Window of Opportunity in Preserving Laryngeal Function Trial (NCT07423078) | Clinical Trial Compass
RecruitingPhase 2
Window of Opportunity in Preserving Laryngeal Function Trial
United States87 participantsStarted 2026-04-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
✓. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
✓. Must have normal organ and marrow function as defined below:
✓. Must have the ability to understand and the willingness to sign a written informed consent document.
✕. 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.
✕. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.
✕. Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel.
✕. Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes for the patient.
✕. Peripheral sensory neuropathy \> grade 2 by CTCAE v5.0