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A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer

  • identifier


  • Recruitment Status


  • First Posted

    April 8, 2019

  • Last update posted

    February 1, 2021

Study Description

Brief summary:

This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.

  • Condition or Disease:Carcinoma, Squamous Cell
  • Intervention/Treatment: Drug: VTX-2337
    Drug: Nivolumab
  • Phase: Phase 1

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 72 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Nivolumab in Subjects With Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: August 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Drug: VTX-2337

Drug: Nivolumab
IV Nivolumab
Experimental: Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Drug: VTX-2337

Drug: Nivolumab
IV Nivolumab
Experimental: Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
Drug: VTX-2337
Experimental: Monotherapy Arm 1: Nivolumab
Nivolumab IV every 2 weeks
Drug: Nivolumab
IV Nivolumab

Outcome Measures

  • Primary Outcome Measures: 1. Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery [ Time Frame: Screening through Study Day 52 ]
    Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment.
  • Secondary Outcome Measures: 1. Number of Patients With adverse events that lead to delay in resection [ Time Frame: Screening through Study Day 52 ]
    Study will evaluate the number of patients who experience adverse events that lead to a significant delay in surgical resection.
  • 2. Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod [ Time Frame: Up to approximately 112 days ]
    Subject will be monitored for AEs both during treatment and for a specified period after last dose of study treatment. AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Inclusion Criteria: - Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). - Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. - Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of the oral cavity, pharynx, or larynx - Macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery. - Subject consents to and has tumor accessible for tumor biopsy pre-treatment. - Subjects must have acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests. Exclusion Criteria: - Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study - Subject has unresectable or inoperable tumors - Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors - Subject has evidence of distant metastasis - Subject is a pregnant or nursing female. - Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C. - Subject has active autoimmune disease. - Subject has clinically significant ophthalmologic disease.

Contacts and Locations


Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599


United States, Alabama
University of Alabama at Birmingham

United States, California
University of California Los Angeles
Los Angeles

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City

United States, Kansas
University of Kansas

United States, Massachusetts
Boston University

United States, Missouri
Washington University
Saint Louis

United States, North Carolina
University of North Carolina
Chapel Hill

United States, Ohio
University of Cincinnati

United States, Ohio
The Ohio State University Comprehensive Cancer Center

United States, Pennsylvania
University of Pittsburgh Medical Center Hillman Cancer Center

United States, South Dakota
Sanford Cancer Center
Sioux Falls

Sponsors and Collaborators



Study Director: Amar Patel, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • Identifier: NCT03906526 History of Changes
  • Other Study ID Numbers: VTX-2337-HN-001, U1111-1223-3488
  • First Posted: April 8, 2019 Key Record Dates
  • Last Update Posted: February 1, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL:
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: TLR 8 agonist
    anti-PD1 inhibitor
    Checkpoint inhibitor
    Squamous Cell Carcinoma
    Head and Neck Cancer
  • Additional relevant MeSH terms: Carcinoma, Squamous Cell Carcinoma