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Trial record 1 of 1 for:    NCT02718417
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Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02718417
First received: March 15, 2016
Last updated: June 29, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer Drug: carboplatin Drug: paclitaxel Drug: Avelumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline to measured progressive disease (up to 36 months) ]

    The period from study entry until disease progression, death or date of last contact.

    Assessments to be completed by third-party blinded independent committee review.



Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 112 months) ]
    Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

  • Maintenance Progression-Free Survival (PFS) [ Time Frame: Maintenance baseline to date of measured progressive disease (up to 24 months) ]
    Maintenance PFS is defined, for patients who proceed to maintenance and who do not have PD by BICR during the chemotherapy phase, as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first

  • Duration of Response (DR) [ Time Frame: Baseline up to 36 months ]
    Time in weeks/months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause, whichever occurs first.

  • Objective Response Rate - Percentage of Participants With Objective Response [ Time Frame: Baseline up to 36 months ]

    Objective response is defined as a complete response (CR) or partial response (PR) per 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. A patient will be considered to have achieved an OR if the patient has a sustained complete response (CR) or partial response (PR) according to RECIST v.1.1 definitions. Otherwise, the patient will be considered as a non responder in the OR rate (ORR) analysis.

    The ORR on each treatment arm will be estimated by dividing the number of patients with OR (CR or PR) by the number of patients randomized to the respective treatment arm.


  • EuroQoL5 Dimension (EQ-5D-5L) [ Time Frame: Baseline, every 6 weeks, through study completion (up to 2 years), and follow-up (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 individuals rate their level of problems (none, slight, moderate, severe, or extreme/unable) in 5 areas (mobility, self care, usual activities, pain/discomfort, and anxiety/depression).

  • FOSI-18 [FACT Ovarian Symptom Index-18] [ Time Frame: Baseline, every 6 weeks, through study completion (up to 2 years), and follow-up (up to 3 years) ]
    The FOSI 18 (a revised, more symptom focused version of the FACT O) was developed to be part of the Functional Assessment of Chronic Illness Therapy (FACIT) system and was specifically created with the input from the Food and Drug Administration (FDA) and validated in ovarian cancer patients.designed to be a stand alone instrument to measure disease symptoms, treatment side effects and function/well being in patients with ovarian cancer.

  • ADA [Anti-Drug Antibodies] [ Time Frame: Screening, Day 1 of Chemo cycles 1-4, Day 1 and 15 of Maintenance cycles 1 and 2, up to 30 days post follow-up ]
    The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.

  • Presence or absence of predictive candidate biomarkers in tumor tissue [ Time Frame: Baseline ]
    To identify predictive biomarkers of sensitivity or resistance in pre-treatment tissue (PD-L1 expression tumor infiltrating CD8+ T cells, etc....)

  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 1, 3 4, 5, 6, 10, 24 hr post-paclitaxel on D1 of C2; pre-dose, 0.25, 0.5, 1, 5, 6, 10, 24 hrs post-carboplatin infusion on D1 of C2; 2 hrs prior to and immediately before the end of avelumab infusion on D1 of C1-C4. ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Cmax [ Time Frame: 1, 3 4, 5, 6, 10, 24 hr post-paclitaxel on D1 of C2; pre-dose, 0.25, 0.5, 1, 5, 6, 10, 24 hrs post-carboplatin infusion on D1 of C2; 2 hrs prior to and immediately before the end of avelumab infusion on D1 of C1-C4. ]
    Maximum Observed Plasma Concentration (Cmax)

  • Volume of Distribution [ Time Frame: 1, 3 4, 5, 6, 10, 24 hr post-paclitaxel on D1 of C2; pre-dose, 0.25, 0.5, 1, 5, 6, 10, 24 hrs post-carboplatin infusion on D1 of C2; 2 hrs prior to and immediately before the end of avelumab infusion on D1 of C1-C4. ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  • Clearance (CL) [ Time Frame: 1, 3 4, 5, 6, 10, 24 hr post-paclitaxel on D1 of C2; pre-dose, 0.25, 0.5, 1, 5, 6, 10, 24 hrs post-carboplatin infusion on D1 of C2; 2 hrs prior to and immediately before the end of avelumab infusion on D1 of C1-C4. ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  • Progression Free Survival 2 (PFS2) [ Time Frame: Baseline up to second progression up to 3 years ]
    PFS2 is defined as time from randomization to the start of second subsequent treatment after first progression, or death from any cause, whichever occurs first.

  • pathological Complete response (pCR) [ Time Frame: Baseline to 9 weeks (after IDS) ]
    pCR is defined for neoadjuvant patients who undergo interval debulking surgery and assessed for pathological response


Estimated Enrollment: 951
Actual Study Start Date: May 19, 2016
Estimated Study Completion Date: December 5, 2021
Estimated Primary Completion Date: September 6, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Chemotherapy followed by observation
Drug: carboplatin
Given Q3W during chemotherapy phase
Drug: paclitaxel
Investigator choice of weekly or Q3W during chemotherapy phase
Experimental: Arm B
Chemotherapy followed by avelumab in maintenance
Drug: carboplatin
Given Q3W during chemotherapy phase
Drug: paclitaxel
Investigator choice of weekly or Q3W during chemotherapy phase
Drug: Avelumab
Given as single agent in maintenance portion Q2W
Experimental: Arm C
Chemotherapy in combination with avelumab followed by avelumab in maintenance
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 α, 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02718417

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 320 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Chair: Bradley Monk, MD Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA
Study Chair: Jonathan Ledermann, MD UCL Cancer Institute, UK
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02718417     History of Changes
Other Study ID Numbers: B9991010
2015-003239-36 ( EudraCT Number )
JAVELIN OVARIAN 100 ( Other Identifier: Alias Study Number )
Study First Received: March 15, 2016
Last Updated: June 29, 2017

Keywords provided by Pfizer:
untreated epithelial ovarian
fallopian tube
primary peritoneal cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017