Summary

for females ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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.

Official Title

A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100

Keywords

Ovarian Canceruntreated epithelial ovarianfallopian tubeprimary peritoneal cancerOvarian NeoplasmsCarcinoma, Ovarian EpithelialPaclitaxelCarboplatinAntibodies, MonoclonalAvelumab

Eligibility

For females ages 18 years and up

Key Inclusion Criteria:

  • Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
  • Patients must be candidates for platinum based chemotherapy and previously untreated
  • Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
  • Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
  • ECOG PS 0-1
  • Adequate hematological, renal, and liver function

Key Exclusion Criteria:

  • Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
  • Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
  • Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
  • Cancer for which intraperitoneal cytotoxic chemotherapy is planned
  • Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

Locations

  • University of California, Irvine/UC Irvine Health
    OrangeCalifornia92868United States
  • Oso HomeCare
    IrvineCalifornia92614United States
  • Gynecologic Oncology Associates
    Newport BeachCalifornia92663United States
  • Chao Family Comprehensive Cancer Center
    OrangeCalifornia92868United States
  • Hematology-Oncology Medical Group of Orange County
    OrangeCalifornia92868United States
  • Medical Oncology Care Associates
    OrangeCalifornia92868United States
  • St. Joseph Hospital of Orange
    OrangeCalifornia92868United States
  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
    OrangeCalifornia92868United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT02718417
Phase
Phase 3
Study Type
Interventional
Last Updated