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

NCT03046862 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-04-19

No results posted yet for this study

Summary

\<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.

Conditions

  • Biliary Tract Neoplasms

Interventions

DRUG

Durvalumab

Durvalumab 1.12 g iv on D1 every 3 weeks

DRUG

Tremelimumab

Tremelimumab 75mg iv on D1 every 3 weeks

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 iv on D1\& D8 every 3 weeks

DRUG

Cisplatin

Cisplatin 25 mg/m2 iv on D1\& D8 every 3 weeks

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Do-Youn Oh, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-25
Primary Completion
2020-05-30
Completion
2024-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03046862 on ClinicalTrials.gov