Patients with histologically or cytologically confirmed AJCC (8th ed.) Stage IIIB -IV resectable melanoma. MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: OPDIVO
Product Code: [BMS-936558]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
Current Sponsor code: BMS-936558
Concentration unit: mg/ml mil
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have histologically or cytologically confirmed 8th ed. AJCC Stage IIIB/C/D or Stage IV oligometastatic resectable melanoma. Patients with cutaneous, mucosal, acral, ocular or unknown primary melanomas are eligible for enrollment. Oligometastatic melanoma is defined as three or fewer areas of resectable disease excluding central nervous system and bone involvement. In case of involvement of three areas, one must be superficial (cutaneous-subcutaneous). Resectable tumors are defined as having no significant vascular, neural or bony involvement. A multidisciplinary discussion within surgical oncologists, medical oncologists, and radiologist will assess if disease is resectable. · Signed Written Informed Consent. · Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and all protocol procedures. · Males and Females, ages =18 years of age. · Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 · Have measurable disease based on RECIST 1.1. · Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion at baseline and at the time points specified in the Study Procedure Tables. · Known BRAF V600 mutation status as determined by local institutional standard. All BRAF statuses (BRAF wild type or BRAF 600 mutation positive) are eligible. · Patients who have been previously treated in the adjuvant setting for melanoma will be eligible for treatment after a 28 day washout period. · Patients must be medically fit enough to undergo surgery as determined by the treating medical and surgical oncology team. · Demonstrate adequate organ function as defined below: Hematologic Absolute neutrophil count (ANC) >/= 1.5 X 10^9/L; Hemoglobin >/= 9.5 g/dL Platelets >/= 100 X 10^9/L PT/INR and PTT 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin /=2.5 g/dL Renal Creatinine OR Calculated creatinine clearance OR 24-hour urine creatinine clearance /= 50 mL/min >/= 50 mL/min. · Women are eligible to participate if: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: oncological therapies or other concomitant experimental oncologic treatments. B. Major surgery within the previous 3 weeks C. Cerebral, leptomeningee or bone metastases D. Pregnancy or lactation. E. Concomitant pathologies that increase, in the opinion of investigators, the risk associated with the Participation in the study, the administration of the treatment or interfering with the interprettazioen of Results F. Active oncological pathologies arising in the two years preceding enlistment except Pre-existing diagnosis of melanoma and treatable neoplasia and apparently treated with local therapies, G. Patients with autoimmune diseases known or suspected, with the exception of vitiligo, diabetes mellitus of type I, hypothyroidism resulting from autoimmune diseases and requiring substitution therapy, Psoriasis that does not require systemic therapy, or conditions that you expect a flare to Cause of external factors H. Corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or other treatment Immunosuppressants within 14 days of administration of treatment I. Topical or inhalatory steroids and replacement therapy for adrenal insufficiency with > 10 mg/day of prednisone or equivalents are allowed in the absence of an active autoimmune disease J. Previous anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of grade 3-4 AE rates (immune related or not) of neoadjuvant and adjuvant regimen and overall AE rates · Overall Response Rate (ORR), according to RECIST 1.1 criteria and overall pathological response rate · Overall Survival (OS) · Health related quality of life (HRQoL);Timepoint(s) of evaluation of this end point: every cycle/ end of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of efficacy in terms of pathological complete response rates;Secondary Objective: Feasibility and safety. Identification of outcome-related biomarkers;Primary end point(s): pathological complete response rates after surgery.;Timepoint(s) of evaluation of this end point: after surgery. | — |
Countries
Italy
Contacts
Public ContactUfficio Studi Clinici ed Attività R
Istituto Europeo di Oncologia
Outcome results
None listed