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

Purpose

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.

Condition

  • Ovarian Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm A 		Chemotherapy followed by observation
  • Drug: carboplatin
    Given Q3W during chemotherapy phase
  • Drug: paclitaxel
    Investigator choice of weekly or Q3W during chemotherapy phase
Experimental
Arm B 		Chemotherapy followed by avelumab in maintenance
  • Drug: carboplatin
    Given Q3W during chemotherapy phase
  • Drug: paclitaxel
    Investigator choice of weekly or Q3W during chemotherapy phase
  • Drug: Avelumab
    Given as single agent in maintenance portion Q2W
Experimental
Arm C 		Chemotherapy in combination with avelumab followed by avelumab in maintenance
  • 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

More Details

Status
Terminated
Sponsor
Pfizer

Study Contact