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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
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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Brief 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 subjects with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
  3. Phase 2: Objective Response Rate [ Time Frame: Followed through 5 years after the last subject receives the first dose of study medication ]
  4. 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 ]

Secondary Outcome Measures :
  1. Phase 1: Objective Response Rate [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  2. 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 ]
  3. Disease Control Rate [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  4. PD-L1 expression [ Time Frame: Follow up through 3 months after last dose of study medication ]
  5. Overall Survival [ Time Frame: Follow up through 5 years after the last subjects receives the first dose of study medication ]
  6. Duration of Response [ Time Frame: Follow up through 5 years after the last subject receives the first dose of study medication ]
  7. 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 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


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Locations
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
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: MedImmune, LLC MedImmune, LLC MedImmune LLC
More Information
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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