Clinical trial · Interventional
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT03298451CI-TRIAL-00119408HIMALAYAactive not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Durvalumab (Regimen 1) | Drug | Durvalumab | ALIAS |
| Durvalumab (Regimen 2) | Drug | Durvalumab | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
| Tremelimumab (Regimen 1) | Drug | Tremelimumab | ALIAS |
| Tremelimumab (Regimen 2) | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Durvalumab
- interventionNames
- Drug: Durvalumab
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Durvalumab in combination with tremelimumab (Regimen 1)
- interventionNames
- Drug: Tremelimumab (Regimen 1)
- Drug: Durvalumab (Regimen 1)
- type
- EXPERIMENTAL
- label
- Arm 3
- description
- Durvalumab in combination with tremelimumab (Regimen 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion criteria * HCC based on histopathological confirmation * No prior systemic therapy for HCC * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C * Child-Pugh Score class A * ECOG performance status of 0 or 1 at enrollment Exclusion criteria * Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy * Clinically meaningful ascites * Main portal vein tumor thrombosis * Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months * HBV and HVC co-infection, or HBV and Hep D co-infection
References
Publications (8)
- DERIVEDRimassa L, Chan SL, Sangro B, Lau G, Kudo M, Reig M, Breder V, Ryu MH, Ostapenko Y, Sukeepaisarnjaroen W, Varela M, Tougeron D, Crysler OV, Bouattour M, Dao TV, Tam VC, Faccio A, Furuse J, Jeng LB, Kang YK, Kelley RK, Kurland JF, Balaji K, Abou-Alfa GK. Plain language summary of five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (liver cancer). Future Oncol. 2026 May;22(12):1359-1372. doi: 10.1080/14796694.2026.2665323. Epub 2026 May 10. PMID 42108643
- DERIVEDChan SL, Kudo M, Sangro B, Kelley RK, Kim JH, Pham B, Hong JY, Waldschmidt DT, Marino D, Joycelyn Lee JX, Gerolami R, Burgoyne AM, Li Q, Nakamura H, Sun P, Baur B, Rimassa L. Early Safety Results from the Phase 3b SIERRA Study of Durvalumab and Tremelimumab as First-Line Treatment for Participants with Unresectable Hepatocellular Carcinoma and a Poor Prognosis. Liver Cancer. 2025 Dec 18. doi: 10.1159/000549955. Online ahead of print. PMID 41585428
- DERIVEDRimassa L, Chan SL, Sangro B, Lau G, Kudo M, Reig M, Breder V, Ryu MH, Ostapenko Y, Sukeepaisarnjaroen W, Varela M, Tougeron D, Crysler OV, Bouattour M, Van Dao T, Tam VC, Faccio A, Furuse J, Jeng LB, Kang YK, Kelley RK, Paskow MJ, Ran D, Xynos I, Kurland JF, Negro A, Abou-Alfa GK. Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. J Hepatol. 2025 Oct;83(4):899-908. doi: 10.1016/j.jhep.2025.03.033. Epub 2025 Apr 11. PMID 40222621
- DERIVEDLau G, Abou-Alfa GK, Cheng AL, Sukeepaisarnjaroen W, Van Dao T, Kang YK, Thungappa SC, Kudo M, Sangro B, Kelley RK, Furuse J, Park JW, Sunpaweravong P, Fasolo A, Yau T, Kawaoka T, Azevedo S, Reig M, Assenat E, Yarchoan M, He AR, Makowsky M, Gupta C, Negro A, Chan SL. Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. J Hepatol. 2025 Feb;82(2):258-267. doi: 10.1016/j.jhep.2024.07.017. Epub 2024 Jul 31. PMID 39089633
- DERIVEDSangro B, Galle PR, Kelley RK, Charoentum C, De Toni EN, Ostapenko Y, Heo J, Cheng AL, Wilson Woods A, Gupta C, Abraham J, McCoy CL, Patel N, Negro A, Vogel A, Abou-Alfa GK. Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2024 Aug 10;42(23):2790-2799. doi: 10.1200/JCO.23.01462. Epub 2024 May 28.