A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03695380
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cobimetinib — DRUG
    Cobimetinib will be administered at a starting dose of 60 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle (Stage 1) and PO QD on Days 1-21 (21/7 schedule) at the established dose for the doublet regimen in Stage 1 (Stage 2).
  • Niraparib — DRUG
    Niraparib will be administered at a starting dose of 200 mg of niraparib PO QD on Days 1-28 of each 28-day cycle (Stage 1) and PO QD on Days 1-28 of each 28-day cycle at the established dose for the doublet regimen in Stage 1 (Stage 2).
  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV infusion at the fixed dose of 840 mg on Days 1 and 15 (+/-3 days) of each 28-day cycle (Stages 1 and 2).

Study Details

The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2). The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2). Stage 1 will enable patient enrollment in the randomized phase of the study (Stage 2) with both regimens at the recommended dose levels from Stage 1. Stage 2 is a randomized, dose-expansion phase, evaluating clinical outcomes in patients with advanced platinum-sensitive ovarian cancer. All patients will continue to receive study treatment until disease progression (according to "Response Evaluation Criteria in Solid Tumors" (RECIST), Version 1.1, unacceptable toxicity, death, or patient or investigator decision to withdraw, whichever occurs first.

Key Dates

Start date
Jan 9, 2019
Status verified
Aug 2023
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Cobimetinib - Niraparib
    Stage 2 - Patients will receive cobimetinib PO QD on Days 1-21 (21/7 schedule) in combination with niraparib PO QD on Days 1-28 of each 28-day cycle at the established dose for the doublet regimen in Stage 1, Cohort 1.
  • Experimental: Arm B: Cobimetinib - Niraparib - Atezolizumab
    Stage 2 - Patients will receive cobimetinib PO QD on Days 1-21 (21/7 schedule) in combination with niraparib QD on Days 1-28 at the established doses for the triplet regimen in Stage 1,Cohort 2 plus atezolizumab by IV infusion at the fixed dose of 840 mg on Days 1 and 15 (+/-3 days) of each 28-day cycle.
  • Experimental: Cohort 1 - Cobimetinib - Niraparib
    Stage 1 - Patients in Cohort 1 will be treated with cobimetinib plus niraparib. Cobimetinib: Patients will receive a starting dose of 60 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Niraparib: Patients will receive a starting dose of 200 mg of niraparib PO QD on Days 1-28 of each 28-day cycle.
  • Experimental: Cohort 2 - Cobimetinib - Niraparib - Atezolizumab
    Stage 1 - Patients in Cohort 2 will be treated with cobimetinib plus niraparib and atezolizumab. Cobimetinib: Patients will receive a starting dose of 60 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Niraparib: Patients will receive a starting dose of 200 mg of niraparib PO QD on Days 1-28 of each 28-day cycle. Atezolizumab: Patients will also receive atezolizumab administered as an IV infusion at a fixed dose of 840 mg on Days 1 and 15 (+/-3 days) of each 28-day cycle.

Primary Outcome Measure

Number of patients reporting Adverse Events (AEs) [ Time Frame: From baseline up to 48 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center, NorthTucsonArizona85719-
Moores Cancer Center at UC San Diego HealthLa JollaCalifornia92093-
Mayo Clinic-JacksonvilleJacksonvilleFlorida32224-
Florida Hospital Cancer Institute; Clinical Research DepartmentOrlandoFlorida32804-
Medical College of Georgia; Obstetrics & GynecologAugustaGeorgia30912-3335-
Washington University School of Medicine; Dept of Medicine/Div of Medical OncologySt LouisMissouri63108-
Stephenson Cancer Center Investigational PharmacyOklahoma CityOklahoma73104-
Tennessee Oncology; Sarah Cannon Research InstituteNashvilleTennessee37203-
Medical College of Wisconsin; Department of Obstetrics and GynecologyMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arizona Cancer Center, North· Tucson, AZMoores Cancer Center at UC San Diego Health· La Jolla, CAMayo Clinic-Jacksonville· Jacksonville, FLFlorida Hospital Cancer Institute; Clinical Research Department· Orlando, FLMedical College of Georgia; Obstetrics & Gynecolog· Augusta, GAWashington University School of Medicine; Dept of Medicine/Div of Medical Oncology· St Louis, MO

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