Carcinoma, Squamous Cell of Head and NeckPhase 2RESGEXNCT02052960
CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer
A Phase 2 study testing CetuGEX™, Cetuximab and Chemotherapy in people with Carcinoma, Squamous Cell of Head and Neck, run by Glycotope GmbH at 34 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- CetuGEX™, Cetuximab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 34 sitesin 7 countries
- Study dates
- Feb 2014to 4 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed recurrent and/or metastatic SCCHN not eligible for local treatment.
- Patients with measurable disease according to RECIST 1.1.
- Patients aged at least 18 years at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Minimum life expectancy of 3 months.
- Tissue samples available for specific and therapy-related biological assessments.
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- If female and of childbearing potential, was non-lactating and had negative pregnancy test results at screening and prior to randomization.
- If female, was either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or willing to use highly effective contraceptives during study participation until 6 months after last administration of any study medication, particularly cisplatin or carboplatin, with a failure rate <1% according to the Note for Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency. Male patients who had partners of childbearing potential had to confirm adequate use of highly effective contraceptives during study participation until 6 months after last administration of any study medication, particularly cisplatin or carboplatin, as well.
- Willing and able to comply with the protocol.
- Willing and able to provide written informed consent.
Who cannot join
- 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 randomization.
- Cetuximab or other epidermal growth factor receptor (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 randomization.
- Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization.
- Concomitant antitumor therapy or concomitant immunotherapy, live vaccines including yellow fever vaccination (as per cisplatinum Summary of Product Characteristics [SmPC]).
- Concomitant corticosteroid treatment unless specified within the protocol.
- Clinical evidence of brain metastasis or leptomeningeal involvement.
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- Patients with nasopharyngeal tumors.
- 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 previous malignancies but without evidence of disease for at least 5 years were allowed to enter the study.
- Patients with renal or hepatic impairment (serum creatinine and bilirubin >1.5 fold above the upper limit of normal ranges, creatinine clearance <60 mL/min, and transaminase >5-fold above the upper limit of normal ranges) and patients with hematology parameters outside the normal ranges (hemoglobin <9 g/dL, absolute neutrophil count <1500/mm3 and platelet count <105/mm3) at screening as well as patients with impaired auditory function or platinum-related neuropathy.
- Clinically active infections ≥Grade 2 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 and/or requiring intravenous antibiotics.
- Known active hepatitis B or C.
- Known human immunodeficiency virus (HIV) infection.
- Myocardial infarction within 6 months prior to screening.
- Symptomatic congestive heart failure (New York Heart Association 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.
- History of keratitis requiring medical interventions within the last 5 years or interstitial lung disease.
- Patients with any other disorder that, in the opinion of the investigator, might have interfered with the conduct of the study.
- 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.
- Patients institutionalized by official means or court order.
- Receipt of any other IMP within the last 30 days before randomization or any previous CetuGEX™ administration.
- Prior allergic reaction to a monoclonal antibody, grade 3 infusion related reaction (IRR) or any grade 4 reaction to a monoclonal antibody.
- Known sensitivity to any component of the IMP and medication used in this study.
- Known dihydropyrimidine dehydrogenase deficiency (France only).
Trial locations and contacts
34 sites in 7 countries.
34 sites in 7 countries
Germany7 sites
Glycotope-contracted Research Facility
Aachen, 52074
Glycotope-contracted Research Facility
Berlin, 12203
Glycotope-contracted Research Facility
Dresden, 01307
Glycotope-contracted Research Facility
Essen, 45122
Glycotope-contracted Research Facility
Hamburg, 20246
Glycotope-contracted Research Facillity
Hanover, 30625
Glycotope-contracted Research Facility
Leipzig, 04103
Romania7 sites
Glycotope-contracted Research Facility
Brasov, 500091
Glycotope-contracted Research Facility
Clui-Napoca, 400015
Glycotope-contracted Research Facility
Craiova, 200385
Glycotope-contracted Research Facility
Oradea, 410469
Glycotope-contracted Research Facility
Ploieşti, 100011
Glycotope-contracted Research Facility
Timișoara, 300167
Glycotope-contracteed Research Facility
Timișoara, 300239
France5 sites
Glycotope-contracted Research Facility
Avignon, 84918
Glycotope-contracted Research Facility
Lille, 59020
Glycotope-contracted Research Facility
Lyon, 69008
Glycotope-contracted Research Facility
Nice, 06189
Glycotope-contracted Research Facility
Saint-Herblain, 44805
Poland5 sites
Glycotope-contracted Research Facility
Bydgoszcz, 85-796
Glycotope-contracted Research Facility
Krakow
Glycotope-contracted Research Facility
Lodz, 93-513
Glycotope-contracted Research Facility
Lublin, 20-090
Glycotope-contracted Research Facility
Warsaw, 2781
Belgium4 sites
Glycotope-contracted Research Facility
Antwerp, 2650
Glycotope-contracted Research Facility
Brussels, 1000
Glycotope-contracted Research Facility
Brussels, 1200
Glycotope-contracted Research Facility
Ghent, 9000
Spain4 sites
Glycotope-contracted Research Facility
Barcelona, 08036
Glycotope-contracted Research Facility
Madrid, 28050
Glycotope-contracted Research Facility
Madrid, 28911
Glycotope-contracted Research Facility
Valencia, 46009
Italy2 sites
Gycotope-contracted Research Facility
Milan, 20142
Glycotope-contracted Research Facility
Pavia, 27100
About this study
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
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).
Read the 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 (exploratory only).
