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.
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:
4-2020-0386
- NCT ID:
NCT04361370
Conditions
- Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer
Interventions
Drug | Synonyms | Arms |
---|
Olaparib-Pembrolizumab-Bevacizumab | | Treatment 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) from 2nd infusion for up to 35 infusions
- Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment group | Experimental | BRCA 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: | Enrolling by invitation |
Lead Sponsor: | Yonsei University |
Trial Keywords
- BRCA wild type
- ovarian cancer
- Platinum-sensitive
Last Updated
April 19, 2021