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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03906526
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : February 1, 2021
Information provided by (Responsible Party):

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 Intervention/treatment Phase
Carcinoma, Squamous Cell Drug: VTX-2337 Drug: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
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 3, 2019
Estimated Primary Completion Date : May 10, 2022
Estimated Study Completion Date : August 8, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Monotherapy Arm 1: Nivolumab
Nivolumab IV every 2 weeks
Drug: Nivolumab
IV Nivolumab
Other Name: Opdivo

Experimental: Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
Drug: VTX-2337
Other Name: VTX-378

Experimental: Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Drug: VTX-2337
Other Name: VTX-378

Drug: Nivolumab
IV Nivolumab
Other Name: Opdivo

Experimental: Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Drug: VTX-2337
Other Name: VTX-378

Drug: Nivolumab
IV Nivolumab
Other Name: Opdivo

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.

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03906526

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

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
United States, Iowa
University of Iowa Hospitals and Clinics Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Not yet recruiting
Westwood, Kansas, United States, 66205
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45267-0501
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Dakota
Sanford Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 57104-8805
Sponsors and Collaborators
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Study Director: Amar Patel, MD Celgene Corporation
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Responsible Party: Celgene Identifier: NCT03906526    
Other Study ID Numbers: VTX-2337-HN-001
U1111-1223-3488 ( Registry Identifier: WHO )
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Head and Neck Cancer
Squamous Cell Carcinoma
Checkpoint inhibitor
anti-PD1 inhibitor
TLR 8 agonist
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents