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3G-15-2: 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

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 subjects 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 subjects
  • 18 years and older
  • Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
  • Subjects must have received and have progressed, or are refractory to standard regimens
  • Subjects 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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