Clinical Trial Details

NCT ID: NCT02340975
Date Last Changed: September 26, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using MEDI4736 + Tremelimumab, MEDI4736 and Tremelimumab for patients with Gastric or Gastroesophageal Junction Adenocarcinoma

Research Study Title

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

Purpose

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

To Learn more

Recruitment Details

Phase
1/2
Gender
All
Age
18 to 99 Years
Overall Status
Recruiting
Lead Sponsor
MedImmune LLC
Duration
42 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 99 Years

Inclusion Criteria:

  1. Male and female subjects

  2. 18 years and older

  3. Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma

  4. Subjects must have received and have progressed, or are refractory to standard regimens

  5. Subjects must have at least one lesion amenable to biospy

Exclusion Criteria:

  1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment

  2. Previous immunotherapy

  3. Concurrent or prior use of immunosuppressive medication with 14 days

  4. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions

Site Locations (29)

Country State City Zip Facility and Contact
United States California Los Angeles 90033 Research Site
United States California Santa Monica 90404 Research Site
United States Connecticut New Haven 06520 Research Site
United States Florida Tampa 33612 Research Site
United States Illinois Chicago 60611 Research Site
United States Illinois Chicago 60637 Research Site
United States Maryland Baltimore 21287 Research Site
United States New York New York 10016 Research Site
United States New York New York 10032 Research Site
United States New York New York 10065 Research Site
United States Ohio Cleveland 44106 Research Site
United States Oregon Portland 97213 Research Site
United States Pennsylvania Philadelphia 19111 Research Site
United States South Carolina Greenville 29605 Research Site
United States Tennessee Nashville 37203 Research Site
United States Texas Houston 77030 Research Site
Canada Ontario Toronto M5G 2M9 Research Site
Canada Quebec Montreal H4A 3J1 Research Site
Japan Kawasaki-shi 216-8511 Research Site
Japan Koto-ku 135-8550 Research Site
Japan Osaka-shi 541-8567 Research Site
Korea, Republic of Seongnam-si 13620 Research Site
Korea, Republic of Seoul 03080 Research Site
Korea, Republic of Seoul 03722 Research Site
Korea, Republic of Seoul 06351 Research Site
Singapore Singapore 119074 Research Site
Singapore Singapore 308433 Research Site
Taiwan Taipei 100 Research Site
Taiwan Tao-Yuan 333 Research Site

Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
E-mail:

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