A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MedImmune LLC
Study ID
NCT02205333
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumors
  • Aggressive B-cell Lymphomas

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736 (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469 in a set of participants with advanced solid tumors while rituximab will be tested with MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants with advanced solid tumors.

Key Dates

Start date
Aug 13, 2014
Status verified
Jun 2017
Primary completion
Apr 8, 2016
Completion
Apr 8, 2016

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI6469 6 mg/kg
    Participants received MEDI6469 6 milligram/kilogram (mg/kg) as a single intravenous (IV) administration on Day 1
  • Experimental: MEDI6469 10 mg/kg
    Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
  • Experimental: 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
  • Experimental: 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)
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of MEDI6469 [ Time Frame: From the first dose of study treatment through 28 days after the first dose (up to 28 days) ]

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85259-
Research SiteSacramentoCalifornia95817-
Research SiteSanta MonicaCalifornia90404-
Research SiteWashington D.C.District of Columbia20007-
Research SiteTampaFlorida33612-
Research SiteChicagoIllinois60611-
Research SiteDetroitMichigan48202-
Research SiteLas VegasNevada89169-
Research SiteHackensackNew Jersey7601-
Research SiteHuntersvilleNorth Carolina28078-
Research SitePortlandOregon97213-
Research SiteMemphisTennessee38120-
Research SiteHoustonTexas77030-

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