Details

Details

Title 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

IRB WCI1318

CC 18-1547

Hospital Main Campus

Stage Recurrent/Relapsed

Phase Phase 2

Disease Squamous Cell Carcinoma of Head and Neck

Drug Nivolumab

Description

Description

Primary Objective
  • To assess the 1-year PFS for patients with recurrent or second primary head and neck squamous cancer treated with IMRT re-irradiation with concurrent and adjuvant nivolumab
Secondary Objectives
  • Evaluate the 1-yr OS of patients treated with re-irradiation and nivolumab
  • Evaluate patient QOL
  • Evaluate patterns of failure including local, regional and distant failure rates at 1yr
  • Identify and estimate the incidence rate of acute and late toxicities associated with combined re-irradiation and concurrent and adjuvant nivolumab
Exploratory Objectives
  • To identify potential biomarkers related to clinical benefit to concurrent and adjuvant nivolumab and re-irradiation in patients with RSP HNSCC.
Inclusion Criteria

Inclusion Criteria

  1. Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field
  2. Patients must be ≥ 18 years of age.
  3. Life expectancy of greater than 6 months.
  4. Patients cannot have distant metastases and have to be candidates for curative re-irradiation
  5. Patients with salivary gland tumors are excluded (patients with nasopharynx CA or sinonasal cancers can participate)
  6. Patients with unresectable disease are eligible.
  7. Patients who undergo surgical resection will be allowed regardless of HPV status provided they: have one of the following criteria: 1- Positive margins on pathology; 2- evidence of extracapsular spread on nodal pathology; 3- gross residual disease on postoperative or simulation imaging; 4 - N2/3 disease; 5 - T3/4 disease; 6 - multifocal perineural invasion and/or lymphovascular space invasion.
  8. The majority of the anticipated target volume (> 50%) must have been previously treated to ≥40Gy; Prior 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.
  9. An ECOG performance score 0-2 (see Appendix 1)
  10. Granulocytes >1500/mm3, platelets >100,000/mm3, bilirubin <1.5 mg/dl, creatinine <1.5 mg/dl
  11. No other concurrent invasive malignancies treated for the past year (localized prostate cancer or early stage skin cancer are not exclusion criteria);
  12. Patients with carotid artery involvement or encasement will be allowed provided they have no symptoms related to carotid involvement;
  13. No prior exposure to immunotherapy agents
  14. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria

Exclusion Criteria

  1. Any known factors that would pose a contraindication to receiving nivolumab
  2. RPA class III patients (expected to be treated less than 2 years from first course of therapy and have a tracheostomy or PEG tube at presentation)
  3. Patients with metastases
  4. Prior treatment with a PD-1/PD-L1 inhibitor.
  5. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
  6. Patients with primary salivary gland cancers are excluded.
  7. Patients who have had chemotherapy or biological therapy within 4 weeks of registration.
  8. 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.
  9. Patients who are pregnant or breast-feeding
  10. Patients with known active HIV, Hep B, or Hep C infection
  11. 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.