The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
Yale University School Of Medicine
New Haven, Connecticut, United States
Medstar Georgetown-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Hillman Cancer Research Pavilion
Pittsburgh, Pennsylvania, United States
Number of Participants With an Adverse Event (AE)
incidence of all cause and treatment related adverse events
Time frame: Up to 3 years
Number of Participants With a Serious Adverse Event (AE)
incidence of all cause and treatment related serious adverse events
Time frame: Up to 3 years
Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation
incidence of all cause and treatment related adverse events which lead to discontinuation
Time frame: Up to 3 years
Number of Deaths
incidence of all cause and treatment related deaths
Time frame: Up to 3 years
Number of Participants With Select AEs
incidence of all cause and treatment related Adverse events in certain organ systems
Time frame: Up to 3 years
Laboratory Abnormalities: Specific Liver Tests
Number of Participants with On-Treatment Laboratory Abnormalities in Specific Liver Tests Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Time frame: Up to 3 years
Laboratory Abnormalities: Specific Thyroid Tests
Number of Participants with On-Treatment Laboratory Abnormalities in Specific Thyroid Tests Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Objective Response Rate
the total number of participants whose best overall response (BOR) is either irCR or irPR divided by the total number of response-evaluable participants.
Time frame: Up to 3 years
Time to Response
the time from the first dose of study drug until the first documentation of irCR or irPR, as related to current database lock date or most current tumor measurement
Time frame: Up to 3 Years
Duration of Response
the time from the first documented response (irCR or irPR) until progression or death, whichever occurs first. For participants who did not progress or die, duration of response will be censored on the date of the last tumor assessment.
Time frame: from the first documented response (irCR or irPR) until progression or death
Progression Free Survival
the time from the first dose to the first observation of disease progression or death due to any cause. If a participant has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. Participants who did not have any on-study tumor assessments and did not die will be censored on the date of the first dose of study medication.
Time frame: 156 weeks
Number of Participants With an Anti-Drug Antibody (ADA) Response for Nivolumab (Nivo) and Ipilimumab (Ipi)
Serum samples will be collected to evaluate the development of antibodies to BMS-936558 and to ipilimumab.
Time frame: Up to 3 years
Peak and Trough Concentrations
The peak and trough concentrations of BMS-936558 (MDX-1106) and ipilimumab in participants with quantifiable data
Time frame: Up to 64 Weeks