Study of Pembrolizumab and Olaparib in Bile Duct Cancer
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|ClinicalTrials.gov Identifier: NCT04306367|
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: Pembrolizumab Drug: Olaparib||Phase 2|
The primary objective of the study is to assess the ORR of patients with advanced cholangiocarcinoma receiving a combination of pembrolizumab and olaparib. It is hypothesized that the addition of olaparib will improve the response rate of second line systemic therapy from 17.5% to 35% in patients with advanced cholangiocarcinoma.
The study is designed to enroll 33 subjects (for 85% power) with advanced stage cholangiocarcinoma to test the hypothesis that the combination of olaparib and pembrolizumab will increase the ORR in comparison with the ORR from second line systemic chemotherapy (historical control) in this patient population. As the primary study endpoint, which is also being used to determine the sample size of the study, the investigators propose that the combination of olaparib and pembrolizumab will increase the ORR to 35% from 17.5% (achieved with systemic cytotoxic chemotherapy including mFOLFOX-historical control). To allow a 10% patient drop off rate, the investigators expect to enroll a total of 36 subjects into this study. In addition, as secondary study endpoints the investigators expect to see an increase in the PFS and OS of patients receiving combination therapy compared to cytotoxic chemotherapy.
In this study, the investigators propose the collection of three biopsies-one at baseline prior to the start of treatment, one at the beginning of week 4, three weeks after the administration of combination olaparib and pembrolizumab, and one at the time of cancer progression-for the elucidation of exploratory study endpoints. Patients will have a CT or MRI scan at the beginning of treatment and then every 6 weeks thereafter for the first six months of study treatment administration, then every 9 weeks for up to 12 months after the start of treatment, followed by every 12 weeks up to 24 months on study. All patients will continue to receive olaparib and pembrolizumab combination treatment as tolerated unless unacceptable toxicities or cancer progression occur, at which time therapy will cease. In the absence of any problems, the planned study duration is 20-36 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-arm Study of Combination Pembrolizumab and Olaparib in the Treatment of Patients With Advanced Cholangiocarcinoma|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2022|
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
- efficacy in terms of response rate [ Time Frame: 6 months ]percent of patients respond to the treatment
- efficacy in terms of duration of response [ Time Frame: 9 months ]the duration of response (DOR) of patient, taking best overall response to progression.
- efficacy interms of progression free survival [ Time Frame: 24 weeks ]progression free survival (PFS) of patients taking best overall response to progression or death from any cause, whichever occurs first.
- efficacy in terms of overall survival [ Time Frame: 40 weeks ]overall survival (OS) of patients from baseline to date of death or last follow up.
- Safety and tolerability [ Time Frame: 1 year ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306367
|United States, District of Columbia|
|Lombardi Cancer Center at Georgetown University||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Violeta Milic 202-687-2353 firstname.lastname@example.org|
|Principal Investigator: Aiwu Ruth He, MD|