Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse. MedDRA version: 20.0 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10040891 Term: Skin melanoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Opdivo(TM)
Product Name: Nivolumab- CLINICAL
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Nivolumab
CAS Number: 946414-94-4
Current Sponsor co
NIVOLUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the
MDX-010
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the pl
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: _Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study; _Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work; _No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions). Are the trial subjects under 18? yes Number of subjects for this age range: 13 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2426 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 857
Exclusion criteria
Exclusion criteria: _History of ocular/uveal melanoma; _; _Patients with active, known or suspected autoimmune disease; _Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy, as measured by recurrence-free survival (RFS), provided by nivolumab plus ipilimumab versus nivolumab monotherapy in participants with completely resected stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma. (in all randomized participants with PD-L1 expression level < 1%. and all randomized participants) ;Secondary Objective: _To compare the overall survival provided by nivolumab plus ipilimumab versus nivolumab monotherapy in participants with completely resected stage IIIb/c/d or stage IV NED melanoma. _To evaluate the association between PD-L1 expression and RFS. (in all randomized participants with PD-L1 expression level < 1%. and all randomized participants) _To evaluate investigator-assessed outcomes on next-line therapies;Primary end point(s): Recurrence-free survival (RFS).;Timepoint(s) of evaluation of this end point: Approximately 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): _Overall Survival (OS); _PD-L1 expression; _Objective response rates (if applicable) _Duration of treatment on next-line therapies _PFS2 defined as time from randomization to second recurrence/objective disease progression, or death from any cause, whichever occurs first. _End-of-next-line-treatment: To be used for situations where PFS2 cannot be reliably determined. ;Timepoint(s) of evaluation of this end point: _Up to 5 years for OS; _Approximately 3 years for PD-L1 expression. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Romania, Russian Federation, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed