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CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer (RESGEX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glycotope GmbH
ClinicalTrials.gov Identifier:
NCT02052960
First received: January 27, 2014
Last updated: July 25, 2017
Last verified: July 2017
  Purpose
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).

Condition Intervention Phase
Carcinoma, Squamous Cell of Head and Neck Drug: Tomuzotuximab Drug: Cetuximab Drug: Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN

Resource links provided by NLM:


Further study details as provided by Glycotope GmbH:

Primary Outcome Measures:
  • Efficacy of CetuGEX™ (Tomuzotuximab) as compared to Cetuximab in terms of progression-free survival [ Time Frame: up to 24 months ]
    The primary objective 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 PFS


Enrollment: 240
Study Start Date: January 2014
Estimated Study Completion Date: December 15, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tomuzotuximab plus chemotherapy
60 mg/day 0, 930 mg/day 1, followed by 720 mg weekly administration
Drug: Tomuzotuximab
720 mg i.v. weekly
Other Name: CetuGEX™
Drug: Chemotherapy
Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)
Other Name: Combination of Cisplatin and 5-Fluorouracil
Active Comparator: Cetuximab plus chemotherapy
400 mg/m2 on day 1, followed by 250 mg/m2 weekly administration
Drug: Cetuximab
250 mg/sqm BSA i.v. weekly
Other Name: Erbitux®
Drug: Chemotherapy
Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)
Other Name: Combination of Cisplatin and 5-Fluorouracil

Detailed Description:

Indication: First line systemic treatment for stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Primary Objective:

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).

Secondary Objectives:

To evaluate further efficacy criteria, safety and quality of life (QoL) of patients with stage III/IV recurrent and/or metastatic SCCHN treated with CetuGEX™ as compared to cetuximab (both in combination with platinum-based chemotherapy).

To assess pharmacokinetic (PK) parameters and profiles of CetuGEX™. To assess efficacy and safety based on genetic markers for immune response (Fc-gamma receptor [FcγR] allotypes) and biomarkers.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052960

Locations
Belgium
Investigator
Antwerp, Belgium, 2650
Investigator
Brussels, Belgium, 1000
Investigator
Brussels, Belgium, 1200
Investigator
Gent, Belgium, 9000
France
Investigator
Avignon, France, 84918
Investigator
Lille, France, 59020
Investigator
Lyon, France, 69008
Investigator
Nice, France, 06189
Investigator
St Herblain, France, 44805
Germany
Investigator
Aachen, Germany, 52074
Investigator
Berlin, Germany, 12203
Investigator
Dresden, Germany, 01307
Investigator
Essen, Germany, 45122
Investigator
Hamburg, Germany, 20246
Investigator
Hannover, Germany, 30625
Investigator
Leipzig, Germany, 04103
Italy
Investigator
Milan, Italy, 20142
Investigator
Pavia, Italy, 27100
Poland
Investigator
Bydgoszcz, Poland, 85-796
Investigator
Krakow, Poland
Investigator
Lodz, Poland, 93-513
Investigator
Lublin, Poland, 20-090
Investigator
Warsaw, Poland, 2781
Romania
Investigator
Brasov, Romania, 500091
Investigator
Clui-Napoca, Romania, 400015
Investigator
Cluj-Napoca, Romania, 400015
Investigator
Craiova, Romania, 200385
Investigator
Oradea, Romania, 410469
Investigator
Ploiesti, Romania, 100011
Investigator
Timisoara, Romania, 300167
Investigator
Timisoara, Romania, 300239
Spain
Investigator
Barcelona, Spain, 08036
Investigator
Madrid, Spain, 28050
Investigator
Madrid, Spain, 28911
Investigator
Valencia, Spain, 46009
Sponsors and Collaborators
Glycotope GmbH
Investigators
Principal Investigator: Ulrich Keilholz, Prof Charite University, Berlin, Germany
  More Information

Responsible Party: Glycotope GmbH
ClinicalTrials.gov Identifier: NCT02052960     History of Changes
Other Study ID Numbers: GEXMab52201
Study First Received: January 27, 2014
Last Updated: July 25, 2017

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Cetuximab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017