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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pembrolizumab and bevacizumab with PBC followed by pembrolizumab, bevacizumab and olaparib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pembrolizumab | Biological | pembrolizumab 200 mg every three weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two-year progression-free survival rate | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS after administration of the study treatment based on RECIST 1.1 | 3 years |
| PFS in maintenance period by chemotherapy responder | PFS in maintenance period in patients who assessed CR or PR at last tumor assessment before entering maintenance period based on RECIST 1.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Exploratory assessment of relationship between biomarkers and efficacy endpoints if possible | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kosei Hasegawa, MD, PhD | Contact | +81-42-984-4111 | 5627 | koseih@saitama-med.ac.jp |
| Miwa Hirai | Contact | +81-3-6779-8222 | saint-ov02@cmic.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Kosei Hasegawa, MD, PhD | Saitama Medical University International Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saitama Medical Uiversity International Medical Center | Recruiting | Hidaka | Saitama | 3501298 | Japan |
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|
| olaparib | Drug | olaparib 300 mg twice daily (BID) during maintenance period |
|
|
| bevacizumab | Biological | bevacizumab 15 mg/kg Q3W |
|
|
| carboplatin | Drug | carboplatin AUC=5 or 6 Q3W during treatment period |
|
| paclitaxel | Drug | paclitaxel 175 mg/m2 Q3W during treatment period |
|
| docetaxel | Drug | docetaxel 60 ~ 70 mg/m2 Q3W during treatment period |
|
| 3 years |
| Objective Response Rate (ORR) | ORR after administration of the study treatment based on RECIST 1.1 | 3 years |
| Disease Control Rate (DCR) | DCR after administration of the study treatment based on RECIST 1.1 | 3 years |
| Duration of Response (DOR) | DOR after administration of the study treatment based on RECIST 1.1 | 3 years |
| One-year progression-free survival rate | One-year progression-free survival rate after administration of the study treatment based on RECIST 1.1. | 1 year |
| Overall Survival (OS) | OS after administration of the study treatment using Kaplan-Meier method | 3 years |
| Incidence of adverse events | The number and proportion of participants with adverse events as assessed by CTCAE v5.0 | 3 years |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C531550 | olaparib |
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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