Stage IV melanoma with no evidence of disease after surgery or radiotherapy MedDRA version: 21.1 Level: PT Classification code 10025650 Term: Malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: YERVOY
Product Name: Ipilimumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Concentration unit: mg/ml milligram(s)/mi
Sponsors
University of Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study only if they meet all the following criteria: 1. Stage IV melanoma arising from a primary cutaneous site or metastatic from an unknown primary site with no evidence of disease (NED) after surgery or radiation therapy (conducted within 8 weeks before enrolment) 2. Signed written informed consent 3. Men and women, aged 18 to 80 years 4. Known BRAF status 5. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study 6. Minimum life expectancy of five years excluding their melanoma diagnosis 7. ECOG performance status of or 1 8. Tumor tissue from the resected site of disease must be provided for biomarker analyses. In order to be randomized a subject must have a PD-L 1 expression classification (positive (= 5% tumor cells expressing PD-L1) or negative (=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons: 1. History of primary uveal or mucosal melanoma 2. Prior therapy with CTLA4 or PD1 antibodies 3. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. 4. Lack of availability for clinical follow-up assessments. 5. Any immunosuppressive therapy given within the past 30 days prior to study drug administration (excluding physiologic steroid hormone replacement) 6. Other malignancies within the past five years requiring treatment except basal or squamous skin carcinomas or carcinoma in situ of the cervix 7. Serious cardiac, gastrointestinal, hepatic or pulmonary disease reducing life expectancy to less than five years 8. Patients with serious intercurrent illness, requiring hospitalization. 9. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders. 10. The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV).or has another confirmed or suspected immunosuppressive or immunodeficient condition. 11. Known hypersensitivity reaction to any of the components of study treatment 12. Pregnancy (absence to be confirmed by ß-HCG serum test, minimum sensitivity 25IU/L or equivalent units of HCG)) or lactation period 13. Women of childbearing potential (WOCBP): Refusal or inability to use effective means of contraception (Pearl-Index <1). WOCBP receiving Nivolumab will be instructed to adhere to contraception until 31 weeks after the last dose of investigational product 14. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (Pearl-Index <1). Men receiving Nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception until 31 weeks after the last dose of investigational product 15. Known alcohol or drug abuse 16. Participation in another clinical study and use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days before registration 17. Significant disease or condition which, in the investigator’s opinion, would exclude the patient from the study 18. Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to estimate the efficacy of adjuvant immunotherapy with Nivolumab alone or in combination with Ipilimumab therapy in stage IV melanoma patients i.e. the primary endpoint is recurrence-free survival (RFS). ;Secondary Objective: - Overall survival (OS) - Time to recurrence (TTR) - Progression/recurrence free survival 2 (PRFS2) for crossover patients of Arm C - Safety / toxicity, i.e. all adverse events = Grade 3 according to CTCAE Version 4.0 criteria, that are related to the administration of the investigational agents will be assessed ;Primary end point(s): The primary endpoint is recurrence-free survival (RFS);Timepoint(s) of evaluation of this end point: Study enrolment until day of progression/death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival (OS) - Time to recurrence (TTR) - Progression/recurrence free survival 2 (PRFS2) for crossover patients of Arm C - Safety / toxicity, i.e. all adverse events = Grade 3 according to CTCAE Version 4.0 criteria, that are related to the administration of the investigational agents will be assessed;Timepoint(s) of evaluation of this end point: Study enrolment until death/end of study | — |
Countries
Austria, Germany
Contacts
Public ContactDepartement of Dermatology
University Hospital Essen
Outcome results
None listed