Trial · NCT03875235

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

NCT03875235, Phase 3, Active not recruiting, AstraZeneca; results first posted 2023-04-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1). Trials, record NCT03875235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03875235

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
NCT number: NCT03875235
Status: Active not recruiting
Phases: Phase 3
Enrollment: 810 participants, actual
Lead sponsor: AstraZeneca
Conditions: Biliary Tract Neoplasms
Interventions: Durvalumab, Placebo
First posted: 2019-03-14
Last updated: 2026-08-26
Other registries' IDs: eudract:2018-004688-30
Results first posted: 2023-04-13

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)	Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Primary	Overall Survival (OS) Rate at 18 Months	From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.	Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Primary	Overall Survival (OS) Rate at 24 Months	From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.	Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Secondary	Progression-free Survival (PFS)	Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.	PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Secondary	Progression-free Survival (PFS) Rate at 9 Months	Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 9 months using the Kaplan-Meier technique.	PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Secondary	Progression-free Survival (PFS) Rate at 12 Months	Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 12 months using the Kaplan-Meier technique	PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Secondary	Objective Response Rate (ORR)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.	Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Secondary	Duration of Response (DoR)	Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.	The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Secondary	Duration of Response (DoR): Percentage Remaining in Response at 9 Months	Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 9 months using the Kaplan-Meier technique	The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Secondary	Duration of Response (DoR): Percentage Remaining in Response at 12 Months	Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 12 months using the Kaplan-Meier technique	The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)	Full analysis set	Months	MEDIAN
PRIMARY	Overall Survival (OS) Rate at 18 Months	From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.	Full analysis set	Percentage of Participants	NUMBER
PRIMARY	Overall Survival (OS) Rate at 24 Months	From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.	Full analysis set	Percentage of Participants	NUMBER
SECONDARY	Progression-free Survival (PFS)	Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.	Full analysis set	Months	MEDIAN
SECONDARY	Progression-free Survival (PFS) Rate at 9 Months	Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 9 months using the Kaplan-Meier technique.	Full analysis set	Percentage of Participants	NUMBER
SECONDARY	Progression-free Survival (PFS) Rate at 12 Months	Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 12 months using the Kaplan-Meier technique	Full analysis set	Percentage of Participants	NUMBER
SECONDARY	Objective Response Rate (ORR)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.	Full analysis set - subjects with measurable disease at baseline	Percentage of Participants	NUMBER
SECONDARY	Duration of Response (DoR)	Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.	Full analysis set - subjects with objective response and measurable disease at baseline	Months	MEDIAN
SECONDARY	Duration of Response (DoR): Percentage Remaining in Response at 9 Months	Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 9 months using the Kaplan-Meier technique	Full analysis set - subjects with objective response and measurable disease at baseline	Percentage of Participants	NUMBER
SECONDARY	Duration of Response (DoR): Percentage Remaining in Response at 12 Months	Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 12 months using the Kaplan-Meier technique	Full analysis set - subjects with objective response and measurable disease at baseline	Percentage of Participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Durvalumab + Gemcitabine + Cisplatin	12.8	95% Confidence Interval 11.1 to 14.0	Months
Overall Survival (OS)	Placebo + Gemcitabine + Cisplatin	11.5	95% Confidence Interval 10.1 to 12.5	Months
Overall Survival (OS) Rate at 18 Months	Durvalumab + Gemcitabine + Cisplatin	35.1	95% Confidence Interval 29.1 to 41.2	Percentage of Participants
Overall Survival (OS) Rate at 18 Months	Placebo + Gemcitabine + Cisplatin	25.6	95% Confidence Interval 19.9 to 31.7	Percentage of Participants
Overall Survival (OS) Rate at 24 Months	Durvalumab + Gemcitabine + Cisplatin	24.9	95% Confidence Interval 17.9 to 32.5	Percentage of Participants
Overall Survival (OS) Rate at 24 Months	Placebo + Gemcitabine + Cisplatin	10.4	95% Confidence Interval 4.7 to 18.8	Percentage of Participants
Progression-free Survival (PFS)	Durvalumab + Gemcitabine + Cisplatin	7.2	95% Confidence Interval 6.7 to 7.4	Months
Progression-free Survival (PFS)	Placebo + Gemcitabine + Cisplatin	5.7	95% Confidence Interval 5.6 to 6.7	Months
Progression-free Survival (PFS) Rate at 9 Months	Durvalumab + Gemcitabine + Cisplatin	34.8	95% Confidence Interval 29.6 to 40.0	Percentage of Participants
Progression-free Survival (PFS) Rate at 9 Months	Placebo + Gemcitabine + Cisplatin	24.6	95% Confidence Interval 20.0 to 29.5	Percentage of Participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Durvalumab + Gemcitabine + Cisplatin	341
Overall Study	STARTED	Placebo + Gemcitabine + Cisplatin	344
Overall Study	Treated	Durvalumab + Gemcitabine + Cisplatin	338
Overall Study	Treated	Placebo + Gemcitabine + Cisplatin	342
Overall Study	COMPLETED	Durvalumab + Gemcitabine + Cisplatin	0
Overall Study	COMPLETED	Placebo + Gemcitabine + Cisplatin	0
Overall Study	NOT COMPLETED	Durvalumab + Gemcitabine + Cisplatin	341
Overall Study	NOT COMPLETED	Placebo + Gemcitabine + Cisplatin	344

