About this trial
This trial will study the safety and tolerability and disease survival rates in adult patients with recurrent/metastatic (R/M) HNSCC when treated with carboplatin or cisplatin, paclitaxel, and toripalimab.
Eligibility criteria
Qualifiers
Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx
AJCC 8th Edition Stage III - IV disease (T1-T2/N1-N3, T3-T4/N0-N3)
Disease (primary & nodal) must be potentially surgically resectable and curable with conventional surgery and CRT
ECOG PS 0 - 2
Disqualifiers
Prior treatment for head and neck cancer
Unresectable laryngeal or hypopharyngeal squamous cell carcinoma
Distant metastatic disease
Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism or Sjogren's syndrome will not be excluded from the study.
Trial design
Treatments tested in this trial
- Toripalimab
- Carboplatin
- Cisplatin
- Paclitaxel
- Radiation Therapy
Treatment groups
Sponsors and collaborators
Matthew Spector
Lead sponsor
University of Pittsburgh
Sponsor institution
Coherus Oncology, Inc.
Collaborator