TriangleNCT03875235 · STUDY IN CONTEXT
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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).
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).
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).
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- trial label
- Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0000
- source section id
- NCT03875235-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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).
- time origin
- 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)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0001
- source section id
- NCT03875235-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) Rate at 18 Months
- endpoint definition
- 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).
- time origin
- From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0002
- source section id
- NCT03875235-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS) Rate at 24 Months
- endpoint definition
- 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).
- time origin
- From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0003
- source section id
- NCT03875235-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0004
- source section id
- NCT03875235-om-0004
- source outcome index
- 4
- endpoint
- Progression-free Survival (PFS) Rate at 9 Months
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0005
- source section id
- NCT03875235-om-0005
- source outcome index
- 5
- endpoint
- Progression-free Survival (PFS) Rate at 12 Months
- endpoint definition
- 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.
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Durvalumab + Gemcitabine + Cisplatin
- regimen
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 341
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo + Gemcitabine + Cisplatin
- regimen
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 344
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Durvalumab + Gemcitabine + Cisplatin
- regimen
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 341
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo + Gemcitabine + Cisplatin
- regimen
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 344
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Durvalumab + Gemcitabine + Cisplatin
- regimen
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 341
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo + Gemcitabine + Cisplatin
- regimen
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 344
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Durvalumab + Gemcitabine + Cisplatin
- regimen
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 341
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo + Gemcitabine + Cisplatin
- regimen
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 344
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Durvalumab + Gemcitabine + Cisplatin
- regimen
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 341
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo + Gemcitabine + Cisplatin
- regimen
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 344
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Durvalumab + Gemcitabine + Cisplatin
- regimen
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 341
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo + Gemcitabine + Cisplatin
- regimen
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- analyzed count
- 344
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03875235-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- harm key
- EG000
- source section id
- NCT03875235-ae
- event group key
- EG000
- event group label
- Durvalumab + Gemcitabine + Cisplatin
- serious affected
- 168
- serious at risk
- 338
- other affected
- 326
- other at risk
- 338
- frequency threshold
- 5
- collection period
- Adverse events: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.
- event definition
- There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-biliary-tract-neoplasm
- nct id
- NCT03875235
- harm key
- EG001
- source section id
- NCT03875235-ae
- event group key
- EG001
- event group label
- Placebo + Gemcitabine + Cisplatin
- serious affected
- 152
- serious at risk
- 342
- other affected
- 330
- other at risk
- 342
- frequency threshold
- 5
- collection period
- Adverse events: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.
- event definition
- There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice