A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Providence Health & Services
Summary
This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.
Description
This is a phase Ib trial of an autophagosome vaccine (DPV-001) with or without anti-GITR (INCAGN01876), combined with subsequent anti-PD1 (INCMGA00012), in patients with recurrent or metastatic HNSCC. Eligible patients will be registered and assigned to one of two treatment arms. Subjects in Arm 1 will receive combination therapy with DPV-001 with delayed anti-PD-1, and subjects in Arm 2 will receive DPV-001 and anti-GITR with delayed anti-PD-1 (triplet therapy). Mandatory biopsy will occur at week 2. Initial restaging CT and mandatory biopsy will occur at 8 weeks, followed by confirmatory CT…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix C) * Age 18 years or above. * Laboratory values: * WBC ≥2000/uL * Hgb \>8.0 g/dl (patients may be transfused to reach this level) * Platelets \>75,000 cells/mm3 * Serum creatinine clearance ≥ 50 mL/min measured or calculated by Cockcroft-Gault (C-G) equation * Negative bHCG (urine/serum) Women of childbearing potential only * AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of laboratory normal (ULN) OR ≤ 5 ×…
Interventions
- DrugINCAGN01876
agonistic antihuman GITR mAb
- DrugINCMGA00012
humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1
- BiologicalDPV-001
autophagosome cancer vaccine
Location
- Portland Providence Medical CenterPortland, Oregon