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Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC)
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001/ENGOT-ov43)
 
Region Sponsors
California - Northern
Gynecologic Oncology Group
 
Acronym KP IRB No.
7339-001 1522624
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Females with histologically confirmed Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms.
 
Purpose
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and/or Overall Survival (OS), and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 and/or OS.
 
Detailed Description
Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel, participants will be randomly assigned into one of three treatment arms: •Pembrolizumab+Olaparib, •Pembrolizumab+Placebo for Olaparib, or •Placebo for Pembrolizumab+Placebo for Olaparib. At Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected: 1.up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle 2.up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or 3.up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.
 
Gender Age Limit
Female 18 years & older
 
Inclusion Criteria
  • Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (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
  • Has just completed primary debulking surgery or is eligible for primary or interval debulking surgery
  • Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
  • Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA, ng/mL) ratio greater than or equal to 25
  • Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 7 days prior to randomization
  • Is not pregnant, not breastfeeding, and 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and olaparib (or olaparib placebo) and at least 210 days following the last dose of chemotherapy or bevacizumab (if administered)
  • Has adequate organ function
 
Exclusion Criteria
  • Has mucinous, germ cell, or borderline tumor of the ovary
  • Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
  • Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
  • Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
  • Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded
  • Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >/=10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • 7339-001
  • Gonadal Disorders
  • Adnexal Diseases
  • Neoplasms
  • Carcinoma
  • Neoplasms by Site
  • Carcinoma, Ovarian Epithelial
  • Oncology (Adult)
  • Endocrine Gland Neoplasms
  • Ovarian Diseases
  • Endocrine System Diseases
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Genital Diseases, Female
  • Urogenital Neoplasms
  • Genital Neoplasms, Female
  • Obstetrics and Gynecology
  • GOG-3036
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Oakland Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Vallejo Medical Center
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Michael A Bookman, MD
Contact Information:
- Desiree Goldstein
-707-651-2797
-desiree.goldstein@kp.org
-Vallejo Medical Center


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