Immunotherapy for Liver Cancer

(HIMALAYA Trial)

Recruiting at157 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

Research Team

Eligibility Criteria

This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic therapy before and can't have targeted local treatments. They should be in relatively good health (Child-Pugh A, ECOG 0 or 1). People with serious fluid buildup in the abdomen, major blood vessel blockage by the tumor, certain viral infections, recent brain issues related to liver disease, or a history of significant GI bleeding can't join.

Inclusion Criteria

My liver cancer diagnosis was confirmed through tissue examination.

My liver function is good.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

HBV and HVC co-infection, or HBV and Hep D co-infection

I have not had brain function issues due to liver disease in the last year.

I have a blood clot in the main vein of my liver caused by cancer.

Treatment Details

Interventions

• Durvalumab (Checkpoint Inhibitor)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview The study compares three approaches: one group gets Durvalumab plus Tremelimumab; another gets just Durvalumab; and a third receives Sorafenib. It's designed to see which treatment is better as a first-line option for unresectable Hepatocellular Carcinoma.

Participant Groups

Group I: Arm 3 Experimental Treatment 2 Interventions

Durvalumab in combination with tremelimumab (Regimen 2)

Group II: Arm 2 Experimental Treatment 2 Interventions

Durvalumab in combination with tremelimumab (Regimen 1)

Group III: Arm 1 Experimental Treatment 1 Intervention

Durvalumab

Group IV: Arm 4 Active Control 1 Intervention

Sorafenib

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology