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Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT05376553 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-18

No results posted yet for this study

Summary

The purpose of this research study is to determine the safety and tolerability of two dosing schedules of cemiplimab given in combination with cisplatin and docetaxel induction chemotherapy (TPI) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Cemiplimab is FDA approved for treatment of basal cell and squamous cell carcinoma of the skin as well as non-small cell lung cancer but not for squamous cell carcinoma of head and neck.

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Cemiplimab

350mg intravenous infusion over 30 minutes

DRUG

Cisplatin

100mg/m² intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)

DRUG

Docetaxel

75 mg/2 intravenous infusion over 60 minutes, mixed as described in Schedule: Day 1, every 21days (+ 2 days)

Sponsors & Collaborators

Principal Investigators

  • Krzysztof Misiukiewicz, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376553 on ClinicalTrials.gov