Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer

Sponsor
AGO Research GmbH
Study ID
NCT03353831
Phase
PHASE3
Status
Completed

Conditions

  • Recurrent Ovarian Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab will be administered by intravenouse route at a dose of 10mg/kg q14 during the treatment period
  • Atezolizumab — DRUG
    Atezolizumab will be administered by intravenous route at a dose of 840 mg q14 during the treatment period
  • Chemotherapy — DRUG
    Chemotherapy (Paclitaxel or PLD) will be administered by intravenous route at different doses during the treatment period q28
  • Placebos — DRUG
    Placebo will be administered by intravenous route q14 during the treatment period

Study Details

This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.

Key Dates

Start date
Sep 11, 2018
Status verified
Apr 2025
Primary completion
Mar 11, 2025
Completion
Mar 11, 2025

Study Design

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

Arms

  • Placebo Comparator: Arm A: Chemotherapy + Bevacizumab + Placebo
    Chemotherapy: Paclitaxel 80 mg/m² d1, 8, 14, 22 q28 or pegylated liposomal doxorubicin 40 mg/m² q28 + Bevacizumab 10 mg/kg q14 + Placebos q14
  • Experimental: Arm B: Chemotherapy + Bevacizumab + Atezolizumab
    Chemotherapy: Paclitaxel 80 mg/m² d1, 8, 14, 22 q28 or pegylated liposomal doxorubicin 40 mg/m² q28 + Bevacizumab 10 mg/kg q14 + Atezolizumab 840 mg q14

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomizationrandomization to date of death from any cause assessed up to 40 months ]

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