drugset / Trial / NCT04862650

Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT04862650

Phase 2 Active not recruiting 46 enrolled Marcelo Bonomi
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

Timeline

Start
2021-11-30
Primary completion
2026-06-12
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 1 unknown Intravenous
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous
Subject Paclitaxel Small molecule 25 mg/m2 Intravenous