Clinical Trials /

A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

NCT03254927

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma
  • Official Title: A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: CDX3379-04
  • NCT ID: NCT03254927

Conditions

  • Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
CDX-3379 and cetuximabCDX-3379 and cetuximab

Purpose

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.

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.

      Cetuximab is a human monoclonal antibody that blocks EGFR, a protein receptor that regulates
      cell growth.

      This study will evaluate the safety, tolerability and efficacy of CDX-3379 in combination
      with cetuximab in patients with advanced head and neck squamous cell carcinoma who have
      previously received cetuximab and progressed.

      Eligible patients that enroll in the study will be given the dose of 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.

      Up to 30 patients will be enrolled. All patients enrolled in the study will be closely
      monitored to determine if there is a response to the treatment as well as for any side
      effects that may occur.
    

Trial Arms

NameTypeDescriptionInterventions
CDX-3379 and cetuximabExperimentalDuring the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.
  • CDX-3379 and cetuximab

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically or cytologically confirmed head and neck squamous cell carcinoma.

          2. Human papilloma virus (HPV) negative tumor for patients with oropharyngeal cancers.

          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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.
Safety Issue:
Description:The percentage of patients who achieve a complete response or partial response per RECIST 1.1 criteria.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celldex Therapeutics

Trial Keywords

  • Erbitux
  • Cetuximab
  • Oral Cancer
  • Oropharyngeal cancer
  • Laryngeal cancer
  • Head and Neck Squamous Cell Carcinoma

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