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Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

NCT02718417 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 998

Last updated 2020-07-14

Study results available
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Summary

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.

The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

Conditions

Interventions

DRUG

carboplatin

Given Q3W during chemotherapy phase

DRUG

paclitaxel

Investigator choice of weekly or Q3W during chemotherapy phase

DRUG

Avelumab

Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion

DRUG

Avelumab

Given as single agent in maintenance portion Q2W

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

  • Bradley Monk, MD · Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA

  • Jonathan Ledermann, MD · UCL Cancer Institute, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-19
Primary Completion
2018-09-07
Completion
2019-05-16

Countries

  • United States
  • Bulgaria
  • Canada
  • Croatia
  • Estonia
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Latvia
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02718417 on ClinicalTrials.gov