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

NCT03353831 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2025-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Ovarian Carcinoma

Interventions

DRUG

Bevacizumab

Bevacizumab will be administered by intravenouse route at a dose of 10mg/kg q14 during the treatment period

DRUG

Atezolizumab

Atezolizumab will be administered by intravenous route at a dose of 840 mg q14 during the treatment period

DRUG

Chemotherapy

Chemotherapy (Paclitaxel or PLD) will be administered by intravenous route at different doses during the treatment period q28

DRUG

Placebos

Placebo will be administered by intravenous route q14 during the treatment period

Sponsors & Collaborators

Principal Investigators

  • Philipp Harter, MD, PhD · Kliniken Essen-Mitte, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2025-03-11
Completion
2025-03-11

Countries

  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Lithuania
  • Norway
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03353831 on ClinicalTrials.gov