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Monoclonal Antibodies

Radiation Therapy + Immunotherapy for Head and Neck Cancer

Phase 2 & 3
Waitlist Available
Led By Loren K Mell
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have locoregionally advanced head and neck squamous cell carcinoma (HNSCC)
For patients with oropharyngeal or unknown primaries: p16 determination by immunohistochemistry confirmed by central pathology review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing how well radiation therapy works with durvalumab or cetuximab to treat patients with head and neck cancer that has spread.

Who is the study for?
This trial is for adults with advanced head and neck cancer who can't use cisplatin. They must have untreated, unresected squamous cell carcinoma in specific regions (larynx, hypopharynx, oropharynx, oral cavity) and meet health criteria like blood counts and organ function tests. Pregnant women are excluded, as are those with recent cancers (except certain skin/prostate cancers), severe illnesses or allergies to the drugs tested.Check my eligibility
What is being tested?
The study compares radiation therapy combined with durvalumab (an immunotherapy drug) versus cetuximab (another type of monoclonal antibody). It aims to see which combination works better for shrinking tumors in patients who cannot take cisplatin.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect organs, infusion reactions from the antibodies used, fatigue, skin rashes and allergic responses. Durvalumab may also cause changes in liver enzymes and cetuximab might trigger acne-like rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have advanced cancer in my head or neck area.
Select...
My throat cancer is p16 positive, confirmed by a specialized lab.
Select...
I have submitted tissue samples for review and analysis to UCSF.
Select...
I cannot take cisplatin due to health reasons.
Select...
I have a confirmed, untreated squamous cell carcinoma in my head or neck area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(Lead-in) Number of Participants With Dose-limiting Toxicity (DLT)
Overall Survival (Percentage of Participants Alive)
Progression-free Survival (Percentage of Participants Alive Without Progression)
Secondary outcome measures
Change in Quality of Life (QOL) Analysis
Change in Swallowing QOL Using Total Composite M. D. Anderson Dysphagia Inventory (MDADI) Score
Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer)
+5 more
Other outcome measures
Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
QOL Endpoints Using Other Items in EORTC QLQ/HN35, EQ5D and MDADI Subscales
Secondary Biomarker Analysis

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (durvalumab, radiation therapy)Experimental Treatment5 Interventions
Patients receive durvalumab IV over 60 minutes every 4 weeks. Treatment repeats every 4 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients undergo IMRT 5 fractions per week for up to 7 weeks.
Group II: Arm I (cetuximab, radiation therapy)Active Control5 Interventions
Patients receive cetuximab IV weekly over 60-120 minutes. Treatment repeats every week for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Beginning 5-7 days after first cetuximab dose, patients undergo IMRT 5 fractions per week for up to 7 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
67,257 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,656 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,957 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03258554 — Phase 2 & 3
Oropharyngeal Cancer Research Study Groups: Arm II (durvalumab, radiation therapy), Arm I (cetuximab, radiation therapy)
Oropharyngeal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT03258554 — Phase 2 & 3
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03258554 — Phase 2 & 3

Frequently Asked Questions

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

For what sorts of ailments is Durvalumab commonly prescribed?

"Durvalumab can be used as treatment for disease, metastatic squamous cell carcinoma of the head and neck (hnscc), and squamous cell carcinoma."

Answered by AI

Does Durvalumab have a history of being studied in other patient populations?

"Currently, 471 clinical studies are observing the effects of Durvalumab with 80 in Phase 3. Although several investigations for Durvalumab are based in Blacktown, New South Wales, there are a total of 18324 locations running similar trials."

Answered by AI

Is this a new or an existing clinical trial?

"Durvalumab has 471 active studies in 60 countries and 1849 cities. The first study involving Durvalumab was completed in 2005 by Bristol-Myers Squibb. That initial trial included 154 patients and reached Phase 2 of the drug approval process. In the 15 years since that study, 1197 more have been completed."

Answered by AI

How many people can join this trial at most?

"Unfortunately, this study is no longer enrolling patients. It was last updated on September 3rd, 2022 and had originally been posted December 12th, 2017. However, there are presently 471 other clinical trials for Durvalumab therapy recruiting patients and 3132 trials in general for malignant neoplasms."

Answered by AI

Where are the trial sites for this research project located?

"There are over 100 enrolment locations for this clinical trial, including Norton Brownsboro Hospital and Medical Campus in Louisville, Kentucky, Salina Regional Health Center in Salina, Kansas, and Memorial Sloan Kettering Westchester in Harrison, New york."

Answered by AI

Are there any available positions for people who want to participate in this research?

"The trial in question is not currently looking for new participants, as indicated by the clinicaltrials.gov website. Originally posted on December 12th, 2017 with a most recent edit taking place September 3rd, 2022; 3603 other trials are actively recruiting patients."

Answered by AI

What are the main goals of this clinical trial?

"The primary objective of this trial is to assess progression-free survival (PFS) in patients receiving radiation therapy (RT). Secondary objectives include locoregional failure (LRF), change in quality of life (QOL), and distant metastasis (DM)."

Answered by AI

Who else is applying?

What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am looking for alternatives to high dose radiation treatment.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
2018. "Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03258554.
All > Head And Neck Cancer
~28 spots leftby Apr 2025
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