Status:
TERMINATED
A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Celldex Therapeutics
Conditions:
Advanced Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 squ...
Detailed Description
CDX-3379 is a fully human monoclonal antibody that binds to a molecule called human epidermal growth factor receptor 3 (HER3 or ErbB3) found on certain cells and may act to promote anti-tumor effects....
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed head and neck squamous cell carcinoma.
- Human papilloma virus (HPV) negative tumor.
- Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate.
- Prior treatment with cetuximab with tumor progression during or within 6 months after completing treatment.
- Measurable disease.
- Life expectancy ≥ 12 weeks.
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment.
- Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).
Exclusion
- Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
- Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
- Major surgery within 4 weeks prior to first dose of study treatment.
- Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
- Other prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast.
- Active, untreated central nervous system metastases.
- Active autoimmune disease or documented history of autoimmune disease.
- Significant cardiovascular disease including CHF or poorly controlled hypertension.
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03254927
Start Date
March 27 2018
End Date
December 16 2020
Last Update
April 3 2023
Active Locations (10)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Yale Cancer Center
New Haven, Connecticut, United States, 06511
3
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
4
Rush University Medical center
Chicago, Illinois, United States, 60612