Open-label trial with avelumab versus first line chemotherapy
Research type
Research Study
Full title
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.
IRAS ID
204531
Contact name
Wasat Mansoor
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2015-003300-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 6 months, 25 days
Research summary
This study is to try and demonstrate superiority of maintenance therapy with avelumab versus continuation of first line chemotherapy. The study includes a screening period, Induction Phase, Maintenance Phase, and Follow-up Phase.
Approximately 666 subjects globally will receive induction chemotherapy comprised of oxaliplatin and either 5-FU or capecitabine (Induction Phase) for 12 weeks. Approximately 466 subjects who experience a complete response (CR), partial response (PR), or stable disease (SD) will enter the Maintenance Phase and be randomised to receive either avelumab, or continuation of the same chemotherapy regimen from the Induction Phase (Maintenance Phase). Participants aged 18 onwards will be eligible
In this trial, treatment with chemotherapy during the Induction Phase will last for 12 weeks, followed by the Maintenance Phase with either avelumab or continuation of the same regimen of chemotherapy from the Induction Phase, which will continue until disease progression or unacceptable toxicity. Subjects receiving avelumab who have experienced a CR should be treated for a minimum of 12 months and/or until disease progression or unacceptable toxicity, after confirmation of response.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0275
Date of REC Opinion
13 Jun 2016
REC opinion
Further Information Favourable Opinion