Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

March 10, 2023 updated by: Pfizer

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)

JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.

Study Overview

Detailed Description

JAVELIN Ovarian PARP 100 (B9991030) is an open-label, international, multi-center, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The primary endpoint is progression-free survival (PFS) as determined based on blinded independent central review (BICR) assessment per RECIST v1.1.

On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study. The alliance has notified health authorities and trial investigators of the decision to discontinue the trial. The decision was based on several emerging factors since the trial's initiation, including the previously announced interim results from JAVELIN Ovarian 100 study (B9991010), which was stopped due to futility of efficacy at a planned interim analysis on 21 December 2018. The alliance determined that the degree of benefit observed with avelumab in frontline ovarian cancer in that study does not support continuation of the JAVELIN Ovarian PARP 100 trial in an unselected patient population and emphasizes the need to better understand the role of immunotherapy in ovarian cancer. Additional factors include the rapidly changing treatment landscape and the approval of a PARP inhibitor in the frontline maintenance setting. The decision to discontinue the JAVELIN Ovarian PARP 100 trial was not made for safety reasons.

Patients who remain in the study will continue receiving investigational products according to their randomized treatment assignment and will be monitored for appropriate safety assessments until treatment discontinuation.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Epworth Foundation trading as Epworth HealthCare
      • Richmond, Victoria, Australia, 3121
        • Epworth HealthCare, Clinical Trials & Research Centre
      • Namur, Belgium, 5000
        • CHU-UCL Namur/Site Sainte Elisabeth
      • Cork, Ireland, T12 DV56
        • Bon Secours Hospital
    • MI
      • Milano, MI, Italy, 20141
        • Istituto Europeo di Oncologia (IEO)
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 06351
        • Clinical Trial Pharmacy, Samsung Medical Center
      • Seoul, Korea, Republic of, 06229
        • Gangnam Severance Hospital
      • Moscow, Russian Federation, 121309
        • Limited Liability Company "VitaMed" (LLC "VitaMed")
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
      • Singapore, Singapore, 188770
        • Raffles Hospital
      • Singapore, Singapore, 169608
        • Singhealth Investigational Medicine Unit
      • Singapore, Singapore, 188770
        • Raffles Radiology
      • Singapore, Singapore, 169608
        • Department of Nuclear Medicine and Molecular Imaging
      • Singapore, Singapore, 169856
        • Department of Pathology
      • Singapore, Singapore, 217562
        • Farrer Park Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei, Taiwan, 112
        • Department of Radiology, Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei, Taiwan, 112
        • Division of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center
    • Arizona
      • 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 - HAL
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates, PC - HOPE
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates, PC - HOPE
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Solvang, California, United States, 93463
        • Sansum Clinic
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale-New Haven
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center - EPC
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center, Department of Obstetrics and Gynecology and Women's Health
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center-Centennial Facility
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital, Gynecologic Oncology
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital, Infusion Center
      • Mineola, New York, United States, 11501
        • NYU Winthrop Radiology
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
      • Cincinnati, Ohio, United States, 45211
        • Oncology Hematology Care, Inc.
      • Cincinnati, Ohio, United States, 45230
        • Oncology Hematology Care Inc
      • Cincinnati, Ohio, United States, 45236
        • Oncology Hematology Care Inc
    • Oregon
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists, P.C.
      • Portland, Oregon, United States, 97213-2982
        • Northwest Cancer Specialists, P.C.
      • Portland, Oregon, United States, 97225
        • Northwest Cancer Specialists, P.C.
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists, P.C.
    • Tennessee
      • 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
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
      • 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
        • Tennessee Oncology, PLLC
    • Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology Bedford
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology
      • Irving, Texas, United States, 75063
        • US Oncology Investigational Products Center
      • Irving, Texas, United States, 75063
        • US Oncology Investigational Products Center (IPC)
      • San Antonio, Texas, United States, 78240
        • Texas Oncology- San Antonio
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer including carcinosarcoma with high-grade serous component.
  • Patients must be candidates for bevacizumab in combination with platinum based chemotherapy and previously untreated.
  • Must have completed a primary surgical debulking procedure, or be candidates for neoadjuvant chemotherapy with planned interval debulking surgery.

    1. Patients who completed primary debulking must have had incompletely resected disease that is macroscopically/grossly visible and at least with lesions >1 mm and be randomized at a maximum of 8 weeks after surgery.
    2. For patients who are candidates for neoadjuvant chemotherapy, the diagnoses must have been confirmed by:

      • Core tissue (not fine-needle aspiration) biopsy is required for diagnosis.
      • Stage IIIC-IV documented via imaging or surgery (without attempt at cytoreduction).
      • Serum CA-125/CEA ratio >25. If the serum CA-125/CEA ratio is <25, then workup should be negative for the presence of a primary gastrointestinal or breast malignancy (<6 weeks before start of neoadjuvant treatment).
      • Randomization must occur within 8 weeks after diagnosis.
  • Availability of an archival FFPE tumor tissue block or a minimum of 25 slides, together with an accompanying original H&E slide. If archived FFPE tissue is not available, a de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies. Tumor tissue must contain 40% or greater tumor nuclei per central laboratory assessment.
  • ECOG performance status 0-1
  • Age >=18 years (or >=20 years in Japan).
  • Adequate bone marrow, hepatic, and renal function and blood coagulation

Exclusion Criteria:

  • Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.
  • Patients for whom intraperitoneal cytotoxic chemotherapy is planned.
  • Prior exposure to immunotherapy with interleukin (IL)-2, interferon alpha (IFN-α), or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (anti-CTLA4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, excluding therapeutic anticancer vaccines.
  • Prior treatment with a PARP inhibitor.
  • Prior treatment with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab.
  • Major surgery (other than debulking or exploratory surgery for ovarian cancer) for any reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.
  • Prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Prior targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary or fallopian tube carcinoma.
  • Prior organ transplantation including allogenic stem cell transplantation.
  • Diagnosis of Myelodysplastic Syndrome (MDS).
  • 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 enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chemotherapy, avelumab and talazoparib
Platinum-based chemotherapy + avelumab followed by avelumab + talazoparib maintenance

Chemotherapy Period Paclitaxel Carboplatin Avelumab

Maintenance Period Avelumab Talazoparib

Experimental: chemotherapy, and talazoparib
Platinum-based 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

Chemotherapy Period Paclitaxel Carboplatin Bevacizumab

Maintenance Period Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+)
Time Frame: At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy
Progression-free survival (PFS) was defined as the time from randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD.
At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (On-Treatment Period)
Time Frame: From the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day (maximum up to 3.5 years approximately)

An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was lifethreatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event. AEs included SAEs and non-serious AEs.

On-treatment period was defined as the time from the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day.

From the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day (maximum up to 3.5 years approximately)
Number of Participants With ADA Against Avelumab by Never and Ever Positive Status
Time Frame: Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months.
Predose Anti-drug antibodies (ADA) samples were collected within 2 hours prior to avelumab dosing and drawn from the contralateral arm of the avelumab infusion.
Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months.
Pre-dose/Trough Concentration (Ctrough) for Avelumab (Chemotherapy Period)
Time Frame: Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks)
Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data
Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks)
Pre-dose/Trough Concentration (Ctrough) for Avelumab (Maintenance Period)
Time Frame: Pre-dose on Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period (1 cycle = 6 weeks) and at the end of treatment, up to 27 months.
Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data
Pre-dose on Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period (1 cycle = 6 weeks) and at the end of treatment, up to 27 months.
Cmax for Avelumab (Chemotherapy Period)
Time Frame: Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks)
Cmax was defined as maximum observed plasma concentration and it was observed directly from data
Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks)
Cmax for Avelumab (Maintenance Period)
Time Frame: Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months.
Cmax was defined as maximum observed plasma concentration and it was observed directly from data
Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months.
Ctrough for Talazoprib (Maintenance Period)
Time Frame: Pre-dose on Days 1, 15 and 29 of Cycle 1
Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data.
Pre-dose on Days 1, 15 and 29 of Cycle 1
Overall Survival (Participants of Both DDR+ and Unselected DDR Status)
Time Frame: From 9 weeks up to approximately 3.5 years
OS was defined as the time from the date of randomization to the date of death due to any cause.
From 9 weeks up to approximately 3.5 years
Progression-free Survival (Participants of Unselected DDR Status)
Time Frame: At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years.
PFS was defined as the time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occured first.
At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years.
Progression-free Survival (Participants of Both DDR+ and Unselected DDR Status)
Time Frame: At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years.
PFS was defined as the time from randomization to the date of the first documentation of objective progressive disease(PD) or death due to any cause, whichever occured first. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method.
At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years.
Progression-free Survival on Next-line Therapy. (Participants of Both DDR+ and Unselected DDR Status)
Time Frame: From screening until the participant had objective PD on or prior to start of next-line anti-cancer treatment, and started a second subsequent anti-cancer treatment or the participant died, up to approximately 3.5 years.
Progression-free survival on next-line therapy (PFS2) was defined as time from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occured first. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method
From screening until the participant had objective PD on or prior to start of next-line anti-cancer treatment, and started a second subsequent anti-cancer treatment or the participant died, up to approximately 3.5 years.
PFS Per Gynecological Cancer Intergroup Criteria (Participants of Both DDR+ and Unselected DDR Status)
Time Frame: From screening until death, end of study, or participant withdrawal of consent, whichever occurred first, up to approximately 3.5 years.
PFS based on investigator assessment per Gynecological Cancer Intergroup criteria (GCIG) would be assessed incorporating both Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and CA 125. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method.
From screening until death, end of study, or participant withdrawal of consent, whichever occurred first, up to approximately 3.5 years.
Functional Assessment of Ovarian Symptom Index-18 (FOSI-18) Score
Time Frame: 3 years

NFOSI-18 was an ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. It was specifically designed to be a stand-alone instrument to measure disease-related symptoms, treatment side effects and function/well-being in participants with ovarian cancer.

The NFOSI-18 has several subscales: disease-related symptoms physical subscale(9 items), disease-related symptoms emotional subscale(1 item), treatment-related side effect subscale (5 items) and functional well-being (3 items). A high score was good. A score of "0" was a severely symptomatic participant and the highest possible score was an asymptomatic participant.

3 years
Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline
Time Frame: Baseline
The number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest that were defined by tumor cell morphology and the presence or absence of inflammatory cells
Baseline
Number of Participants With Mutations in Key Oncogenes at Baseline
Time Frame: Baseline
Determination/estimation of the frequency of mutations (total and non-synonymous) present in baseline tumor derived nucleic acid samples and in baseline circulating tumor DNA.
Baseline
EuroQol Group 5-Dimension 5-Level (EQ-5D-5L) Score
Time Frame: 3 years
The EuroQol EQ-5D-5L was a 6 item participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights were available that allow for imputation of the index score. Overall index scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2018

Primary Completion (Actual)

December 22, 2021

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on Chemotherapy + avelumab followed by avelumab + talazoparib

Subscribe