Study of Pembrolizumab and Olaparib in Bile Duct Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT04306367
Phase
PHASE2
Status
Completed

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    200 mg given intravenously.
  • Olaparib — DRUG
    300 mg given orally.

Study Details

The investigators propose an open label, one-arm study to assess the safety and efficacy of olaparib and pembrolizumab in patients with cholangiocarcinoma who have progressed on or cannot tolerate gemcitabine-based therapy.

Key Dates

Start date
Apr 1, 2020
Status verified
Feb 2025
Primary completion
Jul 16, 2023
Completion
Dec 19, 2024

Study Design

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

Arms

  • Experimental: Experimental
    Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle) Olaparib bid, Oral tablet continuously

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007-

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Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DC

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