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)

• ClinicalTrials.gov Identifier: NCT02580058
• Recruitment Status: Completed
• First Posted: October 20, 2015
• Results First Posted: November 19, 2019
• Last Update Posted: July 10, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Biological: avelumab; Drug: PLD	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 566 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: December 21, 2015
• Actual Primary Completion Date: September 19, 2018
• Actual Study Completion Date: July 12, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: avelumab; Arm A: avelumab alone	Biological: avelumab; 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
Experimental: avelumab plus pegylated liposomal doxorubicin (PLD); Arm B: avelumab plus PLD	Biological: avelumab; 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles; Drug: 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; Other Name: doxorubicin, caelyx
Active Comparator: PLD; Arm C: PLD alone	Drug: 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; Other Name: doxorubicin, caelyx

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: 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). ]
   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.
2. Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: 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. ]
   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.

Secondary Outcome Measures :

1. Objective Response Rate (ORR) Based on BICR Assessment [ Time Frame: 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. ]
   Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.
2. ORR Based on Investigator Assessment [ Time Frame: 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. ]
   Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.
3. PFS Based on Investigator Assessment According to RECIST Version 1.1 [ Time Frame: 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. ]
   PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.
4. Duration of Response (DR) Based on BICR Assessment [ Time Frame: 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 is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
5. DR Based on Investigator Assessment [ Time Frame: 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 is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
6. Disease Control (DC) Rate Based on BICR Assessment [ Time Frame: 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. ]
   Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.
7. DC Rate Based on Investigator Assessment [ Time Frame: 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. ]
   Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.
8. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022. ]
   An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.
9. Number of Participants With Laboratory Abnormalities [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
   The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).
10. Change From Baseline in Vital Signs - Blood Pressure [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
    Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.
11. Change From Baseline in Vital Signs - Pulse Rate [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
    Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.
12. Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. ]
    Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms.
13. Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline [ Time Frame: Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. ]
    LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized.
14. Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS [ Time Frame: Biomarkers are measured only at screening. ]
    PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells.
15. Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS [ Time Frame: Biomarkers are measured only at screening. ]
    Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor.
16. Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL [ Time Frame: Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018. ]
    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.
17. Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28 [ Time Frame: From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. ]
    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28.
18. Change From Baseline in EQ-VAS Score at End of Treatment [ Time Frame: Baseline and end of treatment/withdrawal visit ]
    The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.
19. Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose [ Time Frame: At predose (0 H) on Cycle 2 Day 1 ]
    Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.
20. Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose [ Time Frame: At postdose (end of infusion, 1H) on Cycle 2 Day 1 ]
    Cmax was defined as maximum observed serum concentration, and can be observed directly from data.
21. Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose ]
    Cmax was defined as maximum observed serum concentration, and can be observed directly from data.
22. Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From 0 through 24 hours postdose ]
    AUC24 was defined as area under the concentration time profile from time zero to 24 hours.
23. Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose ]
    AUC336 was defined as area under the concentration time profile from time zero to 336 hours.
24. Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose [ Time Frame: From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose ]
    AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).
25. Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA) [ Time Frame: At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab ]
    Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.
26. Number of Participants With Treatment-Induced ADA [ Time Frame: At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab ]
    Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.
27. Number of Participants With Treatment-Induced Neutralizing Antibody (nAb) [ Time Frame: At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab ]
    Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Arizona Oncology Associates, PC - HAL

Chandler, Arizona, United States, 85224

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States, 85016

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States, 85027

Arizona Oncology Associates, PC - HAL

Scottsdale, Arizona, United States, 85258

Arizona Oncology Associates, PC-HAL

Tempe, Arizona, United States, 85284

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States, 85704

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States, 85711

United States, Arkansas

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

United States, California

University of California, Irvine/UC Irvine Health

Orange, California, United States, 92868

Sansum Clinic

Santa Barbara, California, United States, 93105

Sansum Clinic

Solvang, California, United States, 93463

United States, Colorado

Rocky Mountain Cancer Centers

Aurora, Colorado, United States, 80012

Rocky Mountain Cancer Centers

Boulder, Colorado, United States, 80303

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States, 80228

United States, Florida

Florida Cancer Specialists

Daytona Beach, Florida, United States, 32117

Florida Cancer Specialists

Wellington, Florida, United States, 33414

Florida Cancer Specialists

West Palm Beach, Florida, United States, 33401

United States, Georgia

Atlanta Gynecologic Oncology

Atlanta, Georgia, United States, 30342

Northside Hospital - Pharmacy

Atlanta, Georgia, United States, 30342

University Gynecologic Oncology

Atlanta, Georgia, United States, 30342

Northwest Georgia Oncology Centers, P.C.

Austell, Georgia, United States, 30106

Northwest Georgia Oncology Centers, P.C.

Carrollton, Georgia, United States, 30117

Northwest Georgia Oncology Centers, P.C.

Cartersville, Georgia, United States, 30121

Northwest Georgia Oncology Centers, P.C.

Douglasville, Georgia, United States, 30134

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, United States, 30060

United States, Kansas

The University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

The University of Kansas Cancer Center and Medical Pavilion

Westwood, Kansas, United States, 66205

United States, Kentucky

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, United States, 40202

Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D

Louisville, Kentucky, United States, 40202

Norton Hospital

Louisville, Kentucky, United States, 40202

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States, 40207

Norton Women's and Children's Hospital

Louisville, Kentucky, United States, 40207

Norton Brownsboro Hospital

Louisville, Kentucky, United States, 40241

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, United States, 40241

United States, Maryland

Maryland Oncology Hematology, P.A.

Bethesda, Maryland, United States, 20817

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States, 21044

Maryland Oncology Hematology P.A.

Silver Spring, Maryland, United States, 20902

Maryland Oncology Hematology P.A.

Silver Spring, Maryland, United States, 20904

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Brigham Women's Hospital

Boston, Massachusetts, United States, 02115

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Missouri

The University of Kansas Cancer Center, CCP - North

Kansas City, Missouri, United States, 64154

United States, Nevada

Center of Hope at Renown Regional Medical Center

Reno, Nevada, United States, 89502

United States, New Mexico

Southwest GYN Oncology Associates, Inc.

Albuquerque, New Mexico, United States, 87106

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States, 87106

United States, North Carolina

Hope Women's Cancer Centers

Asheville, North Carolina, United States, 28806

Mission Hospital, Inc.

Asheville, North Carolina, United States, 28806

Novant Health Oncology Specialists

Kernersville, North Carolina, United States, 27284

Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44106

Fairview Hospital Moll Pavilion Cancer Center

Cleveland, Ohio, United States, 44111

Fairview Hospital Moll Pavilion Pharmacy

Cleveland, Ohio, United States, 44111

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Hillcrest Hospital Hirsch Cancer Center Pharmacy

Mayfield Heights, Ohio, United States, 44124

Hillcrest Hospital

Mayfield Heights, Ohio, United States, 44124

United States, Oregon

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States, 97401

United States, Pennsylvania

Investigational Drug Services, University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

The University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States, 19104

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

United States, Tennessee

Tennessee Oncology, PLLC

Dickson, Tennessee, United States, 37055

Tennessee Oncology, PLLC

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC

Gallatin, Tennessee, United States, 37066

Tennessee Oncology, PLLC

Hermitage, Tennessee, United States, 37076

Tennessee Oncology, PLLC

Lebanon, Tennessee, United States, 37090

Tennessee Oncology, PLLC

Murfreesboro, Tennessee, United States, 37129

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

The Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37205

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37207

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37211

Tennessee Oncology, PLLC

Shelbyville, Tennessee, United States, 37160

Tennessee Oncology, PLLC

Smyrna, Tennessee, United States, 37167

United States, Texas

Texas Oncology-Austin Central

Austin, Texas, United States, 78731

Texas Oncology-South Austin

Austin, Texas, United States, 78745

Texas Oncology - Bedford

Bedford, Texas, United States, 76022

Texas Oncology -Fort Worth Cancer Center

Fort Worth, Texas, United States, 76104

US Oncology Investigational Products Center (IPC)

