Health Trials

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)

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • Pumitamig
  • Ipilimumab

Treatment groups

198 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

64
Australia
Royal Prince Alfred Hospital2050, CamperdownNew South Wales, Australia
Local Institution - 00332145, WestmeadNew South Wales, Australia
Sunshine Coast University Hospital4575, BirtinyaQueensland, Australia
The Royal Melbourne Hospital3052, ParkvilleVictoria, Australia

Sponsors and collaborators

Bristol-Myers Squibb

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov