A Phase 1b/2 Study of MEDI4736 with Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
Study identifier:D4190C00021
ClinicalTrials.gov identifier:NCT02340975
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Gastric or Gastroesophageal Junction Adenocarcinoma
Phase
Phase 1/2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
114
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 31 Mar 2015
Primary Completion Date: 29 Apr 2019
Study Completion Date: 29 Apr 2019
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase 1b-M20 mg/kg (Q4W) + T 1 mg/kg (Q4W) Fw M10 mg/kg (Q2W) Participants in second-line therapy with gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive intravenous (IV) infusion of 20 mg/kg MEDI4736 every 4 weeks (Q4W) for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 + tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab. |
| Experimental: Phase 2 Arm A-(M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W) Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 + tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab. |
| Experimental: Phase 2 Arm B-M10 mg/kg (Q2W) Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg MEDI4736 Q2W for 12 months (up to 26 doses). | Biological/Vaccine: MEDI4736 MEDI4736 will be administered by IV infusion. |
| Experimental: Phase 2 Arm C-T10 mg/kg (Q4W) Participants in second-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 10 mg/kg tremelimumab Q4W for 7 doses and then Q12W for 2 doses for 12 months (for a total of up to 9 doses). | Biological/Vaccine: Tremelimumab Tremelimumab will be administered by IV infusion. |
| Experimental: Phase 2 Arm D-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W) Participants in third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736+tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab. |
| Experimental: Phase 2 Arm E-M20 mg/kg (Q4W) + T1 mg/kg Fw M10 mg/kg (Q2W) Participants in second and third-line therapy with metastatic or recurrent gastric or GEJ adenocarcinoma and a positive IFN-γ gene expression signature will receive IV infusion of 20 mg/kg MEDI4736 Q4W for 4 months (up to 4 doses) in combination with IV 1 mg/kg tremelimumab Q4W for 4 months (up to 4 doses in total). Thereafter, participants will receive MEDI4736 monotherapy (10 mg/kg) every 2 weeks (Q2W) to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 + tremelimumab MEDI4736 will be administered by IV infusion in combination with tremelimumab. |
Contacts
Investigators
Principal Investigator
MedImmune, LLC MedImmune, LLC
MedImmune LLC
