Extracranial primary germ cell cancer, seminoma, or nonseminoma. MedDRA version: 20.0 Level: PT Classification code 10061378 Term: Testicular germ cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10039956 Term: Seminoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10029557 Term
Conditions
Interventions
Product Name: avelumab
Product Code: MSB0010718C
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: AVELUMAB
CAS Number: 1537032-82-8
Current Sponsor code: MSB0010718C
Concentration unit:
Sponsors
Národný onkologický ústav
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent 2) Men aged 18 years or older 3) ECOG performance status: 0-1 4) Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma 5) Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer 6) Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy 7) Primary mediastinal GCTs in first relapse 8) Patient’s disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator, 9) RECIST 1.1 Measurable disease 10) Adequate hematologic function defined by ANC = 1500/mm3, platelet count = 100 000/mm3 and hemoglobin level = 9g/dl. 11) Adequate liver function defined by a total bilirubin level = 1.5 ULN, and ALT, AST = 2.5 × ULN . or AST and ALT levels = 5 x ULN (for subjects with documented metastatic disease to the liver). 12) Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance = 30 ml/min. Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)] 13) At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry, 14) At least 4 weeks must have elapsed since the last major surgery 15) Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1, 16) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 17) Highly effective contraception for both male and female subjects if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 30 days after avelumab treatment. 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 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: 1) Patients who do not fit inclusion criteria 2) Other prior malignancy except successfully treated non-melanoma skin cancer 3) No prior PD-1/PD-L1 inhibitor 4) Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy 5) Female patients 6) Patients infected by the Human Immunodeficiency Virus (HIV) 7) Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (1 NCI-CTCAE v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy (as measured by 12-week progression-free survival) of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors.;Secondary Objective: To describe the favorable response rate, time to progression and toxic effects of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs).;Primary end point(s): 12-week progression-free survival rate;Timepoint(s) of evaluation of this end point: after 15 subjects are enrolled, if results are favourable, after LVLP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate Median overall survival Median progression-free survival Toxicity Frequency of grade III and IV adverse events Association between clinical outcome and biomarkers ;Timepoint(s) of evaluation of this end point: after 15 patients are enrolled, if results are favourable, after LVLP | — |
Countries
Slovakia
Contacts
Public ContactJozef Valocký
Národný onkologický ústav
Outcome results
None listed