A Phase 1b/2 Safety and Tolerability study of MEDI6469 in Combination with Therapeutic Immune Agents or Monoclonal Antibodies - MEDI6469
Study identifier:D4981C00001
ClinicalTrials.gov identifier:NCT02205333
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase 1b/2, Open-label Study to Evaluate the Safety and Tolerability of MEDI6469 in Combination with Immune Therapeutic Agents or Therapeutic Monoclonal Antibodies in Subjects with Selected Advanced Solid Tumors or Aggressive B-cell Lymphomas
Medical condition
Advanced Solid Tumors
Phase
Phase 1/2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 13 Aug 2014
Primary Completion Date: 08 Apr 2016
Study Completion Date: 08 Apr 2016
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2017 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI6469 6 mg/kg Participants received MEDI6469 6 milligram/kilogram (mg/kg) as a single intravenous (IV) administration on Day 1 | Biological/Vaccine: MEDI6469 Monotherapy single intravenous (IV) administration of MEDI6469 |
| Experimental: MEDI6469 10 mg/kg Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 | Biological/Vaccine: MEDI6469 Monotherapy single intravenous (IV) administration of MEDI6469 |
| 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 | Biological/Vaccine: MEDI6469 Plus Tremelimumab MEDI6469 in combination with Tremelimumab |
| 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) | Biological/Vaccine: MEDI6469 Plus Tremelimumab MEDI6469 in combination with Tremelimumab |
| 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 | Biological/Vaccine: MEDI6469 Plus Durvalumab MEDI6469 in combination with Durvalumab |
| 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 | Biological/Vaccine: MEDI6469 Plus Durvalumab MEDI6469 in combination with Durvalumab |
| 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 | Biological/Vaccine: MEDI6469 Plus Durvalumab MEDI6469 in combination with Durvalumab |
| 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 | Biological/Vaccine: MEDI6469 plus Rituximab MEDI6469 in combination with Rituximab |
| 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 | Biological/Vaccine: MEDI6469 plus Rituximab MEDI6469 in combination with Rituximab |
Contacts
Investigators
Principal Investigator
MedImmune, LLC
MedImmune, LLC
