An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)
An Exploratory Tumor Biopsy-Driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Immunomodulatory Treatment-Naïve Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck Receiving REGN2810 (Anti-PD-1)
2 other identifiers
interventional
33
2 countries
6
Brief Summary
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2017
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
July 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedMarch 19, 2020
March 1, 2020
2 years
June 19, 2017
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.
At baseline and during REGN2810 treatment up to week 24
Secondary Outcomes (6)
Correlation between baseline tumor characteristics and the change in tumor volume following REGN2810 treatment
At baseline and during REGN2810 treatment up to week 24
Number of participants with treatment-related adverse events
Up to 54 weeks
Concentrations of REGN2810 in serum
Up to 54 weeks
Anti-REGN2810 antibody levels
Up to 54 weeks
The overall response rate (ORR) in patients treated with REGN2810
Up to 54 weeks
- +1 more secondary outcomes
Study Arms (1)
REGN2810
EXPERIMENTALREGN2810 administered IV over a 30 minute infusion
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of recurrent and/or metastatic SCCHN (squamous cell carcinoma of the head and neck) with no curative options with at least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and accessible for biopsies. Primary tumor sites of oral cavity, oropharynx, larynx, or hypopharynx are included.
- Have failed/are refractory to at least first line chemotherapy OR deemed unsuitable candidate for first line chemotherapy due to medical co-morbidities or patient preference
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate hepatic function
- Adequate renal function
- Adequate bone marrow function
- Provide signed informed consent
- Willing and able to comply with clinic visits and study-related procedures
You may not qualify if:
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse event (irAEs)
- Prior treatment with an agent that blocks the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway
- Prior treatment with other immune modulating anti-cancer agents
- Untreated or active brain metastases or spinal cord compression
- Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of REGN2810
- Prior treatment with idelalisib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (6)
Seoul National University
Seoul, 03080, South Korea
Yonsei University College of Medicine, Severence Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
University Birmingham
Birmingham, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Royal Cancer Hospital
London, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
June 23, 2017
Study Start
July 3, 2017
Primary Completion
June 27, 2019
Study Completion
February 21, 2020
Last Updated
March 19, 2020
Record last verified: 2020-03