De-Escalation Therapy for Human Papillomavirus Negative Disease

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

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.

Sponsors & Collaborators

• University of Chicago

  lead OTHER

Principal Investigators

• Everett Vokes, MD · University of Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-26

Primary Completion

2023-11-01

Completion

2023-11-01

FDA Drug

Yes

Countries

• United States

Study Locations