Window of Opportunity in Preserving Laryngeal Function Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Spector

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

87 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Matthew Spector

Lead sponsor

University of Pittsburgh

Sponsor institution

Coherus Oncology, Inc.

Collaborator