Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Ovarian Carcinoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double-blinded, multi-center studyMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Atezolizumab and placebo treatment will be double blinded, unknown to both the subject and the study staff, including the treating physician. In order to maintain the blind, atezolizumab and placebo will be identical in appearance and packaging. The study medication will be labeled using a unique kit id number, which is linked to the randomization scheme. The active and placebo kits will be presented in the same packaging to ensure blinding of the study medication Individual treatment codes, indicating the treatment randomization for each randomized patient, will be available to the investigator(s) or pharmacists from the IVRS/IWRS. Routines for this will be described in the Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS) user manual that will be provided to each centre.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03598270
- Collaborators
- Hoffmann-La Roche
- GSK/TESARO
- AGO Study Group
- Belgian Gynaecological Oncology Group
- ARCAGY/ GINECO GROUP
- Israeli Society of Gynecologic Oncology
- MaNGO
- Investigators
- Principal Investigator: Antonio González Martín, MD PhD Clinica Universitaria de Navarra
Get Well Soon