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

NCT03715946 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-13

Study results available
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Summary

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.

Conditions

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

Interventions

DRUG

Nivolumab Injection

A fully human anti-programmed death 1 (PD-1) monoclonal antibody

RADIATION

Radiotherapy (RT)

45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week

Sponsors & Collaborators

Principal Investigators

  • Robert Ferris, MD, PhD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2023-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715946 on ClinicalTrials.gov