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

Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study ID
NCT03806049
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    given orally once daily
  • Bevacizumab — DRUG
    given as iv infusion every three weeks
  • TSR042 — DRUG
    Given as IV infusion every three weeks
  • Carboplatin — DRUG
    given as iv infusion every three weeks
  • Paclitaxel — DRUG
    given as iv infusion every three weeks

Study Details

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

Key Dates

Start date
Dec 31, 2019
Status verified
Sep 2019
Primary completion
Dec 31, 2022
Completion
Dec 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: triplet
    chemotherapy-free combination of niraprib + bevacizumab + Dostarlimab
  • Experimental: B: Doublet
    chemotherapy-free combination of niraparib + bevacizumab
  • Active Comparator: C: standard of care
    Standard of care chemotherapy: Carboplatin + paclitaxel

Primary Outcome Measure

Progression-free Survival [ Time Frame: 42 months ]

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