Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:7/15/2018
Start Date:June 28, 2018
End Date:December 31, 2020
Contact:Nabil F. Saba, MD
Email:nfsaba@emory.edu
Phone:404-778-4995

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Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work
together in treating participants with head and neck squamous cell cancer that has come back.
Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill
cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue.
Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to
grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better
at treating head and neck squamous cell cancer.

PRIMARY OBJECTIVE:

I. To assess the 1-year progression-free survival (PFS) for patients with recurrent or second
primary head and neck squamous cancer treated with intensity-modulated radiation therapy
(IMRT) re-irradiation with concurrent and adjuvant nivolumab.

SECONDARY OBJECTIVES:

I. Evaluate the 1-year (yr) overall survival (OS) of patients treated with re-irradiation and
nivolumab.

II. Evaluate patient quality of life (QOL).

III. Evaluate patterns of failure including local, regional and distant failure rates at 1
yr.

IV. Identify and estimate the incidence rate of acute and late toxicities associated with
combined re-irradiation and concurrent and adjuvant nivolumab.

TERTIARY OBJECTIVE:

I. To identify potential biomarkers related to clinical benefit to concurrent and adjuvant
nivolumab and re-irradiation in patients with recurrent or second primary (RSP) head and neck
squamous cell carcinoma (HNSCC).

OUTLINE:

Participants receive nivolumab intravenously (IV) over 30 minutes on weeks -2, 0, 2, 4, and 6
and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10,
participants receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up for 2 years from the
beginning of radiation therapy.

Inclusion Criteria:

- Patients with recurrent squamous cell carcinoma or a second primary arising in a
previously irradiated field

- Life expectancy of greater than 6 months

- Patients cannot have distant metastases and have to be candidates for curative
re-irradiation

- Patients with salivary gland tumors are excluded (patients with nasopharynx or
sinonasal cancers can participate)

- Patients with unresectable disease are eligible

- Patients who undergo surgical resection will be allowed regardless of human papilloma
virus (HPV) status provided they have one of the following criteria:

- Positive margins on pathology

- Evidence of extracapsular spread on nodal pathology

- Gross residual disease on postoperative or simulation imaging

- N2/3 disease

- T3/4 disease

- Multifocal perineural invasion and/or lymphovascular space invasion

- The majority of the anticipated target volume (> 50%) must have been previously
treated to ≥ 40 Gy; prior radiation therapy (RT) must have been completed > 6 months
prior to initiation of IMRT reirradiation; if previous RT records are unavailable,
investigators can estimate the dose to previously treated tissues based on completion
notes or other treatment history

- An Eastern Cooperative Oncology Group (ECOG) performance score 0-2

- Granulocytes > 1500/mm³

- Platelets > 100,000/mm³

- Bilirubin < 1.5 mg/dl

- Creatinine < 1.5 mg/dl

- No other concurrent invasive malignancies treated for the past year (localized
prostate cancer or early stage skin cancer are not exclusion criteria)

- Patients with carotid artery involvement or encasement will be allowed provided they
have no symptoms related to carotid involvement

- No prior exposure to immunotherapy agents

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Any known factors that would pose a contraindication to receiving nivolumab

- Recursive partitioning analysis (RPA) class III patients (expected to be treated less
than 2 years from first course of therapy and have a tracheostomy or percutaneous
endoscopic gastrostomy [PEG] tube at presentation)

- Patients with metastases

- Prior treatment with a programmed cell death protein-1 (PD-1)/programmed death-ligand
1 (PD-L1) inhibitor

- Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to enrollment

- Patients with primary salivary gland cancers are excluded

- Patients who have had chemotherapy or biological therapy within 4 weeks of
registration

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, autoimmune disease requiring systemic steroids, symptomatic congestive
heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements

- Patients who are pregnant or breast-feeding

- Patients with known active human immunodeficiency virus (HIV), hepatitis (hep) B, or
hep C infection

- Subjects with a condition requiring systemic treatment with either corticosteroids (>
10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of study drug administration; inhaled or topical steroids and adrenal replacement
doses > 10 mg daily prednisone equivalents are permitted in the absence of active
autoimmune disease
We found this trial at
4
sites
Atlanta, Georgia 30322
Principal Investigator: Nabil F. Saba, MD
Phone: 404-778-4995
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Nabil F. Saba, MD
Phone: 404-686-1858
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Shlomo A. Koyfman, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: Stuart J. Wong, MD
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Milwaukee, WI
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