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.
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.
WBC ≥2000/uL
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Receipt of any investigational anticancer therapy during the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy), excluding target lesions, Palliative radiation therapy cannot be administered less than 1 week prior to the first dose of study treatment.
Parallel
INCAGN01876
Drugagonistic antihuman GITR mAb
INCMGA00012
Drughumanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1
DPV-001
Biological/Vaccineautophagosome cancer vaccine
Adverse Events Assessment
frequency, duration, and severity of adverse events
ORR, DOR, DCR
Determined by investigator assessment per RECIST v1.1
Overall survival (OS)
Determined from the start of combination until death due to any cause
Duration of disease control
Measured from first report of SD or better (per RECIST v1.1) until PD or death
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