Phase 2 toripalimab PD-1 (CD279) antibody “priming” before paclitaxel microtubule inhibitor in HNSCC

This Phase 2 pilot, single-arm, sequential regimen study at Barbara Ann Karmanos Cancer Institute tests whether upfront toripalimab (a PD-1 immune checkpoint–blocking monoclonal antibody; Coherus BioSciences/Junshi Biosciences) can “prime” anti-tumor immunity and improve subsequent response to paclitaxel (a taxane that stabilizes microtubules and blocks mitosis; widely generic) in recurrent/metastatic, unresectable stage IV-C head and neck squamous cell carcinoma patients who specifically have ECOG performance status 2—an under-studied, higher-risk group often excluded from pivotal immunotherapy trials. Patients receive toripalimab 240 mg on weeks 1, 4, and 7, then paclitaxel 80 mg/m² weekly (weeks 8–15), followed by a 2-week break, repeating for up to three 17-week cycles. Key outcomes include response rate after toripalimab priming, time to progression while cycling therapy, quality of life, and overall survival. Today’s care for R/R or metastatic HNSCC typically centers on PD-1–based therapy (often pembrolizumab) with or without platinum/5-FU and later-line single-agent chemotherapy or cetuximab; this study explores a tolerability-focused sequencing strategy for patients with poorer functional status.