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Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction

NCT02625610•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female participants greater than or equal to (\>=) 18 years
•Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
•Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
•Estimated life expectancy of more than 12 weeks
•Adequate haematological, hepatic and renal functions defined by the protocol
•Negative blood pregnancy test at Screening for women of childbearing potential
•Highly effective contraception for both male and female participants if the risk of conception exists

Exclusion Criteria

•Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
•Concurrent anticancer treatment or immunosuppressive agents
•Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
•Tumor shown to be human epidermal growth factor 2 plus (HER2+)
•Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment
•Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to \<= 10 mg prednisone daily)
•All participants with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
•Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)
•Prior organ transplantation, including allogeneic stem-cell transplantation
•Significant acute or chronic infections
+13 more criteria

Locations (200)

Comprehensive Blood & Cancer Center

Bakersfield, California, United States

Virginia Crosson Cancer Center

Fullerton, California, United States

UCLA Medical Center

Los Angeles, California, United States

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, United States

Sansum Clinic

Santa Barbara, California, United States

Trio - Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Norwalk Hospital

Norwalk, Connecticut, United States

UF Health Cancer Center Orlando

Orlando, Florida, United States

Memorial West Cancer Institute

Pembroke Pines, Florida, United States

University of South Florida - Parent

Tampa, Florida, United States

Key Dates

Start Date

December 24, 2015

Primary Completion Date

September 13, 2019

Completion Date

June 3, 2021

Last Updated

June 9, 2022

Enrollment

499

ACTUAL participants

Conditions

Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

Interventions

Avelumab

DRUG

Oxaliplatin

DRUG

5-Fluorouracil

DRUG

Leucovorin

DRUG

Capecitabine

DRUG

Best supportive care

OTHER

Oxaliplatin

DRUG

5-Fluorouracil

DRUG

Leucovorin

DRUG

Capecitabine

DRUG