Active, not recruitingNCT03298451HIMALAYAUpdated Jul 27, 2026Results posted

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

A Phase 3 interventional study of Durvalumab and Tremelimumab (Regimen 1) in Hepatocellular Carcinoma, sponsored by AstraZeneca. Active, not recruiting at 160 sites in 17 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,324
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study summary

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

Read the detailed description

The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC.

Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression

Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment.

If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival

Conditions studied

Hepatocellular Carcinoma

Browse trials for

Carcinoma, Hepatocellular 3,174

Keywords

Hepatocellular Carcinoma Non-Resectable

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,324 participants (actual)

Study arms

Experimental
Arm 1
Durvalumab
Drug: Durvalumab
Experimental
Arm 2
Durvalumab in combination with tremelimumab (Regimen 1)
Drug: Tremelimumab (Regimen 1) · Drug: Durvalumab (Regimen 1)
Experimental
Arm 3
Durvalumab in combination with tremelimumab (Regimen 2)
Drug: Tremelimumab (Regimen 2) · Drug: Durvalumab (Regimen 2)
Active comparator
Arm 4
Sorafenib
Drug: Sorafenib

Interventions

DrugDurvalumab
Durvalumab IV (intravenous infusion).
Also known as: MEDI4736
DrugTremelimumab (Regimen 1)
Tremelimumab IV (intravenous infusion).
DrugTremelimumab (Regimen 2)
Tremelimumab IV (intravenous infusion).
DrugSorafenib
Sorafenib, as per standard of care
DrugDurvalumab (Regimen 1)
Durvalumab IV (intravenous infusion).
DrugDurvalumab (Regimen 2)
Durvalumab IV (intravenous infusion).

What researchers measure

Primary outcomes

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).
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).

Secondary outcomes

Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg
OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).
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).
Overall Survival (OS) at 18, 24, and 36 Months After Randomization
Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.
Time frame: At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).
Progression Free Survival (PFS)
PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the patient withdrew from study treatment or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as a at least 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.
Time frame: Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)
Time To Progression (TTP)
TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.
Time frame: From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Objective Response Rate (ORR)
ORR (per RECIST 1.1 as assessed by the Investigator) was defined as the number (%) of participants with at least 1 confirmed visit response of CR or PR until progression, or the last evaluable assessment in the absence of progression. Participants who go off treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.
Time frame: From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Disease Control Rate (DCR)
Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.
Time frame: From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Duration of Objective Response (DoR)
Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.
Time frame: From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Overall Survival (OS) by PD-L1
Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP \< 1%).
Time frame: From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration
European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.
Time frame: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration
EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.
Time frame: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration
EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.
Time frame: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration
EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.
Time frame: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
Presence of ADA for Durvalumab
Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.
Time frame: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Presence of ADA for Tremelimumab
Number of participants with Anti-Drug Antibody (ADA) response to Tremelimumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Tremelimumab for each indicated category.
Time frame: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.
Summary of Durvalumab Concentration Over Time
Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.
Time frame: To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).
Summary of Tremelimumab Concentration Over Time
Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.
Time frame: To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).

Results

Posted Jun 18, 2023

Participant flow

The study includes 1324 participants. Participants were screened in 16 countries from Oct2017 to Jun2019. Recruitment in T75+D arm was closed during the study. Results are reported at data cut-off (DCO).

Participant flow — Overall Study
Milestone	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Started	389	393	153	389
Received treatment	386	389	153	374
Completed	104	125	30	82
Not completed	285	268	123	307
Withdrew: Death	275	260	122	280
Withdrew: Lost to follow-up	1	1	0	7
Withdrew: Withdrawal by subject	9	7	1	20

Outcome measures

PrimaryOverall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

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).
Reported as:: Median · months

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg	16.56 (14.06 to 19.12)	16.43 (14.16 to 19.58)	16.36 (12.39 to 19.65)	13.77 (12.25 to 16.13)

Statistical analysis

Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg · Log Rank · p = 0.0035 (The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.)
Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg · Regression, Cox · Hazard ratio (hr): 0.78 · 95% CI 0.66 to 0.92

SecondaryOverall Survival (OS) - Durva 1500 mg vs Sora 400 mg

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

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).
Reported as:: Median · months

Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg	16.56 (14.06 to 19.12)	16.43 (14.16 to 19.58)	16.36 (12.39 to 19.65)	13.77 (12.25 to 16.13)

Statistical analysis

Durva 1500 mg vs Sora 400 mg · Regression, Cox · Hazard ratio (hr): 0.86 · 95.67% CI 0.73 to 1.03The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.
Durva 1500 mg vs Sora 400 mg · Log Rank · p = 0.0674 (The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.)

