A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
NCT ID: NCT02205333
Last Updated: 2017-06-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2014-08-13
2016-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEDI6469 6 mg/kg
Participants received MEDI6469 6 milligram/kilogram (mg/kg) as a single intravenous (IV) administration on Day 1
MEDI6469 Monotherapy
single intravenous (IV) administration of MEDI6469
MEDI6469 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
MEDI6469 Monotherapy
single intravenous (IV) administration of MEDI6469
MEDI6469 2 mg/kg+Tremelimumab 3 mg/k
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1 then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
MEDI6469 Plus Tremelimumab
MEDI6469 in combination with Tremelimumab
MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1 then Q4W for 6 doses after which Q12W for 2 doses or until progression of disease (PD)
MEDI6469 Plus Tremelimumab
MEDI6469 in combination with Tremelimumab
MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1 then every 2 weeks (Q2W) for 12 months or until PD
MEDI6469 Plus Durvalumab
MEDI6469 in combination with Durvalumab
MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
MEDI6469 Plus Durvalumab
MEDI6469 in combination with Durvalumab
MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
MEDI6469 Plus Durvalumab
MEDI6469 in combination with Durvalumab
MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle, or PD plus rituximab 375 mg/m\^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
MEDI6469 plus Rituximab
MEDI6469 in combination with Rituximab
MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
MEDI6469 plus Rituximab
MEDI6469 in combination with Rituximab
Interventions
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MEDI6469 Monotherapy
single intravenous (IV) administration of MEDI6469
MEDI6469 Plus Tremelimumab
MEDI6469 in combination with Tremelimumab
MEDI6469 Plus Durvalumab
MEDI6469 in combination with Durvalumab
MEDI6469 plus Rituximab
MEDI6469 in combination with Rituximab
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exists (Monotherapy and in Cohorts A and B)
* At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in Cohorts A and B)
* Histologically confirmed DLBCL(Cohort C)
* Adequate organ and marrow function
* ECOG performance status of 0 or 1
* Willingness to provide consent for biopsy samples
Exclusion Criteria
* History of organ transplant that requires use of immunosuppressives
* History of primary immunodeficiency or tuberculosis
* Active or prior documented autoimmune disease within the past 3 years
* Active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months
* Major surgical procedure within 30 days prior to the first dose of investigational product or still recovering from prior surgery
* Women who are pregnant or lactating
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
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Scottsdale, Arizona, United States
Research Site
Sacramento, California, United States
Research Site
Santa Monica, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Tampa, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Detroit, Michigan, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Hackensack, New Jersey, United States
Research Site
Huntersville, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Memphis, Tennessee, United States
Research Site
Houston, Texas, United States
Countries
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Other Identifiers
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D4981C00001
Identifier Type: -
Identifier Source: org_study_id
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