A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03254927|
Recruitment Status : Active, not recruiting
First Posted : August 21, 2017
Last Update Posted : November 4, 2020
|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)|
|Actual Enrollment :||30 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|
|Actual Primary Completion Date :||September 16, 2020|
|Estimated Study Completion Date :||August 2021|
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.
- Clinical Benefit Response (CBR) [ Time Frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years ]The percentage of patients who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months
- Duration of response (DOR) [ Time Frame: First occurrence of a documented objective response to disease progression or death (up to approximately 2 years) ]The interval from which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) until the first date that progressive disease is objectively documented
- Progression-free Survival (PFS) [ Time Frame: From first dose to the first occurrence of disease progression or death due to any cause (up to approximately 2 years) ]The time from start of study drug to time of progression or death, whichever occurs first
- Overall Survival (OS) [ Time Frame: The time from start of study drug to death from any cause (up to approximately 2 years) ]The time from start of study drug to death
- 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 vital sign measurements, clinical laboratory tests, physical exams, ECGs and the incidence and severity of adverse events.
- Pharmacokinetic evalution [ Time Frame: From start of study drug through 30 day follow up ]CDX-3379 serum concentration will be measured
- Immunogenicity evaulation [ Time Frame: Prior to each dose of study treatment through 30 day follow up ]Serum samples will be obtained for assessment of human anti-CDX-3379 antibodies
- 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
|United States, Arizona|
|The University of Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06511|
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Rush University Medical center|
|Chicago, Illinois, United States, 60612|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|United States, Pennsylvania|
|University of Pennsylvania Hospital, Abramson Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|UPMC Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|