NCT02340975

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	MEDI4736 + tremelimumab	MEDI4736 will be administered by IV infusion in combination with tremelimumab.
BIOLOGICAL	MEDI4736 + tremelimumab	MEDI4736 will be administered by IV infusion in combination with tremelimumab.
BIOLOGICAL	MEDI4736	MEDI4736 will be administered by IV infusion.
BIOLOGICAL	Tremelimumab	Tremelimumab will be administered by IV infusion.
BIOLOGICAL	MEDI4736+tremelimumab	MEDI4736 will be administered by IV infusion in combination with tremelimumab.
BIOLOGICAL	MEDI4736 + tremelimumab	MEDI4736 will be administered by IV infusion in combination with tremelimumab.

Timeline

• Start date: 2015-03-31
• Primary completion: 2019-04-29
• Completion: 2019-04-29
• First posted: 2015-01-19
• Last updated: 2020-06-09
• Results posted: 2020-05-11

Locations

28 sites across 6 countries: United States, Canada, Japan, Singapore, South Korea, Taiwan