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

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ClinicalTrials.gov Identifier: NCT03254927
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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 squamous cell carcinoma who have previously received cetuximab and progressed.

Condition or disease Intervention/treatment Phase
Advanced Head and Neck Squamous Cell Carcinoma Drug: CDX-3379 and cetuximab Phase 2

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.

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CDX-3379 and cetuximab
During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.
Drug: CDX-3379 and cetuximab
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.


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
    The percentage of patients who achieve a complete response or partial response per RECIST 1.1 criteria.

  2. Incidence of drug related adverse events, serious drug related adverse events, dose-limiting toxicities and laboratory test abnormalities [Safety and Tolerability] [ Time Frame: Following at least one dose of study treatment through 30 days after last dose of CDX-3379. ]
    Safety and tolerability of CDX-3379 in combination with cetuximab as determined by drug related adverse events, serious drug related adverse events, dose-limiting toxicities and laboratory test abnormalities.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254927


Contacts
Contact: Celldex Therapeutics 844-723-9363 info@celldex.com

Locations
United States, Arizona
University of Arizona Cancer Center Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Julie Bauman, MD         
United States, Georgia
Emory University Winship Cancer Institute Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Nabil Saba, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Douglas Adkins, MD       dadkins@wustl.edu   
Principal Investigator: Douglas Adkins, MD         
United States, Pennsylvania
University of Pennsylvania Hospital, Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Volpe       mailto:melissa.Volpe@uphs.upenn.edu   
Principal Investigator: Roger Cohen, MD         
Sponsors and Collaborators
Celldex Therapeutics
More Information

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT03254927     History of Changes
Other Study ID Numbers: CDX3379-04
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celldex Therapeutics:
Erbitux

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents