Hepatocellular Carcinoma (HCC)
Conditions
Keywords
First line HCC, Unresectable HCC, Ipilimumab, Pumitamig
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)
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
DRUGAtezolizumab
Specified dose on specified days
DRUGBevacizumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs | Up to approximately 25 weeks | Phase 2 |
| Number of participants with SAEs (as per CTCAE v5) | Up to approximately 25 weeks | Phase 2 |
| Number of participants with treatment-related adverse events (TRAEs) | Up to approximately 25 weeks | Phase 2 |
| Number of participants with AEs leading to discontinuation | Up to approximately 25 weeks | Phase 2 |
| Number of participants with AEs leading to death | Up to approximately 25 weeks | Phase 2 |
| End of infusion concentration of Pumitamig | Up to day 21 | Phase 2 |
| End of trough concentration of Pumitamig | Up to day 21 | Phase 2 |
| Trough concentration of Ipilimumab | Up to day 21 | Phase 2 |
| Incidence of anti-drug antibodies against Pumitamig | Up to 5 years | Phase 2 |
| Incidence of anti-drug antibodies against Ipilimumab | Up to 5 years | Phase 2 |
| Progression-free survival (PFS) by RECIST v1.1 per investigator assessment | Up to 4 years | Phase 2 |
| Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment | Up to 4 years | Phase 2 |
Countries
Australia, Chile, China, France, Germany, Italy, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed