NCT03944915

De-Escalation Therapy for Human Papillomavirus Negative Disease

A Phase II Trial of Carboplatin, Paclitaxel, and Nivolumab Induction Therapy Followed by Response-stratified Locoregional Therapy for Patients With Locally Advanced, HPV-negative Head and Neck Cancer. The DEPEND Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.

Conditions

• Human Papilloma Virus
• Squamous Cell Carcinoma
• Squamous Cell Carcinoma of the Head and Neck
• HPV-Related Squamous Cell Carcinoma
• HNSCC

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin will be given through IV infusions for 30-60 minutes on day 1 of each cycle. Each cycle will last 21 days. There will be 3 cycles.
DRUG	Paclitaxel	During Induction Therapy Paclitaxel (100 mg) will be given through IV infusions on days 1, 8 and 15 of each 21 day cycle. There will be 3 cycles. During Radiotherapy, paclitaxel will be given after a dose of radiation by IV infusion for 60 minutes after day 1 of radiotherapy.
DRUG	Nivolumab	Nivolumab will be given through IV infusions at 360 mg on day 1 every 21 days for 3 cycles.
RADIATION	Radiation	Patients will receive 4.5-5 cycles of radiation depending on response. Those with a positive response will receive radiation for 4.5 cycles with a total radiation dose of 66 Gy. Patients with a moderate or no response will receive 5 cycles with a total radiation dose of 70-75 Gy. 2 times a day for days 1-5 followed by a rest period for days 6-13
DRUG	Hydroxyurea Pill	One dose of hydroxyurea pill by mouth at start of 5-FU infusion during radiotherapy cycle
DRUG	5-fluorouracil	5-FU will be given by IV infusion continuously for 5 days during radiotherapy cycles
DRUG	Filgrastim Injection	Filgrastim shot will be given if patient has certain side effects during radiotherapy cycle on days 6-12.
DRUG	Cisplatin	Radiotherapy may also be given with a different chemotherapy agent called cisplatin. This is the traditional standard of care chemotherapy regimen. In this case, the radiotherapy will be given once daily for 5 days per week. Cisplatin will be administered via IV once every 21 days for 2 or 3 cycles.

Timeline

• Start date: 2019-08-26
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-05-10
• Last updated: 2025-05-11
• Results posted: 2025-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study