Recurrent/metastatic squamous cell cancer of the head and neck MedDRA version: 14.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 100000004864
Conditions
Interventions
Product Name: EMD 1201081
Product Code: EMD 1201081
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: EMD 1201081
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent prior to any trial-specific procedure. 2. Male or female, age = 18 years. 3. Histologically confirmed squamous cell carcinoma of the head and neck that is recurrent and/or metastatic; documented in the medical record. 4. History of progressing disease on a first-line cytotoxic chemotherapy regimen such as 5-FU + cisplatin, taxanes, etc. for their R/M SCCHN. (A history of chemotherapy/ radiation therapy for localized disease does not count as a first-line regimen.) 5. The subject is suited for systemic therapy in the opinion of the Investigator. 6. At least one radiographically documented lesion assessable according to RECIST 1.0. Lesions in previously irradiated areas should be measurable (i.e. the lesion must be adequately measurable in at least one dimension; longest diameter to be recorded as = 2 cm by conventional techniques or = 1 cm by spiral CT scan). If the sole site of measurable disease is in a prior radiation field, there must be unequivocal evidence of progression at = 8 weeks since the completion of radiation or a positive biopsy. 7. ECOG performance status of 0 or 1. 8. If female, either post-menopausal, surgically sterile, or having a negative urine or serum pregnancy test (ß-HCG) at screening and practicing medically accepted contraception. If male, practicing contraception if risk of conception exists. For relevant subjects, the duration of contraception should be 1 week prior to the start of therapy through 4 weeks after receipt of trial therapy. 9. Recovered from previous toxicities of prior cytotoxic regimen to CTCAE Grade 1 (with the exception of alopecia). 10. Hemoglobin = 9 g/dL (without transfusion support, no transfusion within 7 days of screening). 11. Neutrophils = 1.5 x 109/L. 12. Platelets = 100 x 109/L. 13. PT/PTT = 1.5 times the upper limit of normal for the site, unless there is therapeutic anti-coagulation (see below; INR values should be converted to PT for screening). 14. Serum creatinine = 1.5 times the upper limit of normal for the site. 15. ALT and AST = 3 times the upper limit of normal for the site. 16. Be willing and able to comply with the protocol procedures for the duration of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of prior exposure to cetuximab or panitumumab or any other approved or investigational anti-EGFR agents. 2. Undifferentiated nasopharyngeal carcinoma. 3. Chemotherapy, radiotherapy or any investigational agents within 4 weeks of first dose of trial medication. 4. Major surgical or planned procedure within 30 days prior to first dose of trial medication (isolated biopsies are not counted as major surgical procedures). 5. Other active malignancy besides non-metastatic basal cell or squamous cell carcinoma of the skin or second primary squamous cell carcinoma of the head and neck. 6. Impaired cardiac function (e.g. left ventricular ejection fraction 10 mg/day). 10. Pregnancy or breast feeding. 11. Legal incapacity or limited legal capacity. 12. Significant medical or psychiatric disease which makes the trial inappropriate for the subject in the Investigator’s opinion. 13. Any brain metastasis and/or leptomeningeal disease (known or suspected). 14. Significant pre-existing immune deficiency such as infection by HIV (documented or known). 15. Clinically significant ongoing infection. 16. Known hypersensitivity to the trial treatments. 17. Participation in another clinical trial within the past 30 days. 18. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. 19. Other significant disease that in the Investigator’s opinion would exclude the subject from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate progression-free survival time of subjects treated with EMD 1201081 + cetuximab compared to cetuximab alone in cetuximab-naïve subjects with recurrent and/or metastatic SCCHN who have progressed on a cytotoxic therapy.;Secondary Objective: • To evaluate the overall response (by RECIST 1.0) or disease control status (CR + PR + SD) of subjects treated with EMD 1201081 + cetuximab compared to cetuximab alone in subjects with R/M SCCHN. • To evaluate overall survival time in subjects treated with EMD 1201081 + cetuximab as second-line treatment. • To study the safety and tolerability of the combination EMD 1201081 + cetuximab in the overall trial population. ;Primary end point(s): Progression-free survival (PFS) time;Timepoint(s) of evaluation of this end point: Evaluation will be performed at baseline and every 6 weeks after randomization/start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the overall response (by RECIST 1.0) or disease control status (CR + PR + SD) of subjects treated with EMD 1201081 + cetuximab compared to cetuximab alone in subjects with R/M SCCHN.;Timepoint(s) of evaluation of this end point: The best overall response will be derived from the assessments of overall response at the individual time points | — |
Countries
Belgium, Croatia, Czech Republic, France, Hungary, Lithuania, Netherlands, Poland, Slovakia, United Kingdom, United States
Contacts
Public ContactCommunication Center Marck KGaA
Merck KGaA
Outcome results
None listed