Safety and efficacy of MEDI0457 and Durvalumab in participants with Human Papilloma Virus (HPV) associated recurrent/metastatic head and neck cancer
Study identifier:D8860C00005
ClinicalTrials.gov identifier:NCT03162224
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1b/2a, Multi-Center Open-Label Study to Evaluate the Safety and Efficacy of Combination Treatment with MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients with Recurrent/Metastatic HPV Associated Head and Neck Squamous Cancer
Medical condition
head and neck cancer
Phase
Phase 1/2
Healthy volunteers
No
Study drug
MEDI0457, Durvalumab
Sex
All
Actual Enrollment
35
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 26 Jun 2017
Primary Completion Date: 19 Mar 2021
Study Completion Date: 19 Mar 2021
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2022 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: First-line Recurrent/Metastatic (1L R/M) Platinum Non-refractory Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then every 8 weeks (Q8W) and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then every 4 weeks (Q4W) until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. | Drug: MEDI0457 MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device. Other Name: INO-3112 Device: CELLECTRA®5P device MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device. Other Name: CELLECTRA 2000 Drug: Durvalumab Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks. Other Name: MEDI4736 |
| Experimental: 1L R/M Platinum Refractory Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. | Drug: MEDI0457 MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device. Other Name: INO-3112 Device: CELLECTRA®5P device MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device. Other Name: CELLECTRA 2000 Drug: Durvalumab Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks. Other Name: MEDI4736 |
| Experimental: Second-line (2L) + R/M Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. | Drug: MEDI0457 MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device. Other Name: INO-3112 Device: CELLECTRA®5P device MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device. Other Name: CELLECTRA 2000 Drug: Durvalumab Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks. Other Name: MEDI4736 |
Contacts
Investigators
Principal Investigator
MedImmune LLC
Study Director
