Erudio Healtherudio.com
Clinical trial · no report yet · Phase 3
HIMALAYA
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- NCT03298451 ↗
- Active, not recruiting
- AstraZeneca
- Focused
We haven't built an HCP commentary report on HIMALAYA (tremelimumab plus durvalumab; durvalumab in first-line unresectable hepatocellular carcinoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on HIMALAYA so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 2 | |
| YouTube | 1 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Durvalumab; Tremelimumab (Regimen 1); Tremelimumab (Regimen 2); Sorafenib; Durvalumab (Regimen 1); Durvalumab (Regimen 2)
- Arms
- Arm 1 · Experimental
- Arm 2 · Experimental
- Arm 3 · Experimental
- Arm 4 · Active comparator
- Enrollment
- 1,324
- Primary outcomes
- Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
- Sponsor
- AstraZeneca
- Start
- Oct 11, 2017
- Primary completion
- Aug 27, 2021
- Results posted
- Yes
- Registry record
- NCT03298451 · updated Oct 7, 2026
Publications
linked from the registry- Rimassa 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. PubMed 42108643
- Chan 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. PubMed 41585428
- Rimassa 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. PubMed 40222621
- Lau 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. PubMed 39089633
- Sangro 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. PubMed 38805668
- Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, Sukeepaisarnjaroen W, Kang YK, Van Dao T, De Toni EN, Rimassa L, Breder V, Vasilyev A, Heurgue A, Tam VC, Mody K, Thungappa SC, Ostapenko Y, Yau T, Azevedo S, Varela M, Cheng AL, Qin S, Galle PR, Ali S, Marcovitz M, Makowsky M, He P, Kurland JF, Negro A, Sangro B. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022 Aug;1(8):EVIDoa2100070. doi: 10.1056/EVIDoa2100070. Epub 2022 Jun 6. PubMed 38319892
- Addendum 1: Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of hepatocellular carcinoma. J Immunother Cancer. 2023 Sep;11(9):e002794add1. doi: 10.1136/jitc-2021-002794add1. No abstract available. PubMed 37678916
- Patel TH, Brewer JR, Fan J, Cheng J, Shen YL, Xiang Y, Zhao H, Lemery SJ, Pazdur R, Kluetz PG, Fashoyin-Aje LA. FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma. Clin Cancer Res. 2024 Jan 17;30(2):269-273. doi: 10.1158/1078-0432.CCR-23-2124. PubMed 37676259