Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT04034927|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Carcinosarcoma Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Fallopian Tube Undifferentiated Carcinoma Germline BRCA1 Gene Mutation Germline BRCA2 Gene Mutation High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Ovarian Clear Cell Tumor Ovarian Seromucinous Carcinoma Ovarian Undifferentiated Carcinoma Platinum-Sensitive Fallopian Tube Carcinoma Platinum-Sensitive Ovarian Carcinoma Platinum-Sensitive Primary Peritoneal Carcinoma Primary Peritoneal Carcinosarcoma Primary Peritoneal Clear Cell Carcinoma Primary Peritoneal High Grade Serous Adenocarcinoma Primary Peritoneal Transitional Cell Carcinoma Primary Peritoneal Undifferentiated Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Endometrioid Adenocarcinoma Recurrent Ovarian Serous Adenocarcinoma Recurrent Ovarian Transitional Cell Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Olaparib Biological: Tremelimumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer|
|Estimated Study Start Date :||October 12, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Arm I (olaparib)
Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (olaparib, tremelimumab)
Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity.
- Progression free survival (PFS) [ Time Frame: Duration of time from study entry to time of progression per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death due to any cause, whichever occurs first, assessed up to 5 years ]
- Dose-limiting toxicity (DLT) (Safety Lead-In) [ Time Frame: Up to 4 weeks ]Descriptive statistics will be used to summarize adverse events (AEs). The primary summary of AEs will present counts and percentages, regardless of whether the AE was attributed to any of the study agents.
- RECIST 1.1 response (Efficacy Lead-In) [ Time Frame: Up to 5 years ]A logistic model will be used to estimate the relative odds of responding (CR+PR) to olaparib + tremelimumab relative to olaparib after adjusting for BRCA mutation status and prior PARP inhibitor (PARPi) usage.
- Objective response [ Time Frame: Up to 5 years ]The objective response rate is the percentage of subjects with a best overall complete response (CR) or partial response (PR) among those with target lesions at the time of enrollment.
- Overall survival (OS) [ Time Frame: Time from enrollment and randomization to the date of death due to any cause, assessed up to 5 years ]Kaplan-Meier procedures will be used to estimate the cumulative distribution of survival times for each treatment in this population. A proportional hazards model stratified by BRCA status and prior PARPi treatment will be used to estimate the treatment hazard ratio and the corresponding confidence interval.
- Incidence of adverse events [ Time Frame: Up to 5 years ]Safety data will be summarized for all treated subjects. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
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): NCT04034927
|Principal Investigator:||Sarah F Adams||NRG Oncology|