Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04034927|
Recruitment Status : Suspended (Scheduled Interim Monitoring)
First Posted : July 29, 2019
Last Update Posted : December 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Endometrioid Tumor High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Malignant Ovarian Endometrioid Tumor Platinum-Sensitive Fallopian Tube Carcinoma Platinum-Sensitive Ovarian Carcinoma Platinum-Sensitive Primary Peritoneal Carcinoma Primary Peritoneal High Grade Serous Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Fallopian Tube Endometrioid Adenocarcinoma Recurrent Ovarian Endometrioid Adenocarcinoma Recurrent Ovarian Serous Adenocarcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Primary Peritoneal Endometrioid Adenocarcinoma||Drug: Olaparib Biological: Tremelimumab||Phase 2|
|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|
|Actual Study Start Date :||October 11, 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|