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BMS-982470

Phase 1

Melanoma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 29, 2014

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

BMS-982470 · 1 trial · 1 indication

Phase 1 1
NCT01489059Safety Study of IL-21/Ipilimumab Combination in the Treatment of MelanomaMelanoma
COMPLETED42 Analytics
PHASE1COMPLETED
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab
Within the first 63 days

Based on the dose-limiting toxicity (DLT) rate

Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules
84 days on treatment

Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests

Secondary Endpoints

Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response
Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up
Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - Arm 1: BMS-982470 (Daily x 5) + IpilimumabEXPERIMENTALDose Escalation
Part 1 - Arm 2: BMS-982470 (Weekly) + IpilimumabEXPERIMENTALDose Escalation
Part 2 - Arm 1: BMS-982470 (Daily x 5) + IpilimumabEXPERIMENTALCohort Expansion
Part 2 - Arm 2: BMS-982470 (Weekly) + IpilimumabEXPERIMENTALCohort Expansion
Part 2 - Arm 3: Ipilimumab monotherapyACTIVE_COMPARATORCohort Expansion

Interventions

NameTypeDescription
BMS-982470 (recombinant interleukin-21)BIOLOGICALSolution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
IpilimumabBIOLOGICALSolution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Unresectable Stage III or Stage IV melanoma * Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Progra...

Countries:United StatesPuerto Rico
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Frequently asked questions about BMS-982470

What is BMS-982470 used for?

BMS-982470 is an investigational monoclonal antibody being developed for the treatment of melanoma, a type of skin cancer. It is currently in Phase 1 clinical development, meaning it is being studied for safety and dosing in humans. As an investigational drug, it has not yet been approved by regulatory authorities.

Who makes BMS-982470?

BMS-982470 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company. Bristol-Myers Squibb is publicly traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for melanoma.

What phase is BMS-982470 in?

BMS-982470 is in Phase 1 clinical development. This early-stage trial is designed to evaluate the safety, tolerability, and pharmacokinetics of the drug in patients with melanoma. The Phase 1 study has been completed, and the drug remains investigational, meaning it is not yet approved for commercial use.

What clinical trials is BMS-982470 in?

BMS-982470 has been studied in one clinical trial, identified as NCT01489059. This Phase 1 study, titled "Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma," enrolled 42 participants with melanoma. The trial was conducted in the United States and Puerto Rico and has been completed.

How does BMS-982470 work?

BMS-982470 is a monoclonal antibody, a type of targeted therapy designed to bind to specific proteins involved in disease. In the context of melanoma, it is being studied in combination with ipilimumab, another monoclonal antibody. The exact molecular target of BMS-982470 has not been disclosed in available information.