Irving, Texas, United States, 75063

US Oncology Investigational Products Center

Irving, Texas, United States, 75063

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, United States, 78240

Texas Oncology - The Woodlands, Gynecologic Oncology

The Woodlands, Texas, United States, 77380

United States, Utah

Utah Cancer Specialists

Salt Lake City, Utah, United States, 84106

United States, Virginia

Carilion Clinic Gynecologic Oncology

Roanoke, Virginia, United States, 24016

Carilion Clinic

Roanoke, Virginia, United States, 24016

United States, Wisconsin

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

Epic Pharmacy,Newcastle Private Hospital

New Lambton Heights, New South Wales, Australia, 2305

Newcastle Private Hospital Pty Limited

Newcastle, New South Wales, Australia, 2305

Australia, Queensland

Icon Cancer Care Wesley

Auchenflower, Queensland, Australia, 4066

Rivercity Pharmacy

Auchenflower, Queensland, Australia, 4066

Mater Pharmacy Services

Brisbane, Queensland, Australia, 4101

Icon Cancer Care Chermside

Chermside, Queensland, Australia, 4032

Clinical Research Unit

Herston, Queensland, Australia, 4029

Metro North Hospital and Health Service

Herston, Queensland, Australia, 4029

Oncology Pharmacy

Herston, Queensland, Australia, 4029

Icon Cancer Care

South Brisbane, Queensland, Australia, 4101

Icon Cancer Foundation

South Brisbane, Queensland, Australia, 4101

Mater Cancer Care Centre

South Brisbane, Queensland, Australia, 4101

Icon Cancer Care Southport

Southport, Queensland, Australia, 4215

Australia, Victoria

Cabrini Health Limited

Brighton, Victoria, Australia, 3186

Cabrini Health Limited

Malvern, Victoria, Australia, 3144

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Pharmacy Department

Parkville, Victoria, Australia, 3052

The Royal Women's Hospital

Parkville, Victoria, Australia, 3052

Austria

Medizinische Universitat Graz, LKH-Univ. Klinikum Graz

Graz, Austria, 8036

Medizinische Universitat Innsbruck

Innsbruck, Austria, 6020

Belgium

University Hospital Gent

Gent, EAST Flanders, Belgium, 9000

Institut Jules Bordet

Brussels, Belgium, 1000

AZ Groeninge Hospital

Kortrijk, Belgium, 8500

Universitaire Ziekenhuizen Leuven

Leuven, Belgium, 3000

CHU de Liege - Sart Tilman

Liege, Belgium, 4000

Clinique et Maternite Sainte Elisabeth

Namur, Belgium, 5000

Canada, Alberta

Tom Baker Cancer Centre

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

Kelowna, British Columbia, Canada, V1Y5L3

British Columbia Cancer Agency-Vancouver Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Manitoba

St. Boniface General Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 1R9

CancerCare Manitoba

Winnipeg, Manitoba, Canada, R3E 0V9

Canada, Nova Scotia

Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada, B3H 1V7

Nova Scotia Health Authority, QEII Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 2Y9

