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Avelumab in Previously Untrea...

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

Last Updated: 2020-07-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

998 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-19

Study Completion Date

2019-05-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Chemotherapy followed by observation

Group Type ACTIVE_COMPARATOR

carboplatin

Intervention Type DRUG

Given Q3W during chemotherapy phase

paclitaxel

Intervention Type DRUG

Investigator choice of weekly or Q3W during chemotherapy phase

Arm B

Chemotherapy followed by avelumab in maintenance

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

Given Q3W during chemotherapy phase

paclitaxel

Intervention Type DRUG

Investigator choice of weekly or Q3W during chemotherapy phase

Avelumab

Intervention Type DRUG

Given as single agent in maintenance portion Q2W

Arm C

Chemotherapy in combination with avelumab followed by avelumab in maintenance

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

Given Q3W during chemotherapy phase

paclitaxel

Intervention Type DRUG

Investigator choice of weekly or Q3W during chemotherapy phase

Avelumab

Intervention Type DRUG

Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion

Avelumab

Intervention Type DRUG

Given as single agent in maintenance portion Q2W

Interventions

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carboplatin

Given Q3W during chemotherapy phase

Intervention Type DRUG

paclitaxel

Investigator choice of weekly or Q3W during chemotherapy phase

Intervention Type DRUG

Avelumab

Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion

Intervention Type DRUG

Avelumab

Given as single agent in maintenance portion Q2W

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Bradley Monk, MD

Role: STUDY_CHAIR

Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA

Jonathan Ledermann, MD

Role: STUDY_CHAIR

UCL Cancer Institute, UK

Locations

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Alabama Oncology

Alabaster, Alabama, United States

Site Status

Alabama Oncology

Bessemer, Alabama, United States

Site Status

Alabama Oncology, Bruno Cancer Center

Birmingham, Alabama, United States

Site Status

Alabama Oncology

Birmingham, Alabama, United States

Site Status

Alabama Oncology

Birmingham, Alabama, United States

Site Status

Alabama Oncology

Birmingham, Alabama, United States

Site Status

Alabama Oncology

Birmingham, Alabama, United States

Site Status

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Scottsdale, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, United States

Site Status

Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, United States

Site Status

Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, United States

Site Status

Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status

Oso HomeCare

Irvine, California, United States

Site Status

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

Site Status

Medical Center, Cedars-Sinai

Los Angeles, California, United States

Site Status

Gynecologic Oncology Associates

Newport Beach, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Hematology-Oncology Medical Group of Orange County

Orange, California, United States

Site Status

Medical Oncology Care Associates

Orange, California, United States

Site Status

St. Joseph Hospital of Orange

Orange, California, United States

Site Status

The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

Orange, California, United States

Site Status

UC Irvine Health

Orange, California, United States

Site Status