A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) with Tremelimumab in Head and Neck Cancer
Study identifier:D4190C00011
ClinicalTrials.gov identifier:NCT02262741
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination with Tremelimumab in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Medical condition
Squamous cell carcinoma of the head and neck
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI4736, Tremelimumab
Sex
All
Actual Enrollment
71
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 15 Oct 2014
Primary Completion Date: 21 Sept 2017
Study Completion Date: 21 Sept 2017
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2021 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Exploration Cohort Q2W Participants will receive intravenous (IV) MEDI4736 Dose 1 once every two weeks (Q2W) for 12 months (up to 26 doses) along with tremelimumab Dose 2 once every 4 weeks (Q4W) for 7 doses and then once every 12 weeks (Q12W) for 2 doses (for a total of up to 9 doses) for 12 months. | Drug: MEDI4736 MEDI4736 Dose 1 or Dose 2 will be administered by IV infusion in combination with tremelimumab. Drug: Tremelimumab Tremelimumab Dose 1 or Dose 2 will be administered by IV infusion in combination with MEDI4736. |
| Experimental: Exploration Cohort Q4W Participants will receive IV MEDI4736 Dose 2 Q4W for 12 months (up to 13 doses) along with tremelimumab Dose 1 Q4W for 7 doses and then Q12W for 2 doses (for a total of up to 9 doses) for 12 months. | Drug: MEDI4736 MEDI4736 Dose 1 or Dose 2 will be administered by IV infusion in combination with tremelimumab. Drug: Tremelimumab Tremelimumab Dose 1 or Dose 2 will be administered by IV infusion in combination with MEDI4736. |
| Experimental: Expansion Cohort A Programmed cell death ligand 1-high (PD-L1-High) participants will receive IV infusion of MEDI4736 Dose 2 and tremelimumab Dose 1 Q4W for up to 4 doses each up to Week 13. From Week 17, the participants will continue with IV MEDI4736 Dose 1 Q2W for 12 months (up to 18 additional doses). | Drug: MEDI4736 MEDI4736 Dose 1 or Dose 2 will be administered by IV infusion in combination with tremelimumab. Drug: Tremelimumab Tremelimumab Dose 1 or Dose 2 will be administered by IV infusion in combination with MEDI4736. |
| Experimental: Expansion Cohort B rogrammed cell death ligand 1-low/negative (PDL1- low/negative) participants will receive IV infusion of MEDI4736 Dose 2 and tremelimumab Dose 1 Q4W for up to 4 doses each up to Week 13. From Week 17, the participants will continue with IV MEDI4736 Dose 1 Q2W for 12 months (up to 18 additional doses). | Drug: MEDI4736 MEDI4736 Dose 1 or Dose 2 will be administered by IV infusion in combination with tremelimumab. Drug: Tremelimumab Tremelimumab Dose 1 or Dose 2 will be administered by IV infusion in combination with MEDI4736. |
| Experimental: Expansion Cohort C Immunotherapy (IMT) pretreated (regardless of tumoral PD-L1 expression) participants will receive IV infusion of MEDI4736 Dose 2 and tremelimumab Dose 1 Q4W for up to 4 doses each up to Week 13. From Week 17, the participants will continue with IV MEDI4736 Dose 1 Q2W for 12 months (up to 18 additional doses). | Drug: MEDI4736 MEDI4736 Dose 1 or Dose 2 will be administered by IV infusion in combination with tremelimumab. Drug: Tremelimumab Tremelimumab Dose 1 or Dose 2 will be administered by IV infusion in combination with MEDI4736. |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune, LLC
