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
Description
Brief Summary
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.
Phase
Phase 1/2 - for trials that are a combination of phases 1 and 2.Inclusion and Exclusion Criteria
- 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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