NCT02718417|TerminatedPhase 3ResultsDMC

Study Stopped

The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.

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

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

Pfizer ClinicalTrials.gov

Compare

3 other identifiers

B99910102015-003239-36JAVELIN OVARIAN 100

Study Type

interventional

Target

998

Locations

25 countries

Sites

319

Timeline

RegisteredMar 2016

StartedMay 2016

CompletionMay 2019

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

998

participants targeted

Target at P75+ for phase_3 ovarian-cancer

Timeline

Completed

Started May 2016

Shorter than P25 for phase_3 ovarian-cancer

Geographic Reach

25 countries

319 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

March 15, 2016

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

May 19, 2016

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2018

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed

7 months until next milestone

Results Posted

Study results publicly available

December 18, 2019

Completed

Last Updated

July 14, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

March 15, 2016

Results QC Date

September 6, 2019

Last Update Submit

June 19, 2020

Conditions

Ovarian Cancer

Keywords

untreated epithelial ovarianfallopian tubeprimary peritoneal cancer

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

Secondary Outcomes (35)

Overall Survival
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Progression-Free Survival (PFS) as Assessed by Investigator
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
Percentage of Participants With Objective Response as Assessed by Investigator
Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)
Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)
Duration of Response (DOR) as Assessed by Investigator
First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
+30 more secondary outcomes

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Chemotherapy followed by observation

Drug: carboplatinDrug: paclitaxel

Arm B

EXPERIMENTAL

Chemotherapy followed by avelumab in maintenance

Drug: carboplatinDrug: paclitaxelDrug: Avelumab

Arm C

EXPERIMENTAL

Chemotherapy in combination with avelumab followed by avelumab in maintenance

Drug: carboplatinDrug: paclitaxelDrug: Avelumab

Interventions

carboplatinDRUG

Given Q3W during chemotherapy phase

Arm AArm BArm C

paclitaxelDRUG

Investigator choice of weekly or Q3W during chemotherapy phase

Arm AArm BArm C

AvelumabDRUG

Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion

Arm C

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (319)

Alabama Oncology

Alabaster, Alabama, 35007, United States

Location

Alabama Oncology

Bessemer, Alabama, 35022, United States

Location

Alabama Oncology, Bruno Cancer Center

Birmingham, Alabama, 35205, United States

Location

Alabama Oncology

Birmingham, Alabama, 35209, United States

Location

Alabama Oncology

Birmingham, Alabama, 35211, United States

Location

Alabama Oncology

Birmingham, Alabama, 35235, United States

Location

Alabama Oncology

Birmingham, Alabama, 35243, United States

Location

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, 85027, United States

Location

Arizona Oncology Associates, PC - HAL

Scottsdale, Arizona, 85258, United States

Location

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, 85284, United States

Location

Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, 85704, United States

Location

Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, 85711, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

Oso HomeCare

Irvine, California, 92614, United States

Location

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

Location

Medical Center, Cedars-Sinai

Los Angeles, California, 90048, United States

Location

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

Chao Family Comprehensive Cancer Center