A Phase 1 Study of MEDI4736 in Combination with Tremelimumab in Participants with Advanced Solid Tumors
Study identifier:D4190C00010
ClinicalTrials.gov identifier:NCT02261220
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
380
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 13 Oct 2014
Primary Completion Date: 27 Jan 2020
Study Completion Date: 27 Jan 2020
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2021 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exploration Cohort Q2W Immunotherapy-naive participants with advanced solid tumors cancer will receive MEDI4736 IV Dose 1 every 2 weeks (Q2W) for 12 months (up to 26 doses) and IV tremelimumab Dose 2 every 4 weeks (Q4W) for 7 doses and then every 12 weeks (Q12W) for 2 doses (up to 9 doses in total) for 12 months. | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Exploration Cohort Q4W Immunotherapy-naive participants with advanced solid tumors cancer will receive MEDI4736 IV Dose 2 Q4W for 12 months (up to 13 doses) and IV tremelimumab Dose 1 Q4W for 7 doses and then Q12W for 2 doses (up to 9 doses in total) for 12 months. | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion SCLC Cohort Immunotherapy-naive participants with small cell lung cancer (SCLC) will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion STS Cohort Immunotherapy-naive participants with soft tissue sarcoma (STS) will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion HPV-positive Anogenital Cohort Immunotherapy-naive participants with human papillomavirus (HPV)-positive anogenital cancer will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion TNBC Cohort Immunotherapy-naive participants with triple-negative breast cancer (TNBC) will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion MSI-H CRC Cohort Immunotherapy-naive participants with microsatellite-instability high (MSI-H) colorectal cancer (CRC) will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion Ovarian Cohort Immunotherapy-naive participants with ovarian cancer will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Expansion UBC Cohort Immunotherapy-naive participants with urothelial bladder cancer (UBC) will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
| Experimental: Exploration IMT Pre-treated Cohort Immunotherapy pretreated participants with advanced solid tumors cancer will receive MEDI4736 IV Dose 2 Q4W and IV tremelimumab Dose 1 Q4W for up to 4 doses each, and later will receive monotherapy with MEDI4736 IV Dose 1 Q2W to complete a total of 12 months of therapy (up to 18 additional doses). | Biological/Vaccine: MEDI4736 MEDI4736 is administered by IV infusion in combination with tremelimumab Biological/Vaccine: tremelimumab Tremelimumab is administered by IV infusion in combination with MEDI4736 |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune, LLC
