NCT02625610|CompletedPhase 3ResultsDMC

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

EMD Serono Research & Development Institute, Inc.ClinicalTrials.gov

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2 other identifiers

EMR 100070-0072015-003300-23

Study Type

interventional

Target

499

Locations

17 countries

Sites

200

Timeline

RegisteredDec 2015

StartedDec 2015

CompletionJun 2021

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

499

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2015

Longer than P75 for phase_3

Geographic Reach

17 countries

200 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

First Submitted

Initial submission to the registry

December 4, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed

15 days until next milestone

Study Start

First participant enrolled

December 24, 2015

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2021

Completed

5 months until next milestone

Results Posted

Study results publicly available

November 4, 2021

Completed

Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

December 4, 2015

Results QC Date

September 30, 2021

Last Update Submit

May 11, 2022

Conditions

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

Keywords

AvelumabCancerUnresectableLocally advancedMetastaticAdenocarcinoma of the stomachGastro-esophageal junction

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.
From randomization into maintenance phase up to 1276 days

Secondary Outcomes (12)

Progression Free Survival (PFS) by Independent Review Committee (IRC)
From randomization into maintenance phase up to 1276 days
Best Overall Response (BOR) by Investigator Assessment
From randomization into maintenance phase up to 1276 days
Objective Response Rate (ORR) by Investigator Assessment
From randomization into maintenance phase up to 1276 days
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks)
Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks)
Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
+7 more secondary outcomes

Study Arms (2)

Chemotherapy + Best Supportive Care (BSC)

EXPERIMENTAL

In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/LV or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.

Drug: OxaliplatinDrug: 5-FluorouracilDrug: LeucovorinDrug: CapecitabineOther: Best supportive care

Avelumab

EXPERIMENTAL

In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation.

Drug: Avelumab

Interventions

AvelumabDRUG

Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.

Also known as: MSB0010718C, Anti PD-L1

Avelumab

OxaliplatinDRUG

Induction Phase: Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.