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

Carcinoma, Squamous Cell Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03906526
• Other study ID #: VTX-2337-HN-001
• Secondary ID: U1111-1223-3488
• Status: Terminated
• Phase: Phase 1
• Start date: July 3, 2019
• Est. completion date: January 24, 2022

Study information

• Verified date: February 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 24, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell

Intervention

Drug:
• VTX-2337
Motolimod
• Nivolumab
IV Nivolumab

Locations

Country	Name	City	State
United States	Local Institution - 112	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University	Boston	Massachusetts
United States	Local Institution - 116	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Local Institution - 101	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Local Institution - 102	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Local Institution - 103	Sioux Falls	South Dakota
United States	Sanford Cancer Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery	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	Number of Patients With adverse events that lead to delay in resection	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
Secondary	Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting