NCT07291076|RecruitingPhase 1FDA Drug

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)

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)

Bristol-Myers Squibb ClinicalTrials.gov

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3 other identifiers

CA266-00062025-523602-33U1111-1327-4912

Study Type

interventional

Target

198

Locations

14 countries

Sites

Timeline

RegisteredDec 2025

StartedMar 2026

CompletionOct 2031

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)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

198

participants targeted

Target at P75+ for phase_1

Timeline

65mo left

Started Mar 2026

Longer than P75 for phase_1

Geographic Reach

14 countries

59 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

Study Progress4%

Mar 2026Oct 2031

First Submitted

Initial submission to the registry

December 17, 2025

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed

3 months until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2029

Expected

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2031

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

December 17, 2025

Last Update Submit

May 29, 2026

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

First line HCCUnresectable HCCIpilimumabPumitamig

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
+7 more secondary outcomes