A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma
Condition: Advanced Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: CDX-3379 and cetuximab
Intervention description: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erbitux; Cetuximab; Oral Cancer; Oropharyngeal cancer; Laryngeal cancer; Head and Neck Squamous Cell Carcinoma

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed head and neck squamous cell carcinoma.

          2. Human papilloma virus (HPV) negative tumor.

          3. Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate.

          4. Prior treatment with cetuximab with tumor progression during or within 6 months after
             completing treatment.

          5. Measurable disease.

          6. Life expectancy ≥ 12 weeks.

          7. 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.

          8. Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not
             feasible, provide archival tissue).

        Exclusion Criteria:

          1. Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.

          2. Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II
             (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.

          3. Major surgery within 4 weeks prior to first dose of study treatment.

          4. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to
             first dose of study treatment.

          5. Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other
             immunotherapy within 2 weeks prior to first dose of study treatment.

          6. 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.

          7. Active, untreated central nervous system metastases.

          8. Active autoimmune disease or documented history of autoimmune disease.

          9. Significant cardiovascular disease including CHF or poorly controlled hypertension.