A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05908786
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1.
  • Tiragolumab — DRUG
    Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1.
  • Tobemstomig — DRUG
    Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1

Study Details

This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

Key Dates

Start date
Dec 5, 2023
Status verified
Dec 2025
Primary completion
Aug 27, 2025
Completion
Nov 13, 2025

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezo + Bev
    Participants in the atezolizumab plus bevacizumab (Atezo + Bev) arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.
  • Experimental: Atezo + Bev +Tira
    Participants in the atezolizumab plus bevacizumab plus tiragolumab (Atezo + Bev +Tira) arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.
  • Experimental: Tobe + Bev
    Participants in the Tobemstomig + Bev arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first. Enrollment is closed.

Primary Outcome Measure

Major Pathologic Response (MPR) Rate [ Time Frame: At the time of surgery ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Southern California (USC)Los AngelesCalifornia90033-
University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaSanta MonicaCalifornia90404-2023-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main CampusDetroitMichigan48201-2013-
Columbia University Medical CenterNew YorkNew York10032-
UT Southwestern Medical CenterDallasTexas75390-8813-

Find similar trials in Los Angeles, CA

By research site
University of Southern California (USC)· Los Angeles, CAUniversity of California Los Angeles (UCLA) - Cancer Care - Santa Monica· Santa Monica, CAGeorgetown University Medical Center· Washington D.C., DCBarbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus· Detroit, MIColumbia University Medical Center· New York, NYUT Southwestern Medical Center· Dallas, TX

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