CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Nivolumab +1 morebiological
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/NCT03521570
NCT03521570Phase 2Completed

Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck

Emory University·interventional·Posted May 11, 2018·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating IMRT and Nivolumab for Recurrent Head and Neck Squamous Cell Carcinoma. Completed, enrolled 62 participants across 4 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 11, 2018
Enrollment StartJun 28, 2018
Primary CompletionJul 25, 2022
Study CompletionSep 7, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.1 years ago

Interventions

IMRTradiation

Undergo intensity-modulated radiation therapy

Nivolumabbiological

Given IV