A Phase 1 interventional study of Lirilumab and Ipilimumab in CANCER, NOS, sponsored by Bristol-Myers Squibb. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-22.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Inclusion Criteria:
Exclusion Criteria:
Lirilumab and Ipilimumab on specific days
Drug: Lirilumab · Drug: Ipilimumab
Also known as: BMS-986015, IPH-2102, ANTI-KIR
Also known as: BMS-734016
Safety as measured by the rate of adverse events, and serious adverse events
Time frame: Approximately 510 days
Efficacy as measured by tumor assessment
Time frame: Assessed from the start of treatment (ay 1) to the end of treatment (week 60) and for 90 days in follow-up
The maximum observed serum concentration (Cmax) of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2. (EOI is end of infusion, EOT is end of treatment
The time of maximum observed serum concentration (Tmax) of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, EOT, follow-up 1 and follow-up 2
Apparent total body clearance (CL) of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2
Apparent volume of distribution at steady state (Vss) of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2
Serum half-life (T-HALF) of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2
Trough observed serum concentration (Cmin) of BMS-986015 and Ipilimumab
Time frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2
Immunogenicity as measured by the incidence of Ipilimumab and anti-Killer cell immunoglobulin-like receptor (KIR) (BMS-986015) anti-drug antibodies (ADA)
Time frame: up to 11 timepoints during Weeks 1, 3, 4, 10, 13, 24, 36,48, 60, follow-up 1 and follow-up 2
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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