NCT03894891

Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer

Sequential Therapy With Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being performed to treat patient for head and neck cancer patients who have not received prior chemotherapy.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug or combination of interventions is being studied. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or advanced head and neck cancer (head and neck cancer that has come back or is incurable) but is considered investigational for head and neck cancer patients who have not received prior chemotherapy.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is a type of immunotherapy.
DRUG	Cisplatin	Cisplatin is a chemotherapy drug.
DRUG	Docetaxel	Docetaxel is a chemotherapy drug.
RADIATION	Intensity-modulated radiotherapy	IMRT is definitive treatment for head and neck cancer.

Timeline

• Start date: 2019-06-11
• Primary completion: 2022-10-31
• Completion: 2022-12-16
• First posted: 2019-03-29
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study