Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer

Conditions

• Head and Neck Cancer
• Human Papilloma Virus

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• MEDI0457 — DRUG
  MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.
• CELLECTRA®5P device — DEVICE
  MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device.
• Durvalumab — DRUG
  Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks.

Study Details

This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80). An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.

Key Dates

Start date

Jun 26, 2017

Status verified

Aug 2022

Primary completion

Mar 19, 2021

Completion

Mar 19, 2021

Study Design

Enrollment

35 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 through 90 days after the last dose of study drug (approximately 45 months) ]

Locations (14)

Find similar trials in San Francisco, CA

Related Studies

• Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer
  Recruiting · Stanford University · Stanford, California
• Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
  Recruiting · Stanford University · Stanford, California
• Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• New MRI Biomarkers in Head and Neck Cancers
  Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York