Overview

This trial is active, not recruiting.

Condition carcinoma, squamous cell of head and neck
Treatments cetugex™, cetuximab, combination of cisplatin and 5-fluorouracil
Phase phase 2
Target EGFR
Sponsor Glycotope GmbH
Start date January 2014
End date July 2017
Trial size 240 participants
Trial identifier NCT02052960, GEXMab52201

Summary

The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
60 mg/day 0, 930 mg/day 1, followed by 720 mg weekly administration
cetugex™
combination of cisplatin and 5-fluorouracil
Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)
(Active Comparator)
400 mg/m2 on day 1, followed by 250 mg/m2 weekly administration
cetuximab
combination of cisplatin and 5-fluorouracil
Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

Primary Outcomes

Measure
To evaluate the efficacy of CetuGEX™ in terms of progression-free survival
time frame: up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients with histologically confirmed recurrent and/or metastatic EGFR-positive SCCHN not eligible for local treatment. 2. Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 3. Patients aged at least 18 years at screening. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Minimum life expectancy of 3 months. 6. Tissue samples available for specific disease and therapy related biological assessments. 7. If female and of childbearing potential, is non-lactating and has negative pregnancy test results at screening and prior to randomization. 8. If female, is either not of childbearing potential or using highly effective contraceptives. 9. Willing and able to comply with the protocol. 10. Willing and able to provide written informed consent. Exclusion Criteria: 1. Prior systemic chemotherapy (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening). 2. Cetuximab or other EGFR targeting agent treatment (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening). 3. Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization. 4. Concomitant anti-tumor therapy or concomitant immunotherapy. 5. Concomitant corticosteroid treatment unless specified within the protocol. 6. Clinical evidence of brain metastasis or leptomeningeal involvement. 7. Patients with nasopharyngeal tumors. 8. Concomitant malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g., basal cell cancer of the skin, cervical cancer or breast cancer in situ). Patients with other previous malignancies but without evidence of disease for at least 5 years will be allowed to enter the study. 9. Patients with renal or hepatic impairment. 10. Clinically active infections ≥ Grade 2 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 and/or requiring intravenous antibiotics. 11. Known active hepatitis B or C. 12. Known human immunodeficiency virus (HIV) infection. 13. Myocardial infarction within 6 months prior to screening. 14. Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening. 15. History of keratitis requiring medical interventions within the last 5 years. 16. Patients with any other disorder that, in the opinion of the investigator, might interfere with the conduct of the study. 17. Patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol. 18. Patients institutionalized by official means or court order. 19. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous CetuGEX™ administration. 20. Prior allergic reaction to a monoclonal antibody, grade 3 infusion related reaction (IRR) or any grade 4 reaction to a monoclonal antibody. 21. Known sensitivity to any component of the investigational medicinal product (IMP) and medication used in this study.

Additional Information

Official title Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus Chemotherapy in Comparison to Cetuximab Plus Chemotherapy for the Treatment of Patients With Stage III/IV Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Principal investigator Ulrich Keilholz, Prof
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Glycotope GmbH.