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Treatment Study for Patients with Cetuximab-Resistant Advanced Head and Neck Cancer

Clinical Trial Title: 
Phase II HNSCC study using CDX-3379 in combination with cetuximab in patients with cetuximab-resistant advanced HNSCC.
Clinical Trial Protocol ID: 
18010803
Clinical Trial Investigator Name: 
Mary Jo Fidler, MD
Clinical Trial Protocol Description: 

Study for CDX-3379 in combination with cetuximab for subjects with cetuximab resistant head and neck cancer and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have histologically or cytologically confirmed HNSCC that is recurrent or metastatic, not curable with local treatment modalities (e.g., surgery, radiation), and progressive (based on radiographic, clinical or pathologic assessment) during or subsequent to last therapy.
  • For patients with oropharyngeal cancers: Human papilloma virus (HPV) negative tumor, as established by the local site. Acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV deoxyribonucleic acid (DNA).
  • Have had prior treatment that included the following (in any combination or sequence):
    • Check-point inhibitor targeting PD-1, unless not a candidate
    • Cetuximab, with tumor progression during or within 6 months after completing treatment (regardless of any intervening therapies)
  • Have measurable (target) disease by RECIST 1.1 criteria. Target lesions selected for tumor measurements should be those where additional (e.g., palliative) treatments are not indicated or anticipated.

You will be excluded from the study if any of the following criteria apply to you:

  • Have nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
  • Have received CDX-3379 or other anti-ErbB3 targeted agents previously. 
  • Have any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  • Have 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 that has/have undergone curative surgery or radiation.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Head and Neck Cancer
Contact Phone: 
(312) 942-5183
Contact Name: 
Steffi Leung