam-si, Gyeonggi-do, 13496, South Korea

NOT YET RECRUITING

Local Institution - 0013

Seoul, Seoul Teugbyeolsi, 06351, South Korea

NOT YET RECRUITING

Local Institution - 0011

Seoul, Seoul-teukbyeolsi, 05505, South Korea

NOT YET RECRUITING

Local Institution - 0014

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Local Institution - 0060

Madrid, 28028, Spain

NOT YET RECRUITING

Local Institution - 0032

Taichung, 404332, Taiwan

NOT YET RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Local Institution - 0006

Taipei, 100229, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Hammersmith Hospital

London, London, City of, W12 0HS, United Kingdom

RECRUITING

Local Institution - 0051

Glasgow, South Western Scotland, G611BD, United Kingdom

NOT YET RECRUITING

Local Institution - 0053

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Ipilimumab; atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 18, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): October 14, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

TW (4); CL (2); US (9); PL (3); CN (3); IT (4); AU (4); KR (3); DE (3); SG (2); GB (3); ES (2); FR (4)