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NOT YET RECRUITING
NCT07423078
PHASE2

Window of Opportunity in Preserving Laryngeal Function Trial

Sponsor: Matthew Spector

View on ClinicalTrials.gov

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.

Official title: A Phase II Window of Opportunity in Preserving Laryngeal Function (WOLF) Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2026-03-31

Completion Date

2031-03-31

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Toripalimab

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.

DRUG

Carboplatin

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.

DRUG

Cisplatin

\*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.

DRUG

Paclitaxel

A chemotherapy drug that works by slowing or stopping cancer cell growth.

RADIATION

Radiation Therapy

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.

Locations (1)

UPMC Hillman Cancer

Pittsburgh, Pennsylvania, United States