Canada, Ontario

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada, H4A 3J1

Oncology Pharmacy McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Czechia

Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika

Praha 2, Czech Republic, Czechia, 120 00

Fakultni nemocnice Olomouc

Olomouc, Czechia, 779 00

Fakultni nemocnice Ostrava

Ostrava-Poruba, Czechia, 708 52

Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,

Praha 2, Czechia, 120 00

Vseobecna fakultni nemocnice v Praze, Neurologicka klinika

Praha 2, Czechia, 120 00

Vseobecna fakultni nemocnice v Praze

Praha 2, Czechia, 12851

Fakultni nemocnice v Motole

Praha 5, Czechia, 150 06

Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z

Usti nad Labem, Czechia, 401 13

Denmark

Aalborg University Hospital

Aalborg, Denmark, 9000

Rigshospitalet

Copenhagen, Denmark, 2100

France

Centre Francois Baclesse

Caen Cedex 5, France, 14076

Centre Leon Berard

Lyon cedex 08, France, 69373

Service de Radiologie

LYON cedex 8, France, 69373

Centre Antoine Lacassagne

Nice cedex 2, France, 06189

Hôpital Européen Georges Pompidou

Paris cedex 15, France, 75908

Hôpital Européen Georges Pompidou

Paris, France, 75015

Centre Hospitalier Lyon Sud

Pierre Benite cedex, France, 69310

Institut de Cancérologie de Lorraine

Vandoeuvre-lès-Nancy, France, 54519

Gustave Roussy Cancer Campus

Villejuif cedex, France, 94805

Greece

General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology

Athens/New Kifissia, Greece, 14564

General Hospital of Athens Alexandra

Athens, Greece, 11528

Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

University of Hong Kong

Hong Kong, Hong Kong

Hungary

Orszagos Onkologiai Intezet, Gyogyszertar

Budapest, Hungary, 1122

Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

Budapest, Hungary, 1122

Debreceni Egyetem Klinikai Gyogyszertar

Debrecen, Hungary, 4032

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont

Szolnok, Hungary, 5000

Ireland

Mater Misericordiae University Hospital

Dublin 7, Dublin, Ireland, 7

Mater Private Hospital

Dublin 7, Dublin, Ireland, Dublin 7

Pharmacy Department

Dublin 4, Ireland

St Vincent's University Hospital

Dublin 4, Ireland

St James's Hospital

Dublin, Ireland, 8

Mater Misericoridae University Hospital

Dublin, Ireland, D7

Mater Private Hospital

Dublin, Ireland, D7

University Hospital Waterford

Waterford, Ireland

Israel

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Italy

Poliambulatorio Specialistico Villa Salute

Manerbio, Brescia, Italy, 25025

Congregazione delle Suore Infermiere dell'Addolorata

Costa Masnaga, Lecco, Italy, 23845

ASST Fatebenefratelli Sacco

Miano, Milano, Italy, 20121

Servizio Sanitario Regionale Emilia-Romagna

Lugo, Ravenna, Italy, 48022

Fondazione del Piemonte per l'Oncologia

Candiolo, Torino, Italy, 10060

Habilita, San Marco Bergamo

Bergamo, Italy, 24122

Humanitas Cliniche Gavazzeni

Bergamo, Italy, 24125

Humanitas, Unita Operativa di Cardiologia 2

Bergamo, Italy, 24125

Fondazione Poliambulanza Istituto Ospedelario

Brescia, Italy, 25124

Congregazione delle Suore Infermiere dell'Addolorata

Como, Italy, 22100

Fondazione Teresa Camplani

Cremona, Italy, 26100

Regione Lombardia, A O Istituti Ospitalieri di Cremona

Cremona, Italy, 26100

Regione Lombardia, ASST Cremona

Cremona, Italy, 26100

Istituto Europeo di Oncologia

Milano, Italy, 20141

Ambulatorio dott. Francesco Cavanna, Medico Chirurgo

Piacenza, Italy, 29121

Azienda Unita Sanitaria Locale di Piacenza

Piacenza, Italy, 29121

Azienda USL 4 Prato

Prato, Italy, 59100

Azienda USL 4 Toscana Centro

Prato, Italy, 59100

Servizio Sanitario Regionale Emilia-Romagna

Rimini, Italy, 47921

C D C, Sede di Torino Centro

Torino, Italy, 10122

Japan

Shikoku Cancer Center

Matsuyama, Ehime, Japan, 791-0280

Ehime University Hospital

Toon, Ehime, Japan, 791-0295

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

Hyogo Cancer Center

Akashi, Hyogo, Japan, 673-8558

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan, 305-8576

Tokai University Hospital

Isehara, Kanagawa, Japan, 259-1193

Nippon Medical School Musashikosugi Hospital

Kawasaki, Kanagawa, Japan, 211-8533

Yokohama City University Hospital

Yokohama, Kanagawa, Japan, 236-0004

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan, 350-1298

Saitama Cancer Center

Kita-adachi-gun, Saitama, Japan, 362-0806

National Defense Medical College Hospital

Tokorozawa, Saitama, Japan, 359-8513

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan, 430-8558

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan, 329-0498

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan, 113-8655

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan, 104-0045

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Kagoshima City Hospital

Kagoshima, Japan, 890-8760

Niigata Cancer Center Hospital

Niigata, Japan, 951-8566

Korea, Republic of

National Cancer Center

Goyangsi, Gyeonggi-do, Korea, Republic of, 10408

Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center

Daegu, Korea, Republic of, 41931

Keimyung University Dongsan Medical Center

Daegu, Korea, Republic of, 41931

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy

Seoul, Korea, Republic of, 03722

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center Clinical Trial Pharmacy

Seoul, Korea, Republic of, 06351

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

The Catholic University of Korea

Seoul, Korea, Republic of, 06591

Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 AP

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

LUMC

Leiden, Netherlands, 2333 ZA

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands, 6229 HX

Norway

Department of Obstetrics and Gynecology, Haukeland University Hospital

Bergen, Norway, 5021

Sykehusapoteket i Bergen

Bergen, Norway, 5053

Oslo Universitetssykehus

Oslo, Norway, 0379

Sykehusapoteket Oslo

Oslo, Norway, 0379

Poland

Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna

Krakow, Poland, 31-115

Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie

Krakow, Poland, 31-115

Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna

Olsztyn, Poland, 10-561

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, Poland, 10-561

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w

Poznan, Poland, 60-569

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

Poznan, Poland, 60-569

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna

Rybnik, Poland, 44-200

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

Rybnik, Poland, 44-200

Russian Federation

State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare

Sochi, Krasnodar Region, Russian Federation, 354057

State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary

Pyatigorsk, Stavropol Region, Russian Federation, 357502

Evimed Llc

Chelyabinsk, Russian Federation, 454048

State Budgetary Healthcare Institution

Chelyabinsk, Russian Federation, 454087

State Budgetary Healthcare Institution "Clinical oncology dispensary #1"

