A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma

Completed · Phase 1/Phase 2

Conditions studied: Gastric or Gastroesophageal Junction Adenocarcinoma

In brief

This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.

Key facts

Study ID

NCT02340975

Run by

MedImmune LLC

People needed

114

Starts

2015-03-31

Expected to finish

2019-04-29

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants
• 18 years and older
• Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
• Participants must have received and have progressed, or are refractory to standard regimens
• Participants must have at least one lesion amenable to biospy

You may not qualify if…

• Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
• Previous immunotherapy
• Concurrent or prior use of immunosuppressive medication with 14 days
• Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Tampa, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Montreal, Quebec, Canada
• Research Site — Kawasaki-shi, Japan
• Research Site — Kōtoku, Japan
• Research Site — Osaka, Japan
• Research Site — Singapore, Singapore
• Research Site — Singapore, Singapore
• Research Site — Seongnam-si, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.