CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Nivolumab Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03715946
NCT03715946Phase 2Completed

Phase II Trial of Adjuvant De-Escalated Radiation + Concurrent and Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer

Robert L. Ferris, MD, PhD·interventional·Posted Oct 23, 2018·Updated Jan 13, 2025

In Brief

A Phase 2 clinical trial evaluating Nivolumab Injection and Radiotherapy (RT) for Carcinoma, Squamous Cell of Head and Neck and Oropharynx Squamous Cell Carcinoma. Completed, enrolled 40 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 23, 2018
Enrollment StartNov 16, 2018
Primary CompletionMar 31, 2023
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.7 years ago

Interventions

Nivolumab Injectiondrug

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