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BMS-982470

Phase 1

Melanoma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Trials Updated: Mar 6, 2015

BMS-982470 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2012

BMS-982470 target and mechanism

ModalityMonoclonal antibody

Also known as BMS-982470 (recombinant interleukin-21), Denenicokin, rIL-21(recombinant interleukin 21)

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials2
Total Enrollment75

FDA Designations

No designations recorded

BMS-982470 clinical trials

BMS-982470 · 2 trials · 2 indications

Phase 1 2
NCT01629758Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid TumorsNeoplasms by Site
COMPLETED33 Analytics
NCT01489059Safety Study of IL-21/Ipilimumab Combination in the Treatment of MelanomaMelanoma
COMPLETED42 Analytics
PHASE1COMPLETED
Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
Neoplasms by SiteUnlock trial analytics
PHASE1COMPLETED
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety, as measured by the rate of adverse events and serious adverse events
Approximately up to 4.5 years
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 as measured by tumor assessment (RECIST)
Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year)
Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558
Up to 2 years + 100 days post-treatment follow-up
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558EXPERIMENTALDose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558EXPERIMENTALDose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558EXPERIMENTALCohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
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
DenenicokinBIOLOGICAL -
NivolumabBIOLOGICAL -
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 Sites5

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * All subjects will have locally advanced or metastatic solid tumors * For Part 2 (Cohort Expansion): * Tumor types will be restricted to clear cell renal cell carcinoma (cc...

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

What is BMS-982470?

BMS-982470 is an investigational recombinant interleukin-21 therapy being developed by Bristol-Myers Squibb for the treatment of melanoma. It is a monoclonal antibody studied in a Phase 1 clinical trial in combination with ipilimumab. It is not approved and remains in clinical development.

What is BMS-982470 used for in melanoma?

BMS-982470 was studied for the treatment of melanoma, specifically in combination with ipilimumab in a Phase 1 safety trial. The study enrolled 42 participants with melanoma across the United States and Puerto Rico. BMS-982470 is investigational and has not been approved for any indication.

Who makes BMS-982470?

BMS-982470 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 melanoma trial evaluating BMS-982470 in combination with ipilimumab.

What phase is BMS-982470 in?

BMS-982470 is in Phase 1 clinical development. Its single trial, NCT01489059, has been completed, and no active trials are ongoing. BMS-982470 is investigational and has not received FDA approval for melanoma or any other indication.

What clinical trials is BMS-982470 in?

BMS-982470 was evaluated in one clinical trial, NCT01489059, titled Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma. The Phase 1 trial enrolled 42 participants aged 18 and older in the United States and Puerto Rico and is now completed.

Is BMS-982470 the same as recombinant interleukin-21?

Yes, BMS-982470 is also known as recombinant interleukin-21. Both names refer to the same investigational Bristol-Myers Squibb agent studied in melanoma. Searches for either name point to the same Phase 1 program and the same completed trial, NCT01489059.