NCT02580058|CompletedPhase 3Results

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER

Pfizer ClinicalTrials.gov

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3 other identifiers

B99910092015-003091-77JAVELIN OVARIAN 200

Study Type

interventional

Target

566

Locations

24 countries

Sites

276

Timeline

RegisteredOct 2015

StartedDec 2015

CompletionJul 2022

Brief Summary

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

566

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline

Completed

Started Dec 2015

Typical duration for phase_3 ovarian-cancer

Geographic Reach

24 countries

276 active sites

Status

completed

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

6.6 years study duration

First Submitted

Initial submission to the registry

October 16, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed

2 months until next milestone

Study Start

First participant enrolled

December 21, 2015

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 19, 2019

Completed

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed

Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

October 16, 2015

Results QC Date

September 9, 2019

Last Update Submit

June 20, 2023

Conditions

Ovarian Cancer

Keywords

platinum resistantplatinum refractory

Outcome Measures

Primary Outcomes (2)

Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.
From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).
Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.
From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.

Secondary Outcomes (27)

Objective Response Rate (ORR) Based on BICR Assessment
Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.
ORR Based on Investigator Assessment
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
PFS Based on Investigator Assessment According to RECIST Version 1.1
From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.
Duration of Response (DR) Based on BICR Assessment
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
DR Based on Investigator Assessment
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
+22 more secondary outcomes

Study Arms (3)

avelumab

EXPERIMENTAL

Arm A: avelumab alone

Biological: avelumab

avelumab plus pegylated liposomal doxorubicin (PLD)

EXPERIMENTAL

Arm B: avelumab plus PLD

Biological: avelumabDrug: PLD

PLD

ACTIVE COMPARATOR

Arm C: PLD alone

Drug: PLD

Interventions

avelumabBIOLOGICAL

10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles

avelumabavelumab plus pegylated liposomal doxorubicin (PLD)

PLDDRUG

PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles

Also known as: doxorubicin, caelyx

PLDavelumab plus pegylated liposomal doxorubicin (PLD)

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

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

You may qualify if:

Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.

You may not qualify if:

Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (295)

Arizona Oncology Associates, PC - HAL

Chandler, Arizona, 85224, 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

University of California, Irvine/UC Irvine Health

Orange, California, 92868, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Sansum Clinic

Solvang, California, 93463, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers

Boulder, Colorado, 80303, United States

Location

Rocky Mountain Cancer Centers

Lakewood, Colorado, 80228, United States

Location

Florida Cancer Specialists

Daytona Beach, Florida, 32117, United States

Location

Florida Cancer Specialists

Wellington, Florida, 33414, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Atlanta Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location

Northside Hospital - Pharmacy

Atlanta, Georgia, 30342, United States

Location

University Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location