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Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Recurrent Ovarian Cancer

NCT05158062 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-04-26

No results posted yet for this study

Summary

This trial is a multicenter, single-arm, phase II study evaluating the efficacy of pembrolizumab and bevacizumab in combination with platinum-based chemotherapy (PBC) followed by pembrolizumab, bevacizumab and olaparib as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.This study is planned to enroll eligible 35 patients from multiple study sites in Japan.

Conditions

  • Carcinoma, Ovarian Epithelial

Interventions

BIOLOGICAL

pembrolizumab

pembrolizumab 200 mg every three weeks (Q3W)

DRUG

olaparib

olaparib 300 mg twice daily (BID) during maintenance period

BIOLOGICAL

bevacizumab

bevacizumab 15 mg/kg Q3W

DRUG

carboplatin

carboplatin AUC=5 or 6 Q3W during treatment period

DRUG

paclitaxel

paclitaxel 175 mg/m2 Q3W during treatment period

DRUG

docetaxel

docetaxel 60 \~ 70 mg/m2 Q3W during treatment period

Sponsors & Collaborators

  • Kosei Hasegawa, MD, PhD

    lead OTHER

Principal Investigators

  • Kosei Hasegawa, MD, PhD · Saitama Medical University International Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158062 on ClinicalTrials.gov