Krasnodar, Russian Federation, 350040

Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"

Moscow, Russian Federation, 115478

State Budgetary Healthcare Institution of Nizhegorogsky region

Nizhniy Novgorod, Russian Federation, 603081

State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"

Orenburg, Russian Federation, 460021

State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center

Saint Petersburg, Russian Federation, 197758

State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"

Velikiy Novgorod, Russian Federation, 173016

Singapore

National University Hospital

Singapore, Singapore, 119074

National University Hospital

Singapore, Singapore, 119082

National Cancer Centre Singapore Pharmacy

Singapore, Singapore, 169610

National Cancer Centre Singapore

Singapore, Singapore, 169610

Raffles Hospital

Singapore, Singapore, 188770

Spain

Institut Catala d'Oncologia - Hospital Duran y Reynalds

L'Hospitalet de Llobregat, Barcelona, Spain, 08908

Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta

Girona, Spain, 17007

Hospital MD Anderson

Madrid, Spain, 28033

Hospital Universitario La Paz

Madrid, Spain, 28046

Centro Integral Oncologico Clara Campal

Madrid, Spain, 28050

Hospital Universitario Virgen de Valme

Sevilla, Spain, 41014

Switzerland

Universitatsspital Basel, Frauenklinik

Basel, Basel-stadt, Switzerland, 4031

Universitatsspital Basel

Basel, Basel-stadt, Switzerland, 4031

Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie

Luzern 16, Luzern, Switzerland, 6000

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Ticino, Switzerland, 6500

Kantonsapotheke Zurich

Zurich, Switzerland, 8006

Universitaetsspital Zurich, Klinik fuer Gynakologie

Zurich, Switzerland, 8091

Universitatsspital Zurich, Clinical Trials Center

Zurich, Switzerland, 8091

Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie

Zurich, Switzerland, 8091

Universitatsspital Zurich, Universitares Herzzentrum Zurich

Zurich, Switzerland, 8091

Taiwan

Clinical Trial Pharmacy, National Cheng Kung University Hospital

Tainan city, Taiwan, 701

National Cheng Kung University Hospital

Tainan City, Taiwan, 704

National Taiwan University Hospital

Taipei city, Taiwan, 100

Clinical Trial Pharmacy, Mackay Memorial Hospital

Taipei City, Taiwan, 10449

Mackay Memorial Hospital

Taipei City, Taiwan, 104

Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center

Taipei City, Taiwan, 11259

Koo Foundation Sun Yat-Sen Cancer Center

Taipei City, Taiwan, 112

National Taiwan University Hospital

Taipei, Taiwan, 100

Clinical Trial Pharmacy, Taipei Veterans General Hospital

Taipei, Taiwan, 112

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan City, Taiwan, 333

Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch

Taoyuan City, Taiwan, 333

United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Ross Hall Hospital

Glasgow, CITY OF Glasgow, United Kingdom, G52 3NQ

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY

The Clatterbridge Cancer Centre

Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY

East and North Hertfordshire NHS Trust

Northwood, Middlesex, United Kingdom, HA6 2RN

Northampton General Hospital NHS Trust

Northampton, Northamptonshire, United Kingdom, NN1 5BD

Oxford University Hospitals NHS Foundation Trust

Headington, Oxford, United Kingdom, OX3 7LE

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom, SM2 5PT

Spire Healthcare Limited (St. Anthony's Hospital)

Sutton, Surrey, United Kingdom, SM3 9DW

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, G12 0YN

University College London Hospital NHS Foundation Trust

London, United Kingdom, NW1 2PG

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 9RT

Guy's & St. Thomas' NHS Foundation Trust

London, United Kingdom, SE1 9RT

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Imperial College Healthcare NHS Trust

London, United Kingdom, W12 0HS

University College London Hospital NHS Foundation Trust

London, United Kingdom, WC1E 6AG

The Christie Hospital NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom, NG5 1PB

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG5 1PB

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] March 4, 2019

Statistical Analysis Plan  [PDF] December 13, 2017

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02580058
• Other Study ID Numbers: B9991009; 2015-003091-77 ( EudraCT Number ); JAVELIN OVARIAN 200 ( Other Identifier: Alias Study Number )
• First Posted: October 20, 2015
• Results First Posted: November 19, 2019
• Last Update Posted: July 10, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:

platinum resistant; platinum refractory

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Doxorubicin; Avelumab; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological