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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Greenville, SC, United States, 29605

Location

Research Site

Tampa, FL, United States, 33612

Location

Research Site

Portland, OR, United States, 97213

Location

Research Site

Nashville, TN, United States, 37203

Location

Research Site

New York, NY, United States, 10032

Location

Research Site

Cleveland, OH, United States, 44106

Location

Research Site

Chicago, IL, United States, 60637

Location

Research Site

Santa Monica, CA, United States, 90404

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.

Documents available

Redacted D4190C00021 SAP v3.0 final
Download
Protocol D4190C00021_Redacted_Final_April2020_Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Study Locator Service

1-877-400-4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

MedImmune, LLC MedImmune, LLC

MedImmune LLC

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Redacted D4190C00021 SAP v3.0 final

Protocol D4190C00021_Redacted_Final_April2020_Redacted

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator