Trial · NCT03298451
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT03298451, Phase 3, Active not recruiting, AstraZeneca; results first posted 2023-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma. Trials, record NCT03298451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03298451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- NCT number
- NCT03298451
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,324 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Durvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1), Durvalumab (Regimen 2)
- First posted
- 2017-10-02
- Last updated
- 2026-10-07
- Other registries' IDs
- eudract:2016-005126-11
- Results first posted
- 2023-06-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). | 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). |
| Secondary | Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg | From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). | 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). |
| Secondary | Overall Survival (OS) at 18, 24, and 36 Months After Randomization | At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021). | 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. |
| Secondary | Progression Free Survival (PFS) | 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) | 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. |
| Secondary | Time To Progression (TTP) | From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). | 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. |
| Secondary | Objective Response Rate (ORR) | From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). | 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. |
| Secondary | Disease Control Rate (DCR) | 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). | 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. |
| Secondary | Duration of Objective Response (DoR) | 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). | 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. |
| Secondary | Overall Survival (OS) by PD-L1 | 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). | 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%). |
| Secondary | EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration | 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. | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). | The FAS included all participants who were randomized. T75+D arm was closed during study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg | From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). | The FAS included all participants who were randomized. T75+D arm was closed during study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) at 18, 24, and 36 Months After Randomization | At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021). | The FAS included all participants who were randomized. T75+D arm was closed during study. | percentage of survival | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | 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) | The FAS included all participants who were randomized. T75+D arm was closed during study. | months | MEDIAN |
| SECONDARY | Time To Progression (TTP) | From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). | The FAS included all participants who were randomized. T75+D arm was closed during study. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). | The FAS included all participants who were randomized. T75+D arm was closed during study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | 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). | The FAS included all participants who were randomized. T75+D arm was closed during study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Objective Response (DoR) | 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). | A subset of FAS subjects who achieve confirmed CR or PR as determined per RECIST 1.1 using Investigator assessment. T75+D arm was closed during study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) by PD-L1 | 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). | A subset of FAS who had non-missing baseline PD-L1 status. T75+D arm was closed during study. | months | MEDIAN |
| SECONDARY | EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration | 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. | A subset of the FAS who had baseline scores of \>=10. T75+D arm was closed during study. | months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | Durva 1500 mg | 16.56 | 95% Confidence Interval 14.06 to 19.12 | months | |
| Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | Treme 300 mg x1 Dose + Durva 1500 mg | 16.43 | 95% Confidence Interval 14.16 to 19.58 | months | |
| Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | Treme 75 mg x4 Doses + Durva 1500 mg | 16.36 | 95% Confidence Interval 12.39 to 19.65 | months | |
| Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | Sora 400 mg | 13.77 | 95% Confidence Interval 12.25 to 16.13 | months | |
| Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg | Durva 1500 mg | 16.56 | 95% Confidence Interval 14.06 to 19.12 | months | |
| Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg | Treme 300 mg x1 Dose + Durva 1500 mg | 16.43 | 95% Confidence Interval 14.16 to 19.58 | months | |
| Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg | Treme 75 mg x4 Doses + Durva 1500 mg | 16.36 | 95% Confidence Interval 12.39 to 19.65 | months | |
| Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg | Sora 400 mg | 13.77 | 95% Confidence Interval 12.25 to 16.13 | months | |
| Overall Survival (OS) at 18, 24, and 36 Months After Randomization | Durva 1500 mg | Survival rate at 18 months | 47.4 | 95% Confidence Interval 42.4 to 52.3 | percentage of survival |
| Overall Survival (OS) at 18, 24, and 36 Months After Randomization | Treme 300 mg x1 Dose + Durva 1500 mg | Survival rate at 18 months | 48.7 | 95% Confidence Interval 43.6 to 53.5 | percentage of survival |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durva 1500 mg | 389 | |
| Overall Study | STARTED | Treme 300 mg x1 Dose + Durva 1500 mg | 393 | |
| Overall Study | STARTED | Treme 75 mg x4 Doses + Durva 1500 mg | 153 | |
| Overall Study | STARTED | Sora 400 mg | 389 | |
| Overall Study | Received Treatment | Durva 1500 mg | 386 | |
| Overall Study | Received Treatment | Treme 300 mg x1 Dose + Durva 1500 mg | 389 | |
| Overall Study | Received Treatment | Treme 75 mg x4 Doses + Durva 1500 mg | 153 | |
| Overall Study | Received Treatment | Sora 400 mg | 374 | |
| Overall Study | COMPLETED | Durva 1500 mg | 104 | |
| Overall Study | COMPLETED | Treme 300 mg x1 Dose + Durva 1500 mg | 125 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,308
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Durva 1500 mg | 42 | 388 | 49 |
| other | Alanine aminotransferase increased | Investigations | Treme 300 mg x1 Dose + Durva 1500 mg | 35 | 388 | 45 |
| other | Alanine aminotransferase increased | Investigations | Treme 75 mg x4 Doses + Durva 1500 mg | 9 | 152 | 9 |
| other | Alanine aminotransferase increased | Investigations | Sora 400 mg | 20 | 374 | 26 |
| other | Amylase increased | Investigations | Durva 1500 mg | 9 | 388 | 11 |
| other | Amylase increased | Investigations | Treme 300 mg x1 Dose + Durva 1500 mg | 28 | 388 | 38 |
| other | Amylase increased | Investigations | Treme 75 mg x4 Doses + Durva 1500 mg | 6 | 152 | 6 |
| other | Amylase increased | Investigations | Sora 400 mg | 10 | 374 | 17 |
| other | Aspartate aminotransferase increased | Investigations | Durva 1500 mg | 54 | 388 | 63 |
| other | Aspartate aminotransferase increased | Investigations | Treme 300 mg x1 Dose + Durva 1500 mg | 46 | 388 | 53 |
1 to 10 of 1,308Source ClinicalTrials.gov
See all 1,308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durva 1500 mg | 280 | 389 |
| Total, all-cause mortality | Treme 300 mg x1 Dose + Durva 1500 mg | 262 | 393 |
| Total, all-cause mortality | Treme 75 mg x4 Doses + Durva 1500 mg | 123 | 153 |
| Total, all-cause mortality | Sora 400 mg | 293 | 389 |
| Total, other adverse events | Durva 1500 mg | 299 | 388 |
| Total, other adverse events | Treme 300 mg x1 Dose + Durva 1500 mg | 334 | 388 |
| Total, other adverse events | Treme 75 mg x4 Doses + Durva 1500 mg | 133 | 152 |
| Total, other adverse events | Sora 400 mg | 333 | 374 |
| Total, serious adverse events | Durva 1500 mg | 115 | 388 |
| Total, serious adverse events | Treme 300 mg x1 Dose + Durva 1500 mg | 157 | 388 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03298451
GET https://conductscience.org/api/trials/v1/NCT03298451/results?page=2