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
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ClinicalTrials.gov Identifier: NCT03906526 |
Recruitment Status :
Completed
First Posted : April 8, 2019
Last Update Posted : February 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Squamous Cell | Drug: VTX-2337 Drug: Nivolumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 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 |
Actual Primary Completion Date : | January 24, 2022 |
Actual Study Completion Date : | January 24, 2022 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03906526
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, Massachusetts | |
Boston University | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0501 | |
The Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center Hillman Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, South Dakota | |
Sanford Cancer Center | |
Sioux Falls, South Dakota, United States, 57104-8805 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Celgene |
ClinicalTrials.gov 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 25, 2022 |
Last Verified: | February 2022 |
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 |
Motolimod Nivolumab Head and Neck Cancer Squamous Cell Carcinoma |
Checkpoint inhibitor anti-PD1 inhibitor TLR 8 agonist |
Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |