D4190C00021: A Phase 1b/2 Study of MEDI4736 in Combination with Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects with Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

Protocol: 
AAAO8258
Phase: 
I/II

D4190C00021: A Phase 1b/2 Study of MEDI4736 in Combination with Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects with Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

This study is being conucted in participants with gastric (stomach) cancer or cancer of the gastroesophageal junction (where the esophagus meets the stomach) that has returned after treatment (recurrent), or has spread to another area of your body (metastatic). This study will occur in two parts, Phase 1b (Part 1) and Phase 2 (Part 2). The main purpose of Part 1 is to determine the doses and dosing schedule of both MEDI4736 and tremelimumab that are safe and tolerable when given together in subjects with gastric (stomach) cancer or cancer of the gastroesophageal junction (where the esophagus meets the stomach). Part 2 of the study will begin when the Sponsor determines the safe and tolerable doses and dosing schedule from Part 1. The main purpose of Part 2 is to continue to assess the safety and tolerability of the MEDI4736 and tremelimumab doses and dosing schedule determined by the Sponsor during Part 1, and to assess the safety and tolerability of both MEDI4736 and tremelimumab when administered alone. In Part 2 of this study, adult subjects with metastatic or recurrent gastric cancer or cancer of the gastroesophageal junction will be randomly enrolled into 1 of 4 treatment cohorts (groups) based on previously received treatments for their cancer.

Are you Eligible? (Inclusion Criteria)

1. Patients must have a Gastric or Gastroesophageal Junction Adenocarcinoma
that continues to get worse or return despite standard therapy.

2. Patients must be in good physical shape. This means that patients must be
able to walk, care for themselves, and do light physical activities such as
light housework or office work.

3. This study is for patients age 18 or older

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States