Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT03298451 · HIMALAYA Phase 3Active, not recruiting
- Lead sponsor
- AstraZeneca (Industry)
- Enrollment
- 1,324 (actual)
- Start date
- 11 Oct 2017
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 31 Dec 2027
- Last update posted
- 7 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 4
Interventions
- Durvalumab Drug
- Tremelimumab (Regimen 1) Drug
- Tremelimumab (Regimen 2) Drug
- Sorafenib Drug
- Durvalumab (Regimen 1) Drug
- Durvalumab (Regimen 2) Drug
Conditions and primary outcome
- Hepatocellular Carcinoma
Primary outcome
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg (From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03298451 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
- Time frame
- From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).
- Measure
- Median
- Unit
- months
Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mgSuperiority
The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.
- Estimate
- Not given
- CI
- Not given
- p-value
- 0.0035
- Method
- Log Rank
Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mgSuperiority
The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.
- Estimate
- 0.78Hazard Ratio (HR)
- 95% CI, two-sided
- 0.66 to 0.92
- p-value
- Not given
- Method
- Regression, Cox
Serious adverse events
Time frame: All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
| Group | Affected | At risk |
|---|---|---|
| Durva 1500 mg | 115 | 388 |
| Treme 300 mg x1 Dose + Durva 1500 mg | 157 | 388 |
| Treme 75 mg x4 Doses + Durva 1500 mg | 52 | 152 |
| Sora 400 mg | 111 | 374 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
8 on PubMedPlain language summary of five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (liver cancer).
Future oncology (London, England) · 2026 May
PubMed 42108643 (opens in a new tab)DOI 10.1080/14796694.2026.2665323 (opens in a new tab)
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
PubMed 41585428 (opens in a new tab)DOI 10.1159/000549955 (opens in a new tab)
Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC.
Journal of hepatology · 2025 Oct
PubMed 40222621 (opens in a new tab)DOI 10.1016/j.jhep.2025.03.033 (opens in a new tab)
Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.
Journal of hepatology · 2025 Feb
PubMed 39089633 (opens in a new tab)DOI 10.1016/j.jhep.2024.07.017 (opens in a new tab)
Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 Aug 10
PubMed 38805668 (opens in a new tab)DOI 10.1200/JCO.23.01462 (opens in a new tab)
FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma.
Clinical cancer research : an official journal of the American Association for Cancer Research · 2024 Jan 17
PubMed 37676259 (opens in a new tab)DOI 10.1158/1078-0432.CCR-23-2124 (opens in a new tab)
Addendum 1: Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of hepatocellular carcinoma.
Journal for immunotherapy of cancer · 2023 Sep
PubMed 37678916 (opens in a new tab)DOI 10.1136/jitc-2021-002794add1 (opens in a new tab)
Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma.
NEJM evidence · 2022 Aug
PubMed 38319892 (opens in a new tab)DOI 10.1056/EVIDoa2100070 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
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Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03298451 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.