SecondaryOverall Survival (OS) at 18, 24, and 36 Months After Randomization

Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.

Time frame:: At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).
Reported as:: Number · percentage of survival

Overall Survival (OS) at 18, 24, and 36 Months After Randomization
percentage of survival	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Survival rate at 18 months	47.4 (42.4 to 52.3)	48.7 (43.6 to 53.5)	46.4 (38.4 to 54.1)	41.5 (36.5 to 46.4)
Survival rate at 24 months	39.6 (34.8 to 44.5)	40.5 (35.6 to 45.3)	37.3 (29.6 to 44.9)	32.6 (27.9 to 37.4)
Survival rate at 36 months	24.7 (20.0 to 29.8)	30.7 (25.8 to 35.7)	22.9 (16.6 to 29.8)	20.2 (15.8 to 25.1)

SecondaryProgression Free Survival (PFS)

PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the patient withdrew from study treatment or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as a at least 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.

Time frame:: Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)
Reported as:: Median · months

Progression Free Survival (PFS)
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Progression Free Survival (PFS)	3.65 (3.19 to 3.75)	3.78 (3.68 to 5.32)	3.65 (2.79 to 4.86)	4.07 (3.75 to 5.49)

SecondaryTime To Progression (TTP)

TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.

Time frame:: From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Reported as:: Median · months

Time To Progression (TTP)
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Time To Progression (TTP)	3.75 (3.68 to 5.42)	5.42 (3.81 to 5.62)	3.75 (3.55 to 5.59)	5.55 (5.13 to 5.75)

SecondaryObjective Response Rate (ORR)

ORR (per RECIST 1.1 as assessed by the Investigator) was defined as the number (%) of participants with at least 1 confirmed visit response of CR or PR until progression, or the last evaluable assessment in the absence of progression. Participants who go off treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Time frame:: From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Reported as:: Count of participants · Participants

Objective Response Rate (ORR)
Participants	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Objective Response Rate (ORR)	66	79	26	20

SecondaryDisease Control Rate (DCR)

Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.

Time frame:: From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Reported as:: Count of participants · Participants

Disease Control Rate (DCR)
Participants	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Yes	213	236	89	236
No	176	157	64	153

SecondaryDuration of Objective Response (DoR)

Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Time frame:: From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Reported as:: Median · months

Duration of Objective Response (DoR)
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Duration of response from onset of response	16.82 (7.43 to NA)	22.34 (8.54 to NA)	14.75 (7.46 to 14.75)	18.43 (6.51 to 25.99)
Time to onset of response from randomization	2.09 (1.87 to 3.98)	2.17 (1.84 to 3.98)	2.02 (1.87 to 3.71)	3.78 (1.89 to 8.44)

SecondaryOverall Survival (OS) by PD-L1

Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP \< 1%).

Time frame:: From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Reported as:: Median · months

Overall Survival (OS) by PD-L1
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
PD-L1 expression positive (TIP>=1%)	17.22 (12.29 to 24.38)	17.00 (13.11 to 22.31)	24.21 (14.55 to 27.24)	15.93 (10.68 to 21.72)
PD-L1 expression negative (TIP<1%)	15.06 (12.68 to 18.53)	14.26 (11.50 to 21.29)	14.46 (8.97 to 17.51)	13.93 (12.39 to 16.69)

SecondaryEORTC QLQ-C30 Time to Global Health Status/QoL Deterioration

European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Time frame:: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
Reported as:: Median · months

EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration	7.4 (5.68 to 9.33)	7.5 (5.82 to 10.84)	7.3 (5.65 to 9.33)	5.7 (4.80 to 7.39)

SecondaryEORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration

EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Time frame:: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
Reported as:: Median · months

EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration	14.1 (9.46 to 24.41)	16.8 (11.17 to NA)	14.7 (8.97 to 36.04)	8.9 (7.23 to 11.14)

SecondaryEORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration

Time frame:: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
Reported as:: Median · months

EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration	16.0 (9.03 to 22.31)	12.6 (9.23 to 19.58)	13.8 (6.47 to 19.19)	9.4 (7.46 to 13.37)

SecondaryEORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration

Time frame:: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.
Reported as:: Median · months

EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration
months	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration	16.7 (9.46 to 24.8)	20.9 (12.88 to 36.01)	11.3 (5.78 to 19.19)	11.1 (9.26 to 13.73)

SecondaryPresence of ADA for Durvalumab

Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.

Time frame:: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Reported as:: Count of participants · Participants

Presence of ADA for Durvalumab
Participants	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Treatment-emergent ADA positive (ADA Incidence)	8	9	5	—
Treatment-induced ADA (Positive Post-baseline only)	7	9	5	—

SecondaryPresence of ADA for Tremelimumab

Number of participants with Anti-Drug Antibody (ADA) response to Tremelimumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Tremelimumab for each indicated category.

Time frame:: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.
Reported as:: Count of participants · Participants

Presence of ADA for Tremelimumab
Participants	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Treatment-emergent ADA positive (ADA Incidence)	—	20	23	—
Treatment-induced ADA (Positive Post-baseline only)	—	20	22	—

SecondarySummary of Durvalumab Concentration Over Time

Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.

Time frame:: To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).
Reported as:: Geometric mean · ug/mL

Summary of Durvalumab Concentration Over Time
ug/mL	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Cycle 2 (Week 4) pre-dose, Geometric mean	74.7 ± 86.7	59.9 ± 101.6	65.1 ± 68.4	—
Cycle 4 (Week 12) pre-dose, Geometric mean	113.9 ± 116.2	77.5 ± 280.1	92.1 ± 137.5	—
Cycle 4 (Week 12) post-dose, Geometric mean	556.9 ± 32.7	539.3 ± 38.6	528.4 ± 36.8	—

SecondarySummary of Tremelimumab Concentration Over Time

Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.

Time frame:: To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).
Reported as:: Geometric mean · ug/mL

Summary of Tremelimumab Concentration Over Time
ug/mL	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Cycle 1 (Week 0) post-dose, Geometric mean	—	78.0 ± 117.2	—	—
Cycle 2 (Week 4), Geometric mean	—	10.7 ± 84.7	3.2 ± 67.8	—
Cycle 4 (Week 12), Geometric mean	—	1.3 ± 156.5	4.3 ± 85.4	—

Adverse events

Collected over All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Durva 1500 mg	280/389 (72%)	115/388 (29.6%)	299/388 (77.1%)
Treme 300 mg x1 Dose + Durva 1500 mg	262/393 (66.7%)	157/388 (40.5%)	334/388 (86.1%)
Treme 75 mg x4 Doses + Durva 1500 mg	123/153 (80.4%)	52/152 (34.2%)	133/152 (87.5%)
Sora 400 mg	293/389 (75.3%)	111/374 (29.7%)	333/374 (89%)

Most frequent serious events

Showing 10 of 290

Most frequent serious events
Event	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
PneumoniaInfections and infestations	3/388	7/388	6/152	8/374
DeathGeneral disorders	8/388	4/388	5/152	5/374
DiarrhoeaGastrointestinal disorders	2/388	9/388	4/152	6/374
HepatitisHepatobiliary disorders	1/388	3/388	4/152	0/374
SepsisInfections and infestations	4/388	8/388	2/152	0/374
AnaemiaBlood and lymphatic system disorders	1/388	5/388	3/152	2/374
Oesophageal varices haemorrhageGastrointestinal disorders	4/388	1/388	3/152	2/374
PneumonitisRespiratory, thoracic and mediastinal disorders	2/388	4/388	3/152	1/374
Upper gastrointestinal haemorrhageGastrointestinal disorders	1/388	7/388	0/152	4/374
Gastrointestinal haemorrhageGastrointestinal disorders	5/388	7/388	0/152	3/374

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg
Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders	1/388	3/388	3/152	173/374
DiarrhoeaGastrointestinal disorders	57/388	97/388	28/152	164/374
PruritusSkin and subcutaneous tissue disorders	56/388	89/388	27/152	24/374
RashSkin and subcutaneous tissue disorders	39/388	84/388	27/152	50/374
FatigueGeneral disorders	37/388	65/388	25/152	70/374
HypertensionVascular disorders	17/388	22/388	6/152	68/374
Decreased appetiteMetabolism and nutrition disorders	53/388	65/388	24/152	67/374
Abdominal painGastrointestinal disorders	35/388	44/388	24/152	59/374
AlopeciaSkin and subcutaneous tissue disorders	5/388	2/388	1/152	53/374
Aspartate aminotransferase increasedInvestigations	54/388	46/388	16/152	24/374

Baseline characteristics

The full analysis set (FAS) included all participants who were randomized.

Age, Continuous
Age, Continuous(years)	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg	Total
Mean	62.6 ± 11.47	63.0 ± 11.65	63.4 ± 12.03	63.5 ± 11.12	63.1 ± 11.48

Age, Customized
Age, Customized(Participants)	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg	Total
<65	203	195	74	195	667
>=65-<75	130	145	55	137	467
>=75	56	53	24	57	190

Sex: Female, Male
Sex: Female, Male(Participants)	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg	Total
Female	66	66	32	52	216
Male	323	327	121	337	1108

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg	Total
White	160	182	70	179	591
Black or African American	2	7	4	10	23
Asian	212	195	75	189	671
Native Hawaiian or other Pacific Islander	0	1	0	0	1
American Indian or Alaska Native	0	0	0	0	0
Other	15	7	4	5	31
Missing	0	1	0	6	7

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg	Total
Hispanic or Latino	13	21	11	21	66
Not Hispanic or Latino	376	372	142	362	1252
Missing	0	0	0	6	6

Region group
Region group(Participants)	Durva 1500 mg	Treme 300 mg x1 Dose + Durva 1500 mg	Treme 75 mg x4 Doses + Durva 1500 mg	Sora 400 mg	Total
Asia (except Japan)	167	156	60	156	539
Rest of World (includes Japan)	222	237	93	233	785

Study locations

160 sites

Research Site
Los Angeles, California 90048, United States
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Orange, California 92868, United States
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San Francisco, California 94158, United States
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Washington D.C., District of Columbia 20007, United States
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Fort Myers, Florida 33916, United States
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Jacksonville, Florida 32224, United States
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Westwood, Kansas 66205, United States
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Baltimore, Maryland 21231, United States
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Ann Arbor, Michigan 48109, United States
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Rochester, Minnesota 55905, United States
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New York, New York 10065, United States
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Charlotte, North Carolina 28262, United States
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Portland, Oregon 97213, United States
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Pittsburgh, Pennsylvania 15237, United States
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Dallas, Texas 74235, United States
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Dallas, Texas 75216, United States
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Dallas, Texas 75235, United States
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Houston, Texas 77030, United States
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Houston, Texas 77090, United States
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Murray, Utah 84107, United States
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Barretos, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Calgary, Alberta T2N 4N2, Canada
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Edmonton, Alberta T6G 1Z2, Canada
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Hamilton, Ontario L8V 5C2, Canada
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Kingston, Ontario K7L 2V7, Canada
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London, Ontario N6A 4L6, Canada
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Toronto, Ontario M4N 3M5, Canada
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Montreal, Quebec H2X 0A9, Canada
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Québec, Quebec G1R 2J6, Canada
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Sherbrooke, Quebec J1H 5N4, Canada
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Dalian, China
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Fuzhou, China
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Guangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Nanchang, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Suzhou, China
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Wuhan, China
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Xi'an, China
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Zhengzhou, China
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Clichy, France
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Lille, France
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Marseille, France
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Montpellier, France
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Nancy, France
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Nantes, France
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Nice, France
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Pessac, France
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Poitiers, France
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Reims, France
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Rouen, France
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Saint-Etienne, France
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Toulouse, France
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Villejuif, France
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Aachen, Germany
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Cologne, Germany
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Essen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Mainz, Germany
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München, Germany
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Tübingen, Germany
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Ulm, Germany
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Hong Kong, Hong Kong
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Bangalore, India
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Bhubneshwar, India
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Chennai, India
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Hubli, India
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Hyderabad, India
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Karmsad, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Benevento, Italy
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Meldola, Italy
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Milan, Italy
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Naples, Italy
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Perugia, Italy
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Pisa, Italy
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Roma, Italy
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Rozzano, Italy
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Bunkyoku, Japan
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Chiba, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Iizuka, Japan

Showing the first 100 of 160 sites across 17 countries.

References and documents

Publications

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 ↗

Study documents

Study protocol · Jun 17, 2024
Statistical analysis plan · Jul 30, 2021

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03298451
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Oct 2, 2017
Start date: Oct 11, 2017
Primary completion: Aug 27, 2021
Completion: Dec 31, 2027 (estimated)
Results posted: Jun 18, 2023
Last update: Jul 27, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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