A Phase 1b Study of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-small Cell Lung Cancer - D4190C00006
Study identifier:D4190C00006
ClinicalTrials.gov identifier:NCT02000947
EudraCT identifier:2015-003715-38
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-small Cell Lung Cancer
Medical condition
NSCLC
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI4736, Tremelimumab
Sex
All
Actual Enrollment
457
Study type
Interventional
Age
18 Years - 101 Years
Date
Study Start Date: 25 Oct 2013
Primary Completion Date: 17 Sept 2019
Study Completion Date: 17 Sept 2019
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Total Escalation Participants will receive MEDI4736 IV escalation doses (Dose 1 or 2 or 3 or 4 ) every 4 weeks (Q4W; up to 13 doses) or every two weeks (Q2W; up to 26 doses) and IV tremelimumab dose (Dose 1, 2, or 3) Q4W for 6 doses and then every 12 weeks (Q12W) for 3 doses (up to 9 doses in total) for 12 months or until disease progression. | Drug: MEDI4736 MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb). Drug: Tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb). |
| Experimental: Expansion Cohort A Treatment-naïve, non-epidermal growth factor receptor (non-EGFR) mutation positive, and non-anaplastic lymphoma kinase (non-ALK) rearrangement positive participants will receive IV MEDI4736 Dose 4 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, followed by monotherapy with IV MEDI4736 Dose 4 Q4W for 9 doses to complete a total of 12 months of therapy or until disease progression. | Drug: MEDI4736 MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb). Drug: Tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb). |
| Experimental: Expansion Cohort B (Co-Adminstration dosing) Immunotherapy-naive participants will receive co-administration of IV MEDI4736 Dose 4 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, followed by monotherapy with IV MEDI4736 Dose 4 Q4W for 9 doses to complete a total of 12 months of therapy or until disease progression. | Drug: MEDI4736 MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb). Drug: Tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb). |
| Experimental: Expansion Cohort C (Relapsed) Participants whom disease was relapsed with the previous immunotherapy treatment will receive IV infusion of MEDI4736 Dose 4 Q4W and tremelimumab Dose 1 Q4W for up to 4 doses each, followed by monotherapy with IV MEDI4736 Dose 4 Q4W for 9 doses to complete a total of 12 months of therapy or until disease progression. | Drug: MEDI4736 MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb). Drug: Tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb). |
| Experimental: Expansion Cohort B (Sequential Adminstration) Immunotherapy-naive participants will receive sequential administration of IV MEDI4736 Dose 4 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, followed by monotherapy with IV MEDI4736 Dose 4 Q4W monotherapy for 9 doses to complete a total of 12 months of therapy or until disease progression. | Drug: MEDI4736 MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb). Drug: Tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb). |
| Experimental: Expansion Cohort C (Refractory) Participants who were refractory to previous immunotherapy treatment will receive IV infusion of MEDI4736 Dose 4 Q4W and tremelimumab Dose 1 Q4W for up to 4 doses each, followed by monotherapy with IV MEDI4736 Dose 4 Q4W for 9 doses to complete a total of 12 months of therapy or until disease progression. | Drug: MEDI4736 MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb). Drug: Tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb). |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune
