Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Pembrolizumab

Docetaxel

Albumin-Bound Paclitaxel

Olaparib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants will continue treatment period up to 6 cycles and enter maintenance period after treatment period. Study treatment will be continued until progressive disease (PD) based on RECIST 1.1, death, unacceptable toxicity, or participant withdrawal from the study.

pembrolizumab 200 mg every three weeks (Q3W)

pembrolizumab

olaparib 300 mg twice daily (BID) during maintenance period

olaparib

bevacizumab

carboplatin AUC=5 or 6 Q3W during treatment period

carboplatin

paclitaxel 175 mg/m2 Q3W during treatment period

paclitaxel

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

docetaxel

Kosei Hasegawa, MD, PhD

Miwa Hirai

Kosei Hasegawa, MD

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.

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

Phase II Study of Pembrolizumab and Bevacizumab in Combination With Platinum-based Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Exploratory assessment of relationship between biomarkers and efficacy endpoints if possible

Two-year progression-free survival rate after administration of pembrolizumab and bevacizumab in combination with PBC followed by pembrolizumab, bevacizumab and olaparib as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer based on RECIST 1.1.

PFS after administration of the study treatment based on RECIST 1.1

PFS in maintenance period in patients who assessed CR or PR at last tumor assessment before entering maintenance period based on RECIST 1.1

ORR after administration of the study treatment based on RECIST 1.1

DCR after administration of the study treatment based on RECIST 1.1

DOR after administration of the study treatment based on RECIST 1.1

One-year progression-free survival rate after administration of the study treatment based on RECIST 1.1.

OS after administration of the study treatment using Kaplan-Meier method

The number and proportion of participants with adverse events as assessed by CTCAE v5.0

Spots Global Cancer Trial Database for ovarian cancer, pembrolizumab, olaparib