A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with advanced Hepatocellular Carcinoma (HIMALAYA)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512212-21-00

Acronym

D419CC00002

Enrollment

302

Registered

2024-07-12

Start date

2017-11-28

Completion date

Unknown

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced hepatocellular carcinoma (HCC)

Brief summary

Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.

Detailed description

Progression-free survival (PFS), Time to progression (TTP), Objective response rate (ORR), Disease control rate (DCR), and Duration of response (DoR)

Interventions

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

DRUGMycophenolate Mofetil 500 mg film-coated tablets

DRUGNexavar 200 mg film-coated tablets

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGInflectra 100 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.	—

Secondary

Measure	Time frame
Progression-free survival (PFS), Time to progression (TTP), Objective response rate (ORR), Disease control rate (DCR), and Duration of response (DoR)	—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026