Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

Layout table for study information
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

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


  Show 28 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Layout table for investigator information
Study Director: MedImmune, LLC MedImmune, LLC MedImmune LLC

Layout table for additonal information
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:
Layout table for 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
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs