NRG HN015

Trial Overview

Official Title

A PHASE II RANDOMIZED TRIAL OF NEOADJUVANT CHEMOTHERAPY OR CHEMO-IMMUNOTHERAPY IN PATIENTS WITH RECURRENT/PERSISTENT PD-L1 ENRICHED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK UNDERGOING SALVAGE SURGERY (NEOPOLIS)

Study Purpose

To assess and compare the long term outcome and side effects of patients treated with:

  1. chemotherapy (carboplatin + paclitaxel) prior to salvage surgery (SS) or
  2. chemo-immunotherapy (carboplatin +paclitaxel + cemiplimab) prior to salvage surgery (SS) or
  3. patients undergoing standard of care salvage surgery (SS) alone.

Diagnosis

Recurrent or persistent squamous cell cancer of Head or Neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx (mouth or throat area)

Eligibility

  • Biopsy proven diagnosis of locally recurrent or persistent (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx.
  • PD-L1 combined positive score (CPS) ≥ 1
  • Measurable disease

Intervention

In this study patients are “randomized” or assigned treatment by a computer without a choice

Randomization Arms:

  • Arm 1:  salvage surgery (SS)
  • Arm 2:  carboplatin + taxol + SS
  • Arm 3:  carboplatin + taxol + cemiplimab + SS

Patients may receive additional treatment after surgery depending on the pathology report

Post Operative Radiation Therapy (PORT) + Cisplatin 

For more information, click the link below:

https://clinicaltrials.gov/study/NCT07195734?term=nrg%20HN015&rank=1

Key Participation Requirements
Trial Location(s)
Methodist Estabrook Cancer Center
Gender
Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II