This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and a TKI compared to double placebo and a TKI in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
Participants receive visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments
Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion
Participants receive the TKI (PO)
Saline (0.9%NaCl) intravenous (2x IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) for up to 35 treatments
Massachusetts General Hospital
Boston, Massachusetts, United States
Progression-free survival (PFS)
Investigator assessed Progression-free survival (PFS) time from randomization (during Safety Run-In: initiation of treatment) to first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first.
Time frame: up to 36 months
Independently assessed PFS by Blinded Independent Central Review (BICR)
Time frame: up to 36 months
CR (Complete Response) rate
Time frame: up to 36 months
PR (Partial Response) rate
Time frame: up to 36 months
ORR (Overall Response) rate
Overall response rate, defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator
Time frame: up to 36 months
TTR (Time-to-response) rate
Time frame: up to 36 months
PFS (Progression-free survival) rate
Time frame: up to 36 months
Participant weight course over time
Time frame: up to 39 months
Adverse Events
Incidence, type and severity of adverse events, treatment emergent adverse events, treatment-related adverse events and serious adverse events
Time frame: up to 60 months
European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC QLQ-C30)
Assess participants' subjective wellbeing
Time frame: up to 39 months
Overall survival (OS)
Time frame: up to 60 months
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