- Being tested
- CetuGEX™, Cetuximab, Chemotherapy
- Keywords
- tomuzotuximab, cetuximab, SCCHN
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuGEX™Drug
Also called Tomuzotuximab
60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration
CetuximabDrug
Also called Erbitux®
400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration
ChemotherapyDrug
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| CetuGEX™ plus chemotherapy | Experimental | 720 mg weekly administration Receives: Drug: CetuGEX™; Drug: Chemotherapy |
| Cetuximab plus chemotherapy | Active comparator | 250 mg/m2 weekly administration Receives: Drug: Cetuximab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
The primary efficacy endpoint was PFS as assessed by the investigator. Date of disease progression was defined as the date of imaging (based on computed tomography (CT) scans or magnetic resonance imaging (MRI)) showing disease progression, as assessed by the investigator according to adapted immune-related RECIST 1.1 (modified irRC). Disease progression was defined as a 20% increase in tumor burden, taking as reference the smallest tumor burden recorded since the treatment started; confirmation by a second scan was not required. The PFS time was censored at the time of the last tumor assessment if the patient was alive and without progression at the last time of observation.
Measured: The PFS was defined as time from randomization until disease progression or death of any cause, up to 24 month
Secondary outcomes (5)
Objective Response Rate (ORR)
Objective response rate is the percentage of patients with a tumor size reduction of a predefined amount for a minimum time period and it is defined as the sum of complete responses (CR) and partial responses (PR).
CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).
PR: At least a 30% decrease in the tumor burden (sum of the longest lesion diameter (LD) of target lesions (including the short axes of any target lymph nodes plus measurable new lesions), taking as reference the baseline sum diameters.
Measured: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.
Clinical Benefit Rate
The clinical benefit rate is the percentage of patients with an objective response or stable disease (SD). SD is defined as not meeting criteria of complete response and partial response, in absence of meeting criteria for disease progression. Follow-up measurements must have met the SD criteria at least once after randomization at a minimum interval of 8 weeks.
Measured: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.
Time to Treatment Failure
Time to treatment failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
Measured: Time to treatment failure, defined as the interval between the date of randomization and the date of treatment discontinuation for any reason, up to 24 month.
Overall Survival
The overall survival is defined as the duration of time from randomization to the time of death.
Measured: Time from randomization to the time of death, up to 24 month.
Time of Global Health Status Deterioration
Quality of Life (QoL) scores as assessed by European Oncology Research Trials Committee (EORTC) QoL questionnaires (QLQ) EORTC-QLQ-C30.
Scores are on a scale of 0 to 100, where 100 represents the highest possible QoL.Time to first deterioration of at least 10 points.
Measured: From randomization up to end-of study visit, up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion28 Aug 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Squamous Cell of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycotope GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Keilholz, Prof, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052960
- Sponsor's protocol ID
- GEXMab52201
- Other IDs
- 2013-000931-28
- Acronym
- RESGEX
- Status last verified
- Oct 2021
- First submitted
- 27 Jan 2014
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02052960
- Acronym / sponsor ID
- RESGEX / GEXMab52201
- Keywords
- tomuzotuximab, cetuximab, SCCHN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Glycotope GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 (exploratory only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CetuGEX™ plus chemotherapy | Experimental | Drug: CetuGEX™, Drug: Chemotherapy720 mg weekly administration |
| Cetuximab plus chemotherapy | Active comparator | Drug: Cetuximab, Drug: Chemotherapy250 mg/m2 weekly administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed recurrent and/or metastatic SCCHN not eligible for local treatment.
- Patients with measurable disease according to RECIST 1.1.
- Patients aged at least 18 years at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Minimum life expectancy of 3 months.
Key exclusion criteria (22 listed)
- 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 randomization.
- Cetuximab or other epidermal growth factor receptor (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 randomization.
- Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization.
- Concomitant antitumor therapy or concomitant immunotherapy, live vaccines including yellow fever vaccination (as per cisplatinum Summary of Product Characteristics [SmPC]).
- Concomitant corticosteroid treatment unless specified within the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuGEX™Also: Tomuzotuximab60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration | Drug | CetuGEX™ plus chemotherapy |
| CetuximabAlso: Erbitux®400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration | Drug | Cetuximab plus chemotherapy |
| ChemotherapyAlso: Combination of Cisplatin and 5-FluorouracilCombination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity) | Drug | CetuGEX™ plus chemotherapy, Cetuximab plus chemotherapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: The PFS was defined as time from randomization until disease progression or death of any cause, up to 24 month
The primary efficacy endpoint was PFS as assessed by the investigator. Date of disease progression was defined as the date of imaging (based on computed tomography (CT) scans or magnetic resonance imaging (MRI)) showing disease progression, as assessed by the investigator according to adapted immune-related RECIST 1.1 (modified irRC). Disease progression was defined as a 20% increase in tumor burden, taking as reference the smallest tumor burden recorded since the treatment started; confirmation by a second scan was not required. The PFS time was censored at the time of the last tumor assessment if the patient was alive and without progression at the last time of observation.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.
Clinical Benefit Rate
Time frame: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.
Time to Treatment Failure
Time frame: Time to treatment failure, defined as the interval between the date of randomization and the date of treatment discontinuation for any reason, up to 24 month.
Overall Survival
Time frame: Time from randomization to the time of death, up to 24 month.
Time of Global Health Status Deterioration
Time frame: From randomization up to end-of study visit, up to 24 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Keilholz, Prof principal investigator
Charite University, Berlin, Germany
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CetuGEX™, Cetuximab and Chemotherapy in people with Carcinoma, Squamous Cell of Head and Neck, run by Glycotope GmbH at 34 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, Romania, France, Poland, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: The PFS was defined as time from randomization until disease progression or death of any cause, up to 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.