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

February 23, 2023 updated by: Celgene

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35294-3300
        • Local Institution - 112
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 116
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 102
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0501
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Comprehensive Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 101
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104-8805
        • Sanford Cancer Center
      • Sioux Falls, South Dakota, United States, 57104-8805
        • Local Institution - 103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy Arm 1: Nivolumab
Nivolumab IV every 2 weeks
Drug: Nivolumab
IV Nivolumab
Other Names:
  • Opdivo
Experimental: Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
Drug: VTX-2337
Motolimod
Other Names:
  • VTX-378
Experimental: Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Drug: Nivolumab
IV Nivolumab
Other Names:
  • Opdivo
Drug: VTX-2337
Motolimod
Other Names:
  • VTX-378
Experimental: Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Drug: Nivolumab
IV Nivolumab
Other Names:
  • Opdivo
Drug: VTX-2337
Motolimod
Other Names:
  • VTX-378

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening through Study Day 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening through Study Day 52
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.
Up to approximately 112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2019

Primary Completion (Actual)

January 24, 2022

Study Completion (Actual)

January 24, 2022

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTX-2337-HN-001
  • U1111-1223-3488 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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