Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)
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|ClinicalTrials.gov Identifier: NCT03642132|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Chemotherapy + avelumab followed by avelumab + talazoparib Drug: Chemotherapy followed by talazoparib maintenance Drug: Chemotherapy + bevacizumab followed by bevacizumab||Phase 3|
This is a Phase 3, randomized, open-label, multicenter study to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with the PARP inhibitor talazoparib in patients with previously untreated advanced ovarian cancer. Eligible patients must have previously untreated histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer and must be candidates for bevacizumab in combination with platinum based chemotherapy.
The primary purpose of the study is to demonstrate that avelumab in combination with platinum-based chemotherapy followed by avelumab plus talazoparib maintenance is superior to platinum-based chemotherapy plus bevacizumab followed by bevacizumab maintenance in prolonging PFS in patients with advanced ovarian cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB IN COMBINATION WITH CHEMOTHERAPY FOLLOWED BY MAINTENANCE THERAPY OF AVELUMAB IN COMBINATION WITH THE POLY (ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OVARIAN CANCER (JAVELIN OVARIAN PARP100)|
|Actual Study Start Date :||July 19, 2018|
|Estimated Primary Completion Date :||February 9, 2022|
|Estimated Study Completion Date :||May 18, 2026|
Experimental: chemotherapy, avelumab and talazoparib
Platinum-based chemotherapy + avelumab followed by avelumab + talazoparib maintenance
Drug: Chemotherapy + avelumab followed by avelumab + talazoparib
Chemotherapy Period Paclitaxel Carboplatin Avelumab
Maintenance Period Avelumab Talazoparib
Experimental: chemotherapy, and talazoparib
Platinum-based chemotherapy followed by talazoparib maintenance
Drug: Chemotherapy followed by talazoparib maintenance
Chemotherapy Period Paclitaxel Carboplatin
Maintenance Period Talazoparib
Active Comparator: chemotherapy and bevacizumab
Platinum-based chemotherapy + bevacizumab followed by bevacizumab maintenance
Drug: Chemotherapy + bevacizumab followed by bevacizumab
Chemotherapy Period Paclitaxel Carboplatin Bevacizumab
Maintenance Period Bevacizumab
- Progression-Free Survival (PFS) [ Time Frame: Baseline to measured progressive disease (up to approximately 41 months) ]The time from the date of randomization to the date of the first documentation of Progression of Disease or death due to any cause, whichever occurs first. Assessments to be completed by third-party blinded independent committee review.
- Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to approximately 93 months) ]Overall survival (OS) is time from the date of randomization to the date of death due to any cause.
- Euro Quality of Life (EQ-5D-5L) [ Time Frame: Every 3 weeks during chemotherapy period (up to 18 weeks), and every 6 weeks (up to 24 months) during maintenance and follow-up period (up to 3 years). ]Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Health State Profile which has individualsrate their level of problems (none, slight, moderate, severe, or extreme/unable) in 5 areas (mobility, self care, usual activities, pain/discomfort, and anxiety/depression).
- NFOSI-18 [ Time Frame: Day 1, 8, 15 of cycles 1,2,3 and D1 of cycles 4, 5, 6 in chemotherpy period (cycle is 21 days) and every 6 weeks (up to 24 months) during maintenance and follow-up period (up to 3 years). ]NFOSI-18 is an ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. DRS-P subscale include 9 physical symptoms/concerns (energy, pain, ill, stomach cramps, fatigue, constipation, stomach swelling, bowel control and sleep) and the disease related symptoms-emotional subscale include 1 emotional symptom/concern (worry condition will get worse). The treatment side effect subscale includes 5 items (nausea, hair loss, bothered by side effects, vomiting and skin problems). The functional well-being subscale includes 3 items (able to get around, enjoy life, and content with QoL).
- ADA (Anti-Drug Antibodies) against Avelumab [ Time Frame: Every 3 weeks during 1st 4 cycles of chemotherapy ( cycle 21 days), day 1 and 29 during 1st cycle of maintenance (cycle 42 days) and every 12 weeks (up to 60 weeks). ]The percentage of participants with positive ADA and neutralizing antibodies will be summarized in treatment Arm A. All samples that are positive for ADA will also undergo characterization for Neutralizing Antibodies (NAb).
- Progression Free Survival after the second line of therapy (PFS2) [ Time Frame: Baseline up to second progression up to approximately 41 months. ]Time from the date of randomization to the start of second subsequent treatment after first PD by Investigator assessment, or death from any cause, whichever occurs first.
- Cmax - Talazoparib [ Time Frame: Pre-dose on Days 1, 15, and 29 of Cycle 1 (Cycle is 42 days) of maintenance treatment. ]Maximum Observed Plasma Concentration (Cmax)
- Cmax - Avelumab [ Time Frame: Every 3 weeks during 1st 4 cycles of chemotherapy ( cycle 21 days), day 1 and 29 during 1st cycle of maintenance (cycle 42 days) and every 12 weeks (up to 60 weeks). ]Maximum Observed Plasma Concentration (Cmax).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642132
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
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|Study Chair:||Bradley Monk, MD||Department of Obstetrics and Gynecology, University of Arizona College of Medicine - Phoenix|
|Study Chair:||Jonathan Ledermann, MD||UCL Cancer Institute at University College London|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|