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d933ac00001-study-synopsis-redact.pdf

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

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

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.

Research Site

Durvalumab in Combination with Gemcitabine plus Cisplatin
Placebo in Combination with Gemcitabine plus Cisplatin

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Age Continuous

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Baseline analysis was based on all patients in the full analysis set (FAS), which comprised all patients randomized prior to or on 18 December 2020. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.

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).

The 2-sided significance level for OS at the second interim analysis was 3%.

Overall Survival (OS)

Overall Survival (OS) rate at 18 months

Overall Survival (OS) rate at 24 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.

The 2-sided significance level for PFS at the second interim analysis was 4.81%.

Progression-free survival (PFS)

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.

Progression-free survival (PFS) rate at 9 months

Progression-free survival (PFS) rate at 12 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.

Full analysis set - subjects with measurable disease at baseline

Objective Response Rate (ORR)

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.

Full analysis set - subjects with objective response and measurable disease at baseline

Duration of Response (DoR)

Duration of Response (DoR): percentage remaining in response at 9 months

Duration of Response (DoR): percentage remaining in response at 12 months

Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).

Disease Control Rate (DCR) - Overall

Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 24 or who have stable disease (SD) at least 24 weeks following start of treatment.

Disease Control Rate (DCR) - 24 weeks

Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 32 or who have stable disease (SD) at least 32 weeks following start of treatment.

Disease Control Rate (DCR) - 32 weeks

Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 48 or who have stable disease (SD) at least 48 weeks following start of treatment.

Disease Control Rate (DCR) - 48 weeks

Overall Study

Eligible patients previously untreated for unresectable locally advanced or metastatic Biliary Tract Cancer (BTC) were randomized in a 1:1 ratio with either Durvalumab in combination with Gemcitabine/Cisplatin or Placebo in combination with Gemcitabine/Cisplatin. Randomization was stratified by disease status (initially unresectable versus recurrent) and primary tumor site (IHCC versus EHCC versus GBC).

Arms	Assigned Interventions
Experimental: Treatment Arm Durvalumab + Gemcitabine + Cisplatin	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.
Placebo Comparator: Placebo Arm Placebo + Gemcitabine + Cisplatin	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.

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

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Trial Results Summaries

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Documents available

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D933AC00001&amp;attachmentIdentifier=f0f0274f-a72a-4d83-8200-e6a74d44d8fe&amp;fileName=D933AC00001_-___Statistical_Analysis_Plan-redact.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D933AC00001&amp;attachmentIdentifier=88a80119-302b-4810-bce2-623ab0a77f31&amp;fileName=d933ac00001-oncology-late-phase-master-csp-v8-redact.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D933AC00001&amp;attachmentIdentifier=7f0ef0d5-6fe8-4acc-8de5-143b4c68c4d9&amp;fileName=d933ac00001-study-synopsis-redact.pdf&amp;versionIdentifier=

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=f0f0274f-a72a-4d83-8200-e6a74d44d8fe&fileName=D933AC00001_-___Statistical_Analysis_Plan-redact.pdf&versionIdentifier=

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