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Monoclonal Antibodies

Cetuximab After Immunotherapy for Head and Neck Cancer

Phase 2
Recruiting
Led By Mercedes Porosnicu, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma
Must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will study if Cetuximab is an effective treatment for those who have failed or cannot tolerate other immuno-oncology treatments or immuno-oncology treatments combined with chemotherapy.

Who is the study for?
This trial is for adults with head and neck squamous cell carcinoma that has come back or spread after immunotherapy, possibly combined with chemo. They should be in a condition to perform daily activities (Performance Status 0-2), able to give blood and saliva samples, and agree to follow the study rules. Pregnant individuals, those who've had certain heart issues or lung diseases recently, or have had allergic reactions to similar drugs are not eligible.Check my eligibility
What is being tested?
The trial tests Cetuximab's effectiveness as a single agent in patients whose cancer didn't respond well to prior treatments involving PD-1 inhibitors. It's an open-label Phase II study where everyone knows they're getting Cetuximab; there’s no placebo group. Participants will also undergo quality of life assessments through questionnaires.See study design
What are the potential side effects?
Cetuximab can cause skin reactions like acneiform rash, itching, nail changes; allergic reactions including anaphylaxis; low magnesium levels; and rarely pulmonary toxicity. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as squamous cell carcinoma in the head or neck.
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I have been treated with immunotherapy targeting PD-1, alone or with chemotherapy.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Change in Overall Response Rate To Treatment with Cetuximab
Secondary outcome measures
Duration of Overall Survival
Duration of Progression Free Survival
Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956
43%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Neutropenia
28%
Vomiting
26%
Decreased Appetite
22%
Pyrexia
19%
Acne
19%
Hyponatremia
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Fatigue
15%
Pruritus
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Dizziness
9%
Cough
9%
White Blood Cell Count Decreased
7%
Hypochloremia
7%
Hypocalcaemia
7%
Dermatitis Acneiform
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Oral Pain
6%
Neck pain
6%
Dyspnoea
6%
Headache
3%
Anaphylactic reaction
1%
Pulmonary embolism
1%
Pneumonitis
1%
Staphylococcal skin infection
1%
Respiratory alkalosis
1%
Tumor hemorrhage
1%
Electrolyte imbalance
1%
Microcytic anemia
1%
Mouth hemorrhage
1%
Myocardial infarction
1%
Pneumonia
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

1Treatment groups
Experimental Treatment
Group I: CetuximabExperimental Treatment3 Interventions
Patients receive cetuximab IV over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,966 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,317 Total Patients Enrolled
Mercedes Porosnicu, MDPrincipal InvestigatorWake Forest University Health Sciences
5 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04375384 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Cetuximab
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04375384 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375384 — Phase 2

Frequently Asked Questions

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

Has Cetuximab been given the green light from the Food and Drug Administration?

"Our safety score for cetuximab is a 2 due to its Phase 2 trial status, meaning that there have been studies conducted which back the compound's security but none proving its efficacy."

Answered by AI

Has Cetuximab been previously explored in prior research?

"At present, there are 122 Cetuximab-related clinical trials in operation. Of those in progress, 30 have reached the Phase 3 stage. Dresden, Arizona is the primary hub for these studies; however, there exists a total of 5560 sites running tests with this medication worldwide."

Answered by AI

To what extent is Cetuximab employed to treat medical conditions?

"Cetuximab is frequently prescribed for pharmacotherapy, and it has been known to effectively combat regionally advanced squamous cell carcinoma of the head and neck, metastatic squamous cell carcinoma of the head and neck (hnscc), as well as squamous cell carcinoma."

Answered by AI

How many people have been recruited to participate in this experiment?

"Affirmative. The details found on clinicaltrials.gov show that this trial is currently seeking participants, having initially been posted on July 1st 2020 and last edited on August 5th 2022. Approximately 30 patients are being accepted by one medical facility."

Answered by AI

Is there currently an opportunity to join this medical experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, initially listed on July 1st 2020, is actively seeking patients. Approximately 30 individuals are needed to be recruited from one medical site."

Answered by AI
~6 spots leftby Mar 2025