Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

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)

Keywords

Carcinoma, Squamous Cell Motolimod Nivolumab Head and Neck Cancer Squamous Cell Carcinoma Checkpoint inhibitor anti-PD1 inhibitor TLR 8 agonist Carcinoma VTX-2337

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • The University of Texas Southwestern Medical Center not yet accepting patients
    Dallas Texas 75390 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03906526
Phase
Phase 1
Study Type
Interventional
Last Updated