Study identifier:D4190C00006
ClinicalTrials.gov identifier:NCT02000947
EudraCT identifier:2015-003715-38
CTIS identifier:N/A
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
NSCLC
Phase 1
No
MEDI4736, Tremelimumab
All
457
Interventional
18 Years - 101 Years
Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Sept 2020 by MedImmune, LLC
MedImmune, LLC
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The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).
This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI4736 in combination with tremelimumab to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity of MEDI4736 in combination with tremelimumab in adult subjects with advanced NSCLC.
Location
Location
Tampa, FL, United States, 33612
Location
New Haven, CT, United States, 06510
Location
Los Angeles, CA, United States, 90025
Location
New York, NY, United States, 10065
Location
Portland, OR, United States, 97213
Location
Seattle, WA, United States, 98109
Location
New York, NY, United States, 10032
Location
Boston, MA, United States, 02215
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). |
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