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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT03906526

Recruitment Status Recruiting

First Posted April 8, 2019

Last update posted September 1, 2020

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

N/A

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: December 2020
  • 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
Motolimod

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

Drug: Nivolumab
IV Nivolumab
Experimental: Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
Drug: VTX-2337
Motolimod
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
Criteria

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
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 11 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Amar Patel, MD Celgene Corporation

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov 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: September 1, 2020
  • Last Verified: August 2020
  • 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: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • 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: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Motolimod
    Nivolumab
    Head and Neck Cancer
    Squamous Cell Carcinoma
    Checkpoint inhibitor
    anti-PD1 inhibitor
    TLR 8 agonist
  • Additional relevant MeSH terms: Carcinoma Carcinoma, Squamous Cell