De-Escalation Therapy for Human Papillomavirus Negative Disease

Part of paid clinical trials in Chicago, Illinois.

Sponsor: University of Chicago
Study ID: NCT03944915
Phase: PHASE2
Status: Completed

Conditions

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

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Carboplatin — DRUG
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.
Paclitaxel — DRUG
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.
Nivolumab — DRUG
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
Hydroxyurea Pill — DRUG
One dose of hydroxyurea pill by mouth at start of 5-FU infusion during radiotherapy cycle
5-fluorouracil — DRUG
5-FU will be given by IV infusion continuously for 5 days during radiotherapy cycles
Filgrastim Injection — DRUG
Filgrastim shot will be given if patient has certain side effects during radiotherapy cycle on days 6-12.
Cisplatin — DRUG
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.

Study Details

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.