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A Study Of Avelumab Alone Or ...

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)

Last Updated: 2023-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-21

Study Completion Date

2022-07-12

Brief Summary

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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.

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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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avelumab

Arm A: avelumab alone

Group Type EXPERIMENTAL

avelumab

Intervention Type BIOLOGICAL

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

avelumab plus pegylated liposomal doxorubicin (PLD)

Arm B: avelumab plus PLD

Group Type EXPERIMENTAL

avelumab

Intervention Type BIOLOGICAL

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

PLD

Intervention Type DRUG

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

PLD

Arm C: PLD alone

Group Type ACTIVE_COMPARATOR

PLD

Intervention Type DRUG

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

Interventions

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avelumab

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

Intervention Type BIOLOGICAL

PLD

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

Intervention Type DRUG

Other Intervention Names

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doxorubicin, caelyx

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

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

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Research Institute

Toronto, Ontario, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Arizona Oncology Associates, PC - HAL

Chandler, Arizona, 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

University of California, Irvine/UC Irvine Health

Orange, California, United States

Site Status

Sansum Clinic

Santa Barbara, California, United States

Site Status

Sansum Clinic

Solvang, California, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

Site Status

Florida Cancer Specialists

Daytona Beach, Florida, United States

Site Status

Florida Cancer Specialists

Wellington, Florida, United States

Site Status

Florida Cancer Specialists

West Palm Beach, Florida, United States

Site Status

Atlanta Gynecologic Oncology

Atlanta, Georgia, United States

Site Status

Northside Hospital - Pharmacy

Atlanta, Georgia, United States

Site Status

University Gynecologic Oncology

Atlanta, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, P.C.

Austell, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, P.C.

Carrollton, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, P.C.

Cartersville, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, P.C.

Douglasville, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, United States

Site Status

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

Site Status