A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.
- Conditions
- 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: 20.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003729-41-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3296
_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
_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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>;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.<br>_To evaluate the association between PD-L1 expression and RFS.<br>(in all randomized participants with PD-L1 expression level < 1%. and all randomized participants)<br>_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 Outcome Measures
Name Time Method Secondary end point(s): _Overall Survival (OS);<br>_PD-L1 expression;<br>_ Objective response rates (if applicable)<br>_ Duration of treatment on next-line therapies<br>_PFS2 defined as time from randomization to second recurrence/objective disease progression, or death<br>from any cause, whichever occurs first.<br>_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;<br>_Approximately 3 years for PD-L1 expression.