IRB #

STUDY00015706

Title

EMR100070-007: 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

Principal Investigator

Gina Vaccaro

Study Purpose

To compare the effectiveness of maintenance therapy with avelumab (study drug) compared to continuation of first- line standard of care therapies in adults with unresectable, locally advanced or metastatic adenocarcinoma of the
stomach, or of the gastro-esophageal junction.

Medical Condition(s)

unresectable, locally advanced or metastatic adenocarcinoma of the stomach
unresectable, locally advanced or metastatic adenocarcinoma of the gastro-esophageal junction

Eligibility Criteria

1. Male or female age 18 or older
2. Confirmed unresectable,locally advanced or metastatic, adenocarcinoma of the stomach or the GEJ
3. No prior systemic therapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or GEJ

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Treatment will continue until your disease progresses, you can’t tolerate the treatment, or you and/or your doctor decide to stop treatment. After that participants will be contacted by phone every 12 weeks for 5 years and then annually until the end of the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
knight@ohsu.edu

Sponsor

EMD Serono Research & Development Institute, Inc.

Recruitment End

12/31/2030

Compensation Provided

No


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