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

NCT03906526 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: VTX-2337-HN-001U1111-1223-3488
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 12

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.

Conditions

Carcinoma, Squamous Cell

Keywords

Motolimod; Nivolumab; Head and Neck Cancer; Squamous Cell Carcinoma; Checkpoint inhibitor; anti-PD1 inhibitor; TLR 8 agonist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Patients With adverse events that lead to delay in resection

  Screening through Study Day 52

• Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod

  Up to approximately 112 days

Study Arms (4)

Monotherapy Arm 1: Nivolumab

EXPERIMENTAL

Nivolumab IV every 2 weeks

Drug: Nivolumab

Monotherapy Arm 2: Motolimod

EXPERIMENTAL

Motolimod IT injection weekly

Drug: VTX-2337

Combination Arm 3: Nivolumab and Motolimod

EXPERIMENTAL

Nivolumab IV every 2 weeks and Motolimod IT injection weekly

Drug: VTX-2337; Drug: Nivolumab

Combination Arm 4: Nivolumab and Motolimod

EXPERIMENTAL

Nivolumab IV every 2 weeks and Motolimod SC injection weekly

Drug: VTX-2337; Drug: Nivolumab

Interventions

VTX-2337 DRUG

Motolimod

Also known as: VTX-378

Combination Arm 3: Nivolumab and Motolimod; Combination Arm 4: Nivolumab and Motolimod; Monotherapy Arm 2: Motolimod

Nivolumab DRUG

IV Nivolumab

Also known as: Opdivo

Combination Arm 3: Nivolumab and Motolimod; Combination Arm 4: Nivolumab and Motolimod; Monotherapy Arm 1: Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (12)

Local Institution - 112

Birmingham, Alabama, 35294-3300, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Local Institution - 116

Boston, Massachusetts, 02215, United States

Location

Local Institution - 102

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0501, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Local Institution - 101

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 103

Sioux Falls, South Dakota, 57104-8805, United States

Location

Sanford Cancer Center

Sioux Falls, South Dakota, 57104-8805, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

VTX-2337; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: April 8, 2019
• Study Start: July 3, 2019
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (12)