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 2026-10-07.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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Among 42 studies testing durvalumab in Carcinoma, Hepatocellular — 22 open to participants now, 32 under way, 4 of them phase 3. durvalumab · Carcinoma, Hepatocellular.
Among the 42 studies testing durvalumab in Carcinoma, Hepatocellular, this one has the largest enrollment, is the only one that started in 2017, is one of 5 in phase 3, reaches primary completion later than 1 of the 31 other live ones, and was the 4th registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →22 of the 42 studies testing durvalumab in Carcinoma, Hepatocellular are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Australia, Georgia, Poland and 2 more countries
Ages 18+
Center Eugene Marquis · Sites in France
Ages 18+
Emory University · Sites in United States
Ages 18+
Hamilton Health Sciences Corporation · Sites in Canada
Ages 18+
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
durvalumab: first FDA approval 2017 (IMFINZI), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, durvalumab is the treatment under test here. Read study by study →
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 31 · Phase 3 5
First in 2015; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,324 is above the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 37 across the 42 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 42 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
25 studies in Carcinoma, Hepatocellular by AstraZeneca: 7 open now, 16 under way, 5 of them phase 3. Of 8 finished, 2 (25%) have results posted.
Among the 25 studies in Carcinoma, Hepatocellular by AstraZeneca, this one has the largest enrollment of the 17 interventional ones that give a count, is the only one that started in 2017, is one of 6 in phase 3, reaches primary completion later than 1 of the 15 other live ones, and was the 6th registered.
AstraZeneca’s Carcinoma, Hepatocellular studies by the year they started, since 2009.
9 of the studies testing durvalumab in Carcinoma, Hepatocellular that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07027436Phase 3Hamilton Health Sciences CorporationRadiation Therapy Followed by Durvalumab (MEDI4736) and Tremelimumab And Surgery Versus Radiation Therapy Followed by Surgery for Resectable Hepatocellular Carcinoma. | 2027-10-12 |
| NCT07081633AstraZenecaDurvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma | 2026-11-30 |
| NCT05844046Enrico De ToniSequential or Up-front Triple Treatment With Durvalumab, Tremelimumab and Bevacizumab for Non-resectable Hepatocellular Carcinoma (HCC) Patients | 2026-12-31 |
| NCT05063565Boston Scientific CorporationTheraSphere With Durvalumab and Tremelimumab for HCC | 2027-06 |
| NCT06470256Zhiyong HuangPalliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma | 2027-06-01 |
Add all 9 to your calendar (.ics) → With an account.
Among the 42 studies testing durvalumab in Carcinoma, Hepatocellular, from their registry updates:
Among AstraZeneca’s 25 in Carcinoma, Hepatocellular:
This tab as a report to print or save as PDF → With an account.
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
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Durvalumab
Drug: Durvalumab
Durvalumab in combination with tremelimumab (Regimen 1)
Drug: Tremelimumab (Regimen 1) · Drug: Durvalumab (Regimen 1)
Durvalumab in combination with tremelimumab (Regimen 2)
Drug: Tremelimumab (Regimen 2) · Drug: Durvalumab (Regimen 2)
Sorafenib
Drug: Sorafenib
Durvalumab IV (intravenous infusion).
Also known as: MEDI4736
Tremelimumab IV (intravenous infusion).
Tremelimumab IV (intravenous infusion).
Sorafenib, as per standard of care
Durvalumab IV (intravenous infusion).
Durvalumab IV (intravenous infusion).
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).
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).
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).
| 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 |
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).
| 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) |
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).
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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 |
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.
| 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 |
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.
| 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) |
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%).
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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 | — |
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.
| 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 | — |
Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported 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 | — |
Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported 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 | — |
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.
| 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%) |
| 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 |
| 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 |
The full analysis set (FAS) included all participants who were randomized.
| 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(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(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(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(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(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 |
Showing the first 100 of 160 sites across 17 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Aug 2021, 46 months.
Results were first posted in Jun 2023, 1 year 9 months after primary completion.
Of 52 industry-sponsored phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 63. This study's 46 months is below that.
Counting every sponsor, half of 138 studies reached it within 56 months; a quarter within 43 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Durvalumab · Tremelimumab