Window of Opportunity in Preserving Laryngeal Function Trial

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Matthew Spector
Study ID
NCT07423078
Phase
PHASE2
Status
Recruiting
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Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
  • Hypopharyngeal Squamous Cell Carcinoma
  • Locally Advanced Laryngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab — DRUG
    A monoclonal antibody (recombinant humanized programmed cell death protein 1 (PD-1) monoclonal antibody that acts as a checkpoint inhibitor) used for the treatment of melanoma and nasopharyngeal carcinoma.
  • Carboplatin — DRUG
    A chemotherapy medication classified as an alkylating agent. It contains the metal platinum, which binds to DNA in cancer cells, preventing their replication and leading to cell death. This mechanism makes it effective against rapidly dividing cells, such as cancer cells.
  • Cisplatin — DRUG
    \*Can be used in place of carboplatin at the investigator's discretion. A chemotherapy medication classified as an alkylating agent. It contains the metal platinum, which binds to DNA in cancer cells, preventing their replication and leading to cell death. This mechanism makes it effective against rapidly dividing cells, such as cancer cells.
  • Paclitaxel — DRUG
    A chemotherapy drug that works by slowing or stopping cancer cell growth.
  • Radiation Therapy — RADIATION
    Megavoltage energy photon beam irradiation. Any treatment planning and delivery system that has been credentialed for head and neck intensity-modulated radiotherapy (IMRT). Simultaneous integrated boost and sequential boost techniques (discretion of treating physician). Total doses delivered to each Planning Target Volume (PTV) (in 33-35 fractions): High: 70 Gy, Boost (if applicable): 66 Gy, Intermediate: 60-63 Gy, Elective: 56-57 Gy A sequential boost will consist of treatment of the combined PTVs 25 fractions followed by three sequential cone-downs targeting (Intermediate + Boost + High); (Boost + High); and High. Total doses for the PTVs: High: 70 Gy, Boost (if applicable): 66 Gy, Intermediate: 60 Gy, Elective: 50 Gy.

Study Details

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.

Key Dates

Start date
Apr 6, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2031

Study Design

Enrollment
87 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: toripalimab + carboplatin + paclitaxel
    Prior to treatment: Assessments include laryngoscopy and anatomic imaging studies Treatment: toripalimab 240mg IV with carboplatin (AUC 5) and paclitaxel (175 mg/m\^2) IV every 3 weeks for two cycles. (Cisplatin 75mg/m\^2 can be used in place of carboplatin at the investigator's discretion.) After 2 Cycles of Treatment: Repeat laryngoscopy and anatomic imaging studies. Undergo swallowing function and extranodal extension status assessment.
  • Experimental: Post-bioselection: Chemoradiation + toripalimab monotherapy
    Patients with PR ≥50% (not CR) with preserved swallowing function or CR, with preoperative N+ disease and extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: toripalimab 240mg IV + carboplatin (AUC 5) + paclitaxel (175 mg/m\^2) IV Q + Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles
  • Experimental: Post-bioselection: Radiation + toripalimab monotherapy
    Patients with CR, with preoperative N0 disease or N+ disease with no extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles

Primary Outcome Measure

1-Year Disease-free survival (DFS) [ Time Frame: At 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman CancerPittsburghPennsylvania15213
Jennifer Ruth, RN, BSN
[email protected]
412-623-8963
Mel J Mendez, BS
[email protected]
878-261-6071
Matthew Spector, MD, FACS (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Hillman Cancer· Pittsburgh, PA

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