Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Robert L. Ferris, MD, PhD
Study ID
NCT03715946
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Squamous Cell of Head and Neck
  • Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab Injection — DRUG
    A fully human anti-programmed death 1 (PD-1) monoclonal antibody
  • Radiotherapy (RT) — RADIATION
    45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week

Study Details

This clinical trial will evaluate a new combination of treatments for Oropharyngeal Squamous Cell cancers (OPSCC), and compare it to the current standard of care (concurrent, platinum-based chemoradiotherapy). Chemoradiotherapy is efficacious, but also associated with significant toxicities and is only suitable for patients with good performance status and without severe comorbidities. The purpose of this trial is to demonstrate equivalent oncologic outcome with fewer adverse effects and improved quality of life when compared to the standard of care.

Key Dates

Start date
Nov 16, 2018
Status verified
Jan 2025
Primary completion
Mar 31, 2023
Completion
Mar 31, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy (RT) + Nivolumab Injection
    RT of 45 or 50 Gy in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at 240 mg every 2 weeks during radiotherapy, and at 480 mg every 4 weeks for 6 doses after radiotherapy.

Primary Outcome Measure

One-year Progression-free Survival (PFS) [ Time Frame: At 1 year post start of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute @ Emory University Hospital MidtownAtlantaGeorgia30308-
Providence Cancer InstitutePortlandOregon97213-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Atlanta, GA

By research site
Winship Cancer Institute @ Emory University Hospital Midtown· Atlanta, GAProvidence Cancer Institute· Portland, ORUPMC Hillman Cancer Center· Pittsburgh, PA

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