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 : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Head and Neck Squamous Cell Carcinoma||Drug: CDX-3379 and cetuximab||Phase 2|
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 45 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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.
- 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.
- Tumor DNA biomarkers. [ Time Frame: Tumor tissue is obtained during screening window via single biopsy procedure. ]Tumor DNA biomarkers will be evaluated and assessed for correlation with clinical efficacy.
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
|Contact: Celldex Therapeuticsfirstname.lastname@example.org|
|United States, Arizona|
|The University of Arizona Cancer Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Rachel Jarrett, MPH 520-626-0375 email@example.com|
|Contact: Ashley Hale 520-626-3199 firstname.lastname@example.org|
|Principal Investigator: Julie Bauman, MD, MPH|
|United States, Connecticut|
|Yale Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06511|
|Contact: Alexandra Minnella Alexandra.Minnella@yale.edu|
|Principal Investigator: Barbara Burtness, MD|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Nabil Saba, MD 404-778-1900|
|Contact: Dong Moon Shin, MD 404-778-1900|
|Principal Investigator: Nabil Saba, MD|
|United States, Illinois|
|Rush University Medical center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Aaron Munoz 312-563-8756 email@example.com|
|Contact: Steffi Leung, RN, MSN 312-942-5183 mailto:Steffi_Leung@rush.edu|
|Principal Investigator: Mary-Jo Fidler, MD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Douglas Adkins, MD firstname.lastname@example.org|
|Principal Investigator: Douglas Adkins, MD|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Alison Kastl 513-558-3545 email@example.com|
|Contact: Aubrey Steele 513-584-1492 firstname.lastname@example.org|
|Principal Investigator: Trisha Wise-Draper, 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|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Kelsey Mitch 412-623-6793 email@example.com|
|Contact: Carrie Muniz 412-623-6121 firstname.lastname@example.org|
|Principal Investigator: Umamaheswar Duvvuri, MD|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Brittanie Weinerman 843-792-6349 email@example.com|
|Contact: Kristina Godwin 843-792-8876 firstname.lastname@example.org|
|Principal Investigator: Paul O'Brien, MD|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Wendy Vermeulen 800-811-8480 Wendy.Vermeulen@vumc.org|
|Principal Investigator: Michael Gibson, MD, PhD|