NCT03806049

Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer

ENGOT-OV42 / NSGO-AVATAR: A Three-arm Randomized Study to Evaluate the Efficacy of Niraparib-bevacizumab-dostarlimab Triplet Combination Against Niraparib-bevacizumab Doublet Combination and Against Standard of Care Therapy in Women With Relapsed Ovarian Cancer Where Platinum Combination Therapy is an Option.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

ENGOT-OV42 / NSGO-AVATAR: This three-arm randomized trial is to demonstrate efficacy of niraparib-bevacizumab-dostarlimab triplet combination against standard of care treatment and to demonstrate efficacy of niraparib-bevacizumab-dostarlimab triplet combination against niraparib-bevacizumab doublet combination for patients with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer

Detailed description

This is a multicenter randomized open-label trial to compare two different chemotherapy-free arms against standard of care treatment in patients with recurrent ovarian cancer with \>6 months of chemotherapy-free interval to prior therapy.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	given orally once daily
DRUG	Bevacizumab	given as iv infusion every three weeks
DRUG	TSR042	Given as IV infusion every three weeks
DRUG	Carboplatin	given as iv infusion every three weeks
DRUG	Paclitaxel	given as iv infusion every three weeks

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-12-01
• Completion: 2024-12-01
• First posted: 2019-01-16
• Last updated: 2021-07-15

Locations

8 sites across 3 countries: Denmark, Finland, Norway