Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT03046862
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1.12 g iv on D1 every 3 weeks
  • Tremelimumab — DRUG
    Tremelimumab 75mg iv on D1 every 3 weeks
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 iv on D1\& D8 every 3 weeks
  • Cisplatin — DRUG
    Cisplatin 25 mg/m2 iv on D1\& D8 every 3 weeks

Study Details

\<Research Hypothesis\> The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered. The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer. \<Purpose of the study\> To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients.

Key Dates

Start date
Feb 25, 2017
Status verified
Apr 2024
Primary completion
May 30, 2020
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Durvalumab/Tremelimumab+chemotherapy
    Durvalumab and Tremelimumab in combination with gemcitabine/cisplatin.

Primary Outcome Measure

Response rate [ Time Frame: 6 weeks ]

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