NCT02052960|CompletedPhase 2ResultsDMCFDA Drug

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

RESGEX

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

Glycotope GmbH ClinicalTrials.gov

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2 other identifiers

GEXMab522012013-000931-28

Study Type

interventional

Target

240

Locations

7 countries

Sites

Timeline

RegisteredFeb 2014

StartedFeb 2014

CompletionOct 2017

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

240

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach

7 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

First Submitted

Initial submission to the registry

January 27, 2014

Completed

5 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

November 2, 2021

Completed

Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

3.6 years

First QC Date

January 27, 2014

Results QC Date

July 12, 2021

Last Update Submit

October 4, 2021

Conditions

Carcinoma, Squamous Cell of Head and Neck

Keywords

tomuzotuximabcetuximabSCCHN

Outcome Measures

Primary Outcomes (1)

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.
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)
Time from randomization until disease progression or death, whichever occurs first, up to 24 month.
Clinical Benefit Rate
Time from randomization until disease progression or death, whichever occurs first, up to 24 month.
Time to Treatment Failure
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 from randomization to the time of death, up to 24 month.
Time of Global Health Status Deterioration
From randomization up to end-of study visit, up to 24 month

Study Arms (2)

CetuGEX™ plus chemotherapy

EXPERIMENTAL

720 mg weekly administration

Drug: CetuGEX™Drug: Chemotherapy

Cetuximab plus chemotherapy

ACTIVE COMPARATOR

250 mg/m2 weekly administration

Drug: CetuximabDrug: Chemotherapy

Interventions

CetuGEX™DRUG

60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration

Also known as: Tomuzotuximab

CetuGEX™ plus chemotherapy

CetuximabDRUG

400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration

Also known as: Erbitux®

Cetuximab plus chemotherapy

ChemotherapyDRUG

Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

Also known as: Combination of Cisplatin and 5-Fluorouracil

CetuGEX™ plus chemotherapyCetuximab plus chemotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.

You may not qualify if:

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.
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.
+7 more criteria

Contact the study team to confirm eligibility.