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Clinical Trials/NCT03198130
NCT03198130CompletedPhase 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)

Regeneron Pharmaceuticals6 sites in 2 countries33 target enrollmentStarted: July 3, 2017Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
33
Locations
6
Primary Endpoint
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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
  • •Other protocol-defined inclusion/exclusion criteria will apply

Arms & Interventions

REGN2810

Experimental

REGN2810 administered IV over a 30 minute infusion

Intervention: REGN2810 (Drug)

Outcomes

Primary Outcomes

Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline.

Time Frame: At baseline and during REGN2810 treatment up to week 24

Secondary Outcomes

  • The progression-free survival (PFS) in patients treated with REGN2810(Up to 54 weeks)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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