Source ClinicalTrials.gov

Adverse events484

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	Urinary tract infection	Infections and infestations	Durvalumab + Gemcitabine + Cisplatin	21	338	29
other	Urinary tract infection	Infections and infestations	Placebo + Gemcitabine + Cisplatin	20	342	22
other	Alanine aminotransferase increased	Investigations	Durvalumab + Gemcitabine + Cisplatin	31	338	41
other	Alanine aminotransferase increased	Investigations	Placebo + Gemcitabine + Cisplatin	34	342	44
other	Aspartate aminotransferase increased	Investigations	Durvalumab + Gemcitabine + Cisplatin	25	338	35
other	Aspartate aminotransferase increased	Investigations	Placebo + Gemcitabine + Cisplatin	31	342	39
other	Blood bilirubin increased	Investigations	Durvalumab + Gemcitabine + Cisplatin	11	338	12
other	Blood bilirubin increased	Investigations	Placebo + Gemcitabine + Cisplatin	20	342	22
other	Blood creatinine increased	Investigations	Durvalumab + Gemcitabine + Cisplatin	10	338	12
other	Blood creatinine increased	Investigations	Placebo + Gemcitabine + Cisplatin	33	342	43

1 to 10 of 484Source ClinicalTrials.gov

See all 484 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Durvalumab + Gemcitabine + Cisplatin	308	341
Total, all-cause mortality	Placebo + Gemcitabine + Cisplatin	326	344
Total, other adverse events	Durvalumab + Gemcitabine + Cisplatin	326	338
Total, other adverse events	Placebo + Gemcitabine + Cisplatin	330	342
Total, serious adverse events	Durvalumab + Gemcitabine + Cisplatin	168	338
Total, serious adverse events	Placebo + Gemcitabine + Cisplatin	152	342

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38319896	DERIVED	PubMed
38661512	DERIVED	PubMed
38697156	DERIVED	PubMed
38823398	DERIVED	PubMed
40381735	DERIVED	PubMed
40622010	DERIVED	PubMed
42424063	DERIVED	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Durvalumab + Gemcitabine + Cisplatin vs Placebo + Gemcitabine + Cisplatin: deaths from any cause	Trial comparisons
Durvalumab + Gemcitabine + Cisplatin vs Placebo + Gemcitabine + Cisplatin: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03875235

GET https://conductscience.org/api/trials/v1/NCT03875235/results?page=2

API reference For AI assistants