Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
Inclusion Criteria:1. Histologically confirmed diagnosis of stage II (AJCCv8) melanoma arising from a primary cutaneous site after surgery therapy 2. Sentinel node biopsy (SNB) without detection of melanoma deposits 3. Randomization not later than 12 weeks after SNB procedure 4. Tumor tissue from primary tumor must be provided for biomarker analyses. In order to be randomized, a subject must be classified by MelaGenix risk analysis. 5. Men and women at the age of 18 to 80 years 6. Signed written, informed consent 7. Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study 8. Minimum life expectancy of five years excluding their melanoma diagnosis 9. ECOG performance status of 0-1 10. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:
- - White blood cells (WBC) ≥ 2000/μL - Neutrophils ≥ 1500/μL - Platelets ≥ 100 x103/μL - Hemoglobin ≥ 9.0 g/dL - Serum creatinine ≤ 1.5xUL - Creatinine clearance (CrCl) ≥ 40mL/min (using the Cockcroft-Gault formula) - AST / ALT ≤ 3 x ULN - Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dL) 11.
Exclusion Criteria:1. History of primary uveal or mucosal melanoma 2. No access to sufficient tumor tissue of primary tumor 3. SNB procedure > 12 weeks before randomization 4. Prior active malignancy within the previous 3 years except for locally curable cancers that have been apparently cured, such as: basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, or breast. 5. Prior or planned therapy with Interferon alpha, CTLA4 or PD-1 / PD L1 antibodies 6. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment 7. Administration of live vaccines within 4 weeks before start of study therapy 8. Any immunosuppressive therapy given within the past 30 days 9. Active psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures 10. Active immune deficiencies or significant autoimmune disease 11. Serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to less than five years 12. Serious intercurrent illness, requiring hospitalization 13. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders 14. The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other active chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition 15. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. 16. Hypersensitivity to the active substance or to any of the excipients 17. Participation in another clinical study within the 30 days before registration 18. For female patients: Pregnancy or breast-feeding 19. For WOCBP and male patients with partners of childbearing potential: Refusal or inability to use effective means of contraception 20. Lack of availability for clinical follow-up assessments 21. Legal incapacity or limited legal capacity
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Essen|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Dirk Schadendorf, Prof. Dr.|
|Principal Investigator Affiliation||University Hospital, Essen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Malignant Melanoma Stage II|
The NivoMela trial is a randomized, controlled, prospective, multi-center national phase III trial with biomarker-based risk stratification. Stage II melanoma patients having undergone surgery of the malignant melanoma will be screened using the MelaGenix GEP score to identify patients at high risk for relapse. It is expected, that 61% of screened patients will belong to this group. Patients with a risk score of > 0.0 (HR 1.48, 1.11-1.98) corresponding to high risk of relapse will be randomized at a ratio of 2:1 to receive either nivolumab as adjuvant treatment (arm A) or observation only (arm B). Stratification factors for randomization are: 1. Tumor stage: IIA versus IIB versus IIC 2. Gender: Female versus Male 3. Site of primary tumor: extremities versus trunk versus head &neck All screened patients with a risk score of ≤ 0.0 who are not eligible for randomization will be followed for RFS, DMFS and OS for at least 5 years according to German Follow-up guidelines (Arm C). Various factors that could potentially predict clinical response and incidence of AEs to treatment with nivolumab will be investigated in peripheral blood and tumor specimen taken at baseline. Data from these investigations will be evaluated for associations with clinical efficacy (eg, ORR, PFS, OS) and safety/toxicity (AE). The samples may also be used for exploratory analyses to assess biomarkers associated with melanoma and/or with immunotherapy treatment.
Experimental: Nivolumab (Arm A)
Patients with a risk score of > 0.0 corresponding to high risk of relapse (randomized): Nivolumab will be applied at a flat dose of 480 mg given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year. Afterwards these patients will receive intense clinical follow up according German Follow up guidelines.
No Intervention: Observation, High Risk (Arm B)
Patients with a risk score of > 0.0 corresponding to high risk of relapse (randomized): Control group (observation only). These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines.
No Intervention: Observation, Low Risk (Arm C)
Patients with a risk score of ≤ 0.0 corresponding to low risk of relapse who are not eligible for randomization: These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines. Documentation of clinical outcome of these patients.
Drug: - Nivolumab
480 mg nivolumab fixed dose given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.