A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT02340975 |
Recruitment Status :
Active, not recruiting
First Posted : January 19, 2015
Last Update Posted : February 11, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric or Gastroesophageal Junction Adenocarcinoma | Biological: MEDI4736 + tremelimumab Biological: MEDI4736 Biological: Tremelimumab Biological: MEDI4736+tremelimumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | March 31, 2015 |
Estimated Primary Completion Date : | April 18, 2019 |
Estimated Study Completion Date : | April 18, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: MEDI4736 + tremelimumab (Arm A)
Second line subjects with metastatic or recurrent gastric or GEJ adenocarcinoma
|
Biological: MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab. |
Experimental: MEDI4736 (Arm B)
Second line subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
|
Biological: MEDI4736
MEDI4736 will be administered by IV infusion. |
Experimental: Tremelimumab (Arm C)
Second line subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
|
Biological: Tremelimumab
Tremelimumab will be administered by IV infusion. |
Experimental: MEDI4736 + tremelimumab (Arm D)
Third line subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
|
Biological: MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab |
Experimental: MEDI4736 + tremelimumab (Arm E)
Second or third line biomarker-selected subjects with metastatic or recurrent Gastric or GEJ adenocarcinoma
|
Biological: MEDI4736+tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab |
- Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events. [ Time Frame: Follow-up 90 days after the last dose of study medication ]
- Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
- Phase 2: Objective Response Rate [ Time Frame: Followed through 5 years after the last subject receives the first dose of study medication ]
- Phase 2: Progression Free Survival at 6 months [ Time Frame: Followed through 5 years after the last subject receives the first dose of study medication ]
- Phase 1: Objective Response Rate [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
- Phase 1: Progression Free Survival at 6 months [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
- Disease Control Rate [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
- PD-L1 expression [ Time Frame: Follow up through 3 months after last dose of study medication ]
- Overall Survival [ Time Frame: Follow up through 5 years after the last subjects receives the first dose of study medication ]
- Duration of Response [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
- Phase 2: Number (percentage) of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events. [ Time Frame: Follow-up 90 days after the last dose of study medication ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion 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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340975

United States, California | |
Research Site | |
Los Angeles, California, United States, 90033 | |
Research Site | |
Santa Monica, California, United States, 90404 | |
United States, Connecticut | |
Research Site | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
Research Site | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Research Site | |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
Research Site | |
Baltimore, Maryland, United States, 21231 | |
United States, New York | |
Research Site | |
New York, New York, United States, 10032 | |
Research Site | |
New York, New York, United States, 10065 | |
Research Site | |
New York, New York, United States, 10116 | |
United States, Ohio | |
Research Site | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Research Site | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, South Carolina | |
Research Site | |
Greenville, South Carolina, United States, 29605 | |
United States, Tennessee | |
Research Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Research Site | |
Houston, Texas, United States, 77030 | |
Canada, Quebec | |
Research Site | |
Montreal, Quebec, Canada, H4A 3J1 | |
Japan | |
Research Site | |
Kawasaki-shi, Japan, 216-8511 | |
Research Site | |
Koto-ku, Japan, 135-8550 | |
Research Site | |
Osaka-shi, Japan, 541-8567 | |
Korea, Republic of | |
Research Site | |
Seongnam-si, Korea, Republic of, 13620 | |
Research Site | |
Seoul, Korea, Republic of, 03080 | |
Research Site | |
Seoul, Korea, Republic of, 03722 | |
Research Site | |
Seoul, Korea, Republic of, 06351 | |
Singapore | |
Research Site | |
Singapore, Singapore, 119082 | |
Research Site | |
Singapore, Singapore, 308433 | |
Taiwan | |
Research Site | |
Taipei, Taiwan, 100 | |
Research Site | |
Taipei, Taiwan, 11217 | |
Research Site | |
Taoyuan, Taiwan, 333 |
Study Director: | MedImmune, LLC MedImmune, LLC | MedImmune LLC |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT02340975 History of Changes |
Other Study ID Numbers: |
D4190C00021 |
First Posted: | January 19, 2015 Key Record Dates |
Last Update Posted: | February 11, 2019 |
Last Verified: | February 2019 |
Keywords provided by MedImmune LLC:
Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Immunotherapy |
Antibodies, Monoclonal Tremelimumab MEDI4736 |
Additional relevant MeSH terms:
Adenocarcinoma Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Antibodies, Monoclonal Tremelimumab Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |