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Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer (OPEB-01)

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: NCT04361370
Recruitment Status : Enrolling by invitation
First Posted : April 24, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer Drug: Olaparib-Pembrolizumab-Bevacizumab Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : August 2026


Arm Intervention/treatment
Experimental: Treatment group
BRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer
Drug: Olaparib-Pembrolizumab-Bevacizumab
  • 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)




Primary Outcome Measures :
  1. progression-free survival(6 months PFS rate) [ Time Frame: 6 months ]
    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 :
  1. Overall survival (OS) [ Time Frame: Up to 1year ]
  2. Time to tumour progression (TTP) [ Time Frame: Up to 1year ]
  3. 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 ]
  4. Time to second subsequent treatment [ Time Frame: The date of first documented second subsequent treatment assessed up to 72 months ]
  5. progression-free survival [ Time Frame: Up to 1year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT04361370


Locations
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Korea, Republic of
Yonsei Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04361370    
Other Study ID Numbers: 4-2020-0386
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
BRCA wild type
ovarian cancer
Platinum-sensitive
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Bevacizumab
Pembrolizumab
Olaparib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action