← Back to Search

Monoclonal Antibodies

Cetuximab for Head and Neck Squamous Cell Carcinoma

Phase 1
Waitlist Available
Led By Lara Dunn, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is testing the safety of using lenvatinib and cetuximab together to treat patients with head and neck or skin cancers. Lenvatinib blocks proteins that help cancer grow, while cetuximab attaches to cancer cells to stop their growth. The goal is to find out if this combination is safe and effective for these patients.

Eligible Conditions
  • Head and Neck Cancers
  • Head and Neck Squamous Cell Carcinoma
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Hyponatremia
19%
Acne
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Pruritus
15%
Fatigue
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%
Dermatitis Acneiform
7%
Hypocalcaemia
7%
Hypochloremia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Dyspnoea
6%
Neck pain
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Microcytic anemia
1%
Mouth hemorrhage
1%
Pneumonia
1%
Electrolyte imbalance
1%
Myocardial infarction
1%
Pneumonitis
1%
Pulmonary embolism
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Respiratory alkalosis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Head and Neck Squamous or Cutaneous Squamous Cell CarcinomaExperimental Treatment2 Interventions
A 3+3 dose de-escalation design for three dose levels of lenvatinib combined with cetuximab will be used. A DLT will be defined as any toxicities of grade 3 or higher (per CTCAE v4 criteria) felt to be possibly, probably, or definitely related to lenvatinib, as well as grade 4 toxcities related to cetuximab, which occurs within 28 days following the first dose of lenvatinib in combination with cetuximab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Cetuximab
FDA approved

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,965 Previous Clinical Trials
596,959 Total Patients Enrolled
Lara Dunn, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
45 Total Patients Enrolled
~3 spots leftby Nov 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