NCT03695380 - A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 9, 2019

Primary Completion Date

July 12, 2023

Study Completion Date

July 12, 2023

Conditions

OVARIAN CANCER

Interventions

DRUG

Cobimetinib

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).

DRUG

Niraparib

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).

DRUG

Atezolizumab

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).

Trial Locations (20)

15009

Centro Oncologico de Galicia COG; Medical Oncology, A Coruña

17007

ICO Girona, Girona

20141

Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative, Milan

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaén

28027

Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28040

Hospital Clinico San Carlos; Servicio de Oncologia, Madrid

32224

Mayo Clinic-Jacksonville, Jacksonville

32804

Florida Hospital Cancer Institute; Clinical Research Department, Orlando

37203

Tennessee Oncology; Sarah Cannon Research Institute, Nashville

46010

Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia

53226

Medical College of Wisconsin; Department of Obstetrics and Gynecology, Milwaukee

63108

Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology, St Louis

73104

Stephenson Cancer Center Investigational Pharmacy, Oklahoma City

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

85719

University of Arizona Cancer Center, North, Tucson

92093

Moores Cancer Center at UC San Diego Health, La Jolla

30912-3335

Medical College of Georgia; Obstetrics & Gynecolog, Augusta

00168

"Fondazione Policlinico Universitario A. Gemelli; Unità di Fase 1: Unità di Farmacologia Clinica", Rome

08035

Hospital Universitari Vall dHebron; Oncology, Barcelona

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY