A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
NCT ID: NCT02340975
Last Updated: 2020-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
114 participants
INTERVENTIONAL
2015-03-31
2019-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
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).
MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
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).
MEDI4736
MEDI4736 will be administered by IV infusion.
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).
Tremelimumab
Tremelimumab will be administered by IV infusion.
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).
MEDI4736+tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
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).
MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Interventions
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MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
MEDI4736
MEDI4736 will be administered by IV infusion.
Tremelimumab
Tremelimumab will be administered by IV infusion.
MEDI4736+tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
MEDI4736 + tremelimumab
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
Eligibility Criteria
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Inclusion Criteria
2. 18 years and older
3. Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
4. Participants must have received and have progressed, or are refractory to standard regimens
5. Participants must have at least one lesion amenable to biospy
Exclusion Criteria
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
18 Years
99 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune, LLC MedImmune, LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Los Angeles, California, United States
Research Site
Santa Monica, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Tampa, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Montreal, Quebec, Canada
Research Site
Kawasaki-shi, , Japan
Research Site
Kōtoku, , Japan
Research Site
Osaka, , Japan
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Redacted D4190C00021 SAP v3.0 final
Protocol D4190C00021\_Redacted\_Final\_April2020\_Redacted
Other Identifiers
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D4190C00021
Identifier Type: -
Identifier Source: org_study_id
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