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COMPLETEDPHASE1

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

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

NCT03695380•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Ability to comply with the study protocol, in the investigator's judgment
•Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient-reported outcome questionnaires
•Histological diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
•Previous treatment with a minimum of one and a maximum of two prior platinum based treatment regimens
•Platinum-sensitive disease
•Availability of tumor biopsy tissue prior to first dose of study treatment with confirmation by the central laboratory that the sample is not only of adequate quality but also assignable to a molecularly defined subgroup based on breast cancer susceptibility gene (BRCA) and loss of heterozygosity (LOH) status
•Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
•Adequate hematologic and organ function
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Life expectancy of at least 12 weeks
+5 more criteria

Exclusion Criteria

•Prior treatment with mitogen-activated protein kinase inhibitor, polyadenosine diphosphate-ribose polymerase inhibitor, or immune checkpoint inhibitor therapies
•Prior chemotherapy, hormonal therapy, radiotherapy, antibody therapy, or other immunotherapy, gene therapy, vaccine therapy, or treatment with experimental drugs within 14 days prior to first dose of study treatment
•Treatment with systemic immunostimulatory agents within 28 days or 5 half-lives of the drug prior to initiation of study treatment
•Treatment with systemic immunosuppressive medication 14 days prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study
•History of other malignancy that could affect compliance with the protocol or interpretation of results, or known to have potentially fatal outcome
•Symptomatic and/or untreated central nervous system metastases
•Surgical procedure, significant traumatic injury within 14 days prior to enrollment, or anticipation of need for major surgical procedure during the study
•Minor surgical procedure within 3 days
•History or evidence of retinal pathology on ophthalmic examination
•Left ventricular ejection fraction below institutional lower limit of normal
+15 more criteria

Locations (20)

University of Arizona Cancer Center, North

Tucson, Arizona, United States

Moores Cancer Center at UC San Diego Health

La Jolla, California, United States

Mayo Clinic-Jacksonville

Jacksonville, Florida, United States

Florida Hospital Cancer Institute; Clinical Research Department

Orlando, Florida, United States

Medical College of Georgia; Obstetrics & Gynecolog

Augusta, Georgia, United States

Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

St Louis, Missouri, United States

Stephenson Cancer Center Investigational Pharmacy

Oklahoma City, Oklahoma, United States

Tennessee Oncology; Sarah Cannon Research Institute

Nashville, Tennessee, United States

Medical College of Wisconsin; Department of Obstetrics and Gynecology

Milwaukee, Wisconsin, United States

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Campania, Italy

Key Dates

Start Date

January 9, 2019

Primary Completion Date

July 12, 2023

Completion Date

July 12, 2023

Last Updated

August 14, 2023

Enrollment

ACTUAL participants

Conditions

OVARIAN CANCER

Interventions

Cobimetinib

DRUG

Niraparib

DRUG

Atezolizumab

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)