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Monoclonal Antibodies

CDX-3379 and cetuximab for Head and Neck Cancers

Phase 2
Waitlist Available
Research Sponsored by Celldex Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.

Eligible Conditions
  • Head and Neck Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate
Secondary study objectives
Clinical Benefit Response (CBR)
Duration of Response (DOR)
Incidence of Adverse Events [Safety and Tolerability]
+3 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Alkaline phosphatase increased
18%
Insomnia
18%
Non-cardiac chest pain
18%
Aspartate aminotransferase increased
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Arthralgia
10%
Dizziness
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Vertigo
3%
Oral pain
3%
Alopecia
3%
Tracheostomy site bleeding
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: CDX-3379 and cetuximabExperimental Treatment1 Intervention
During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.

Find a Location

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor
64 Previous Clinical Trials
5,772 Total Patients Enrolled
~4 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.
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