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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.