Phase 2 N=62 Treatment

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

Recurrent Head and Neck Squamous Cell Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT03521570 ↗

Enrolled (actual)

Serious AEs

47.1%

Results posted

Sep 2024

Primary outcome: Primary: Number of Participants With Progression-Free Survival (PFS) — 27 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IMRT (Radiation); Nivolumab (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Progression-Free Survival (PFS)	27	—
SECONDARY Number of Participants With Overall Survival (OS)	84.4	—
SECONDARY Number of Participants With Pattern of Failure	2	—
SECONDARY Number of Participants With Incidence of Acute Adverse Events	82.4; 58.8; 54.9; 49; 47.1; 11.8	—
SECONDARY Number of Participants With Incidence of Late Adverse Events	3	—
SECONDARY Quality of Life (QOL)	68; 62.5; 62; 74.6; 59; 59	—

Summary

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients 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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03521570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.