Esophageal Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion 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

Exclusion Criteria:

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT02340975

Recruitment Status:

Completed

Sponsor:

MedImmune LLC

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There are 28 Locations for this study

See Locations Near You

Research Site
Los Angeles California, 90033, United States
Research Site
Santa Monica California, 90404, United States
Research Site
New Haven Connecticut, 06520, United States
Research Site
Tampa Florida, 33612, United States
Research Site
Chicago Illinois, 60637, United States
Research Site
Baltimore Maryland, 21231, United States
Research Site
New York New York, 10032, United States
Research Site
New York New York, 10065, United States
Research Site
New York New York, 10116, United States
Research Site
Cleveland Ohio, 44106, United States
Research Site
Portland Oregon, 97213, United States
Research Site
Philadelphia Pennsylvania, 19111, United States
Research Site
Greenville South Carolina, 29605, United States
Research Site
Nashville Tennessee, 37203, United States
Research Site
Houston Texas, 77030, United States
Research Site
Montreal Quebec, H4A 3, Canada
Research Site
Kawasaki-shi , 216-8, Japan
Research Site
Koto-ku , 135-8, Japan
Research Site
Osaka-shi , 541-8, Japan
Research Site
Seongnam-si , 13620, Korea, Republic of
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Singapore , 11908, Singapore
Research Site
Singapore , 30843, Singapore
Research Site
Taipei , 100, Taiwan
Research Site
Taipei , 11217, Taiwan
Research Site
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT02340975

Recruitment Status:

Completed

Sponsor:


MedImmune LLC

How clear is this clinincal trial information?

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