Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05771480
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Participants will receive 1500 mg every 3 weeks, or every 4 weeks (in combination with chemotherapy every 3 weeks, or every 2 weeks, respectively) from cycle 1 to cycle 8 of chemotherapy. Upon completion, participants will receive 1500 mg every 4 weeks (as monotherapy)
  • Gemcitabine monotherapy — DRUG
    Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
  • Gemcitabine + cisplatin — DRUG
    Gemcitabine plus cisplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) for WHO/ECOG PS 2 participants only
  • Gemcitabine + oxaliplatin — DRUG
    Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
  • Gemcitabine + carboplatin — DRUG
    Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
  • Gemcitabine + cisplatin + S-1 — DRUG
    Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks (i.e, 4 cycles of durvalumab)
  • Gemcitabine + S-1 — DRUG
    Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
  • Gemcitabine + cisplatin + albumin-bound paclitaxel — DRUG
    Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

Study Details

A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.

Key Dates

Start date
Aug 16, 2023
Status verified
Apr 2026
Primary completion
Oct 2, 2025
Completion
Sep 17, 2026

Study Design

Enrollment
142 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Gemcitabine based chemotherapy
    Participants will receive durvalumab 1500mg every 3 or 4 weeks, in combination with continuation of all or some of the original background gemcitabine based chemotherapy every 3 or 2 weeks for up to a maximum of 8 cycles of chemotherapy. Durvalumab 1500mg is given as a 60-minute IV infusion in the first cycle (Day 1) and as a 30-minute IV infusion in following cycles. Upon completing 8 cycles of background gemcitabine-chemotherapy, or after discontinuing any of the combination chemotherapies due to toxicity before completing 8 cycles, participants are eligible to continue receiving durvalumab 1500 mg IV every 4 weeks either alone or in combination with gemcitabine-based chemotherapy (with the exception of paclitaxel), as per investigator's discretion.

Primary Outcome Measure

Number of participants with Grade 3 or 4 possibly related adverse event (PRAE) [ Time Frame: Within 6 months after the initiation of Investigational Medicinal Product (IMP) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteMobileAlabama36607-
Research SiteOrangeCalifornia92868-
Research SiteWashington D.C.District of Columbia20007-
Research SitePortlandOregon97213-

Find similar trials in Mobile, AL

By research site
Research Site· Mobile, ALResearch Site· Orange, CAResearch Site· Washington D.C., DCResearch Site· Portland, OR

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