Clinical Trials /

Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer

NCT04361370

Description:

This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.

Related Conditions:
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Low Grade Fallopian Tube Serous Adenocarcinoma
  • Low Grade Ovarian Serous Adenocarcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal Clear Cell Carcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer
  • Official Title: A Single-arm Phase II Study of Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer (OPEB-01)

Clinical Trial IDs

  • ORG STUDY ID: 2020-0602-001
  • NCT ID: NCT04361370

Conditions

  • Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer

Interventions

DrugSynonymsArms
Olaparib-Pembrolizumab-BevacizumabTreatment group

Purpose

This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.

Detailed Description

      'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy
      and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with
      platinum-sensitive who have received prior of platinum-based chemotherapy. The study will
      assess the effectiveness of progression-free survival(6 months PFS rate) as determined by
      Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated to
      until disease progression as below:

        -  Maintenance : Olaparib 300mg (twice daily [BID])

        -  Pembrolizumab 200mg every 3 weeks (Q3W) for up to 35 infusions

        -  Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)
    

Trial Arms

NameTypeDescriptionInterventions
Treatment groupExperimentalBRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer
  • Olaparib-Pembrolizumab-Bevacizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Participant has histologically confirmed diagnosis of high-grade predominantly serous,
             endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear
             cell, or low-grade serous OC, primary peritoneal cancer, or fallopian tube cancer will
             be enrolled in this study (only up to 8 patients with clear cell carcinoma will be
             included and mucinous carcinoma will not be included).

          -  Participant has received 2 previous courses of platinum-containing therapy, and has
             disease that was considered platinum sensitive following the penultimate (next to
             last) platinum course (more than 6 months' period between penultimate platinum regimen
             and progression of disease

          -  Participant has responded to last the platinum regimen (complete or partial response),
             remains in response and is enrolled on study within 8 weeks of completion of the last
             platinum regimen

          -  Participant is able to provide a newly obtained core or excisional biopsy of a tumor
             lesion for prospective testing of BRCA 1/2 and PD-L1 status prior to enrollment

          -  Female participants who are at least 20 years of age and Eastern Cooperative Oncology
             Group (ECOG) performance status of 0 or 1

          -  Participant has adequate organ function as defined in the following:

               1. ANC≥1500/µL

               2. PLT≥100 000/µL

               3. Hemoglobin≥9.0 g/dL or ≥5.6 mmol/L

               4. Creatinine≤1.5 × ULN or calculated creatinine clearance≥30 mL/min for participant
                  with creatinine levels >1.5 × institutional ULN

               5. Total bilirubin≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total
                  bilirubin levels >1.5 × ULN

               6. AST (SGOT) and ALT (SGPT)≤2.5 × ULN (≤5 × ULN for participants with liver
                  metastases)

               7. International normalized ratio (INR) OR prothrombin time (PT), Activated partial
                  thromboplastin time (aPTT)≤1.5 × ULN unless participant is receiving
                  anticoagulant therapy as long as PT or aPTT is within therapeutic range of
                  intended use of anticoagulants

        Exclusion Criteria:

          -  Participant has mucinous, germ cell, or borderline tumor of the ovary

          -  Participant has a known or suspected deleterious mutation (germline or somatic) in
             either BRCA1 or BRCA2

          -  Participant has a history of non-infectious pneumonitis that required treatment with
             steroids or currently has pneumonitis

          -  Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or
             has features suggestive of MDS/AML

          -  Participant has a known additional malignancy that is progressing or has required
             active treatment within the past 3 years

          -  Participant has known active CNS metastases and/or carcinomatous meningitis

          -  Participant has a known history of active TB (Bacillus Tuberculosis)

          -  Participant has a known history of Hepatitis B (defined as Hepatitis B surface antigen
             [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative]
             is detected) infection

          -  Participant has uncontrolled hypertension, defined as systolic > 140 mmHg or diastolic
             > 90 mmHg documented by 2 blood pressure readings taken at least 1 hour apart

          -  Participant has a history of hemorrhage, hemoptysis or active gastrointestinal
             bleeding within 6 months prior to randomization
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:progression-free survival(6 months PFS rate)
Time Frame:6 months
Safety Issue:
Description:To determine the clinical effectiveness of the study treatment assessed using progression free survival(6months) according to RECIST v1.1 criteria (Investigator determined)

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Up to 1year
Safety Issue:
Description:
Measure:Time to tumour progression (TTP)
Time Frame:Up to 1year
Safety Issue:
Description:
Measure:Time to first subsequent treatment(or death)
Time Frame:The date of first documented first subsequent treatment or date of death, assessed up to 72 months
Safety Issue:
Description:
Measure:Time to second subsequent treatment
Time Frame:The date of first documented second subsequent treatment assessed up to 72 months
Safety Issue:
Description:
Measure:progression-free survival
Time Frame:Up to 1year
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Yonsei University

Trial Keywords

  • BRCA wild type
  • ovarian cancer
  • Platinum-sensitive

Last Updated

April 22, 2020