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Atezolizumab and Niraparib in Recurrent Ovarian Cancer (ANITA)
NCT03598270Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2018
- Primary completion
- Aug 2024
- Countries
- 5
- Sponsor
- Grupo Español de Investigación en Cáncer de Ovario
- Modality
- Monoclonal Antibodies
- Drugs
- atezolizumab
- Conditions
- ovarian cancerfallopian tube cancer (PFTC)primary peritoneal cancer (PPC)
01
Overview
Phase 3, randomised, double-blind trial of atezolizumab in ovarian cancer, fallopian tube cancer (PFTC) and primary peritoneal cancer (PPC) (2 arms), sponsored by Grupo Español de Investigación en Cáncer de Ovario. Primary endpoint: Progression-Free Survival at 30 months. Started Nov 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Control Arm
Chemotherapy + Placebo followed by Niraparib + Placebo
Experimental Arm
Chemotherapy + Tecentriq followed by Niraparib + Tecentriq
03
Who it enrols
Patients with platinum-sensitive recurrent high-grade serous or endometrioid ovarian, tubal, or peritoneal cancer who have received 1-2 prior lines of chemotherapy.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
Duration of Response
Incidence of Treatment Adverse Events
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