NCT03254927|TerminatedPhase 2ResultsFDA Drug
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Sponsor decision based on emerging risk-benefit profile
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
Sponsor study identifier
interventional
30
1 country
10
Study Start
March 27, 2018
Actual (reported)Primary Completion
September 16, 2020
Actual (reported)Study Completion
December 16, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2017
Actual (reported)August 21, 2017
Actual (reported)March 27, 2018
Actual (reported)September 16, 2020
Actual (reported)December 16, 2020
Actual (reported)April 3, 2023
Actual (reported)Objective Response Rate
The percentage of patients who achieve a complete response or partial response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
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.
Clinical Benefit Response (CBR)
Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years
Duration of Response (DOR)
First occurrence of a documented objective response to disease progression or death (up to approximately 2 years)
Progression-free Survival (PFS)
From first dose to the first occurrence of disease progression or death due to any cause (up to approximately 2 years)
Overall Survival (OS)
The time from start of study drug to death from any cause (up to approximately 2 years)
Incidence of Adverse Events [Safety and Tolerability]
Following at least one dose of study treatment through 30 days after last dose of CDX-3379.
During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Yale Cancer Center
New Haven, Connecticut, 06511, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Rush University Medical center
Chicago, Illinois, 60612, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University of Pennsylvania Hospital, Abramson Cancer Center
Duvvuri U, George J, Kim S, Alvarado D, Neumeister VM, Chenna A, Gedrich R, Hawthorne T, LaVallee T, Grandis JR, Bauman JE. Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients. Clin Cancer Res. 2019 Oct 1;25(19):5752-5758. doi: 10.1158/1078-0432.CCR-18-3453. Epub 2019 Jul 15.
Study was terminated early due to unfavorable risk/benefit profile.
30 participants (actual enrollment reported by the registry).
First Submitted
August 17, 2017
First Posted
August 21, 2017
Study Start
March 27, 2018
Actual (reported)Primary Completion
Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer
Contact the study team to confirm eligibility.
Philadelphia, Pennsylvania, 19104, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
September 16, 2020
Actual (reported)Study Completion
December 16, 2020
Actual (reported)Last Updated
April 3, 2023
Results First Posted
April 3, 2023
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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