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Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Last updated on December 9, 2019

FOR MORE INFORMATION
Study Location
Alabama Oncology
Alabaster, Alabama, 35007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary
peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous
component

- Patients must be candidates for platinum based chemotherapy and previously untreated

- Patients must have completed a surgical debulking procedure, or be candidates for
neoadjuvant chemotherapy

- Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue
block or a minimum of 15 slides

- ECOG PS 0-1

- Adequate hematological, renal, and liver function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline
tumors) or mucinous tumors

- Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior
immunotherapy with IL 2, IFN ?, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or
anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including
ipilimumab), or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways

- Patients for whom, in the opinion of the Investigator, there is clinical benefit to
administer bevacizumab as a first-line treatment and for whom bevacizumab is approved
and available in this setting.

- Cancer for which intraperitoneal cytotoxic chemotherapy is planned

- Active autoimmune disease (some exceptions include diabetes type I, vitiligo,
psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)

NCT02718417
Pfizer
Terminated
Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

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Descriptive Information
Brief Title  ICMJE Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
Official Title  ICMJE A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN CANCER JAVELIN OVARIAN 100
Brief Summary

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.

The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: carboplatin
    Given Q3W during chemotherapy phase
  • Drug: paclitaxel
    Investigator choice of weekly or Q3W during chemotherapy phase
  • Drug: Avelumab
    Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion
  • Drug: Avelumab
    Given as single agent in maintenance portion Q2W
Study Arms  ICMJE
  • Active Comparator: Arm A
    Chemotherapy followed by observation
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: Arm B
    Chemotherapy followed by avelumab in maintenance
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Avelumab
  • Experimental: Arm C
    Chemotherapy in combination with avelumab followed by avelumab in maintenance
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Avelumab
    • Drug: Avelumab
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
998
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
951
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion DateSeptember 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
  • Patients must be candidates for platinum based chemotherapy and previously untreated
  • Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
  • Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
  • ECOG PS 0-1
  • Adequate hematological, renal, and liver function

Key Exclusion Criteria:

  • Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
  • Prior systemic anti-cancer treatment for EOC, FTC, or PPC including prior immunotherapy with IL 2, IFN ?, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
  • Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
  • Cancer for which intraperitoneal cytotoxic chemotherapy is planned
  • Active autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Croatia,   Estonia,   Germany,   Hong Kong,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718417
Other Study ID Numbers  ICMJE B9991010
2015-003239-36 ( EudraCT Number )
JAVELIN OVARIAN 100 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Study Chair:Bradley Monk, MDDepartment of Obstetrics and Gynecology University of Arizona Cancer Center, USA
Study Chair:Jonathan Ledermann, MDUCL Cancer Institute, UK
PRS AccountPfizer
Verification DateJuly 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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