← Back to Search

Radiation Therapy

IMRT + Nivolumab for Recurrent Head and Neck Cancer

Phase 2
Waitlist Available
Led By Nabil F. Saba, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field
Patients cannot have distant metastases and have to be candidates for curative re-irradiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years from study start
Awards & highlights

Study Summary

This trial studies how well two cancer treatments work together in treating patients with head and neck squamous cell cancer that has come back.

Who is the study for?
This trial is for adults with head and neck squamous cell cancer that has returned. They must have had prior radiation, be fit enough for re-irradiation, not have distant metastases or other cancers in the last year, and no previous immunotherapy. Patients should be able to perform daily activities with minimal assistance (ECOG score 0-2) and have adequate organ function.Check my eligibility
What is being tested?
The study is testing a combination of intensity-modulated radiotherapy (IMRT), which targets tumors while sparing healthy tissue, and nivolumab, an antibody drug designed to block cancer growth by enhancing the immune response against tumor cells.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs like lungs or intestines, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, infusion reactions and can increase the risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has returned or I have a new cancer in an area previously treated with radiation.
Select...
My cancer has not spread far and can be treated with targeted radiation again.
Select...
I had surgery to remove a part of my body affected by disease.
Select...
My last radiation therapy was over 6 months ago.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I haven't been treated for any other cancer in the past year.
Select...
My carotid artery is affected by my condition but I have no symptoms from it.
Select...
I have never been treated with immunotherapy.
Select...
Most of my cancer treatment area has been exposed to a high dose of radiation.
Select...
My condition cannot be treated with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years from study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1 year progression-free survival (PFS)
Secondary outcome measures
1 year overall survival (OS)
Incidence of acute adverse events
Incidence of late adverse events
+2 more

Side effects data

From 2021 Phase 2 trial • 27 Patients • NCT01882816
81%
Lymphocyte count decreased
15%
White blood cell decreased
15%
Anemia
15%
Hyperglycemia
15%
Neutrophil count decreased
11%
Stridor
11%
Hypocalcemia
11%
Platelet count decreased
4%
Stoma site infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
IMRT and Doxorubicin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, IMRT)Experimental Treatment2 Interventions
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMRT
2003
Completed Phase 3
~1570
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,528 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,616 Total Patients Enrolled
Medical College of WisconsinOTHER
609 Previous Clinical Trials
1,162,532 Total Patients Enrolled

Media Library

Head and Neck Squamous Cell Carcinoma Research Study Groups: Treatment (nivolumab, IMRT)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What further investigations have been conducted into the use of IMRT?

"Presently, there are 717 IMRT trials in progress. Of these clinical experiments, 82 have reached the third phase of testing. Basel, BE is home to the majority of trials for this treatment; however, 40281 other locations also offer studies concerning its application."

Answered by AI

How many participants is the clinical trial currently involving?

"As of the last edit on February 2, 2022, this clinical trial is not open to new participants. However, those seeking alternatives may find that there are presently 1752 trials recruiting patients with squamous cell carcinoma and 717 studies looking for applicants undergoing IMRT (intensity modulated radiotherapy)."

Answered by AI

Has Intensity Modulated Radiation Therapy been sanctioned by the FDA?

"Although there is some evidence of IMRT's safety, it has yet to be clinically proven. Thus, our team at Power rates this drug a 2 on their scale from 1-3."

Answered by AI

What ailments are usually managed with the assistance of IMRT?

"Intensity modulated radiation therapy (IMRT) is often used to treat malignant neoplasms, though it may also be applied in cases such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Is there currently an opportunity to join this experiment?

"Per information hosted on clinicaltrials.gov, this research program is not actively recruiting patients as of right now. It was initially posted on June 28th 2018 and the latest version went public on February 2nd 2022. Although no longer enrolling participants, there are still 2469 other trials with open positions at present."

Answered by AI

Is this research a pioneering endeavor?

"IMRT has been studied since 2012, when Ono Pharmaceutical Co. Ltd sponsored the first trial of 659 participants. Subsequently, IMRT was granted Phase 1 & 2 drug approval and is now being trialed in 49 countries across 2356 cities with 717 active studies currently underway."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer
Nabil F. Saba 2018. "Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03521570.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top