Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer (OLAPem)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04417192|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Olaparib Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study has 2 cohorts. Cohort 1 is Olaparib monotherapy Cohort 2 is Olaparib plus Pembrolizumab combination therapy|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate the Efficacy and Safety of Preoperative Olaparib Monotherapy and Preoperative Olaparib Plus Pembrolizumab Combination Therapy in Patients With HRD-Positive Stage III or IV Advanced Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Olaparib or Olaparib Plus Pembrolizumab
Cohort 1 : Olaparib will be administered for 6 weeks before surgery. Cohort 2 : Olaparib and Pembrolizumab will be administered simultaneously for 2 cycles(6 weeks) before surgery.
Olaparib will be administered at a dose of 300mg as oral dose, twice a day.
Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
- Objective response rate (ORR) [ Time Frame: 6 weeks ]Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1.
- The incidence of adverse events [ Time Frame: Up to 30 days after the last dose ]The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Chemotherapy response score (CRS) [ Time Frame: 6 months from the end of registration ]To evaluate the effect of histopathological treatment on patients with serous carcinoma and metastasis to the omentum. The histopathological treatment effect is determined according to the chemotherapy response score (CRS)
- Progression-free survival (PFS) [ Time Frame: 6 months from the end of registration ]PFS is defined as the time from the first dose to the earlier of progression assessed by the Investigator per RECIST v. 1.1 (PD) or clinical criteria, or death due to any cause.
- Overall survival (OS) [ Time Frame: 6 months from the end of registration ]OS is defined as the time from the first dose to death due to any cause.
- Biomarkers [ Time Frame: 2 years ]Relationship between the germline mutation and therapeutic effect
- The change in tumor-infiltrating lymphocytes [ Time Frame: 2 years ]Relationship between the change in tumor-infiltrating lymphocytes in tumor tissue before and after therapy, and the therapeutic effect
- The therapeutic effect [ Time Frame: 2 years ]Relationship between the Tumor Mutation Burden (TMB) and the therapeutic effect
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): NCT04417192
|Contact: Kenichi Harano, MD||+81-4-7133-1111||OLAPem_core@east.ncc.go.jp|
|National Cancer Center Hospital East|
|Kashiwa, Chiba, Japan|
|Contact: Kenichi Harano, MD +81-4-7133-1111 OLAPem_core@east.ncc.go.jp|
|National Hospital Organization Shikoku Cancer Center|
|Matsuyama, Ehime, Japan|
|Contact: Kazuhiro Takehara, MD|
|Kurume University Hospital|
|Kurume, Fukuoka, Japan|
|Contact: Shin Nishio, MD|