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Denenicokin

Phase 1

Neoplasms by Site | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 6, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

Denenicokin · 1 trial · 1 indication

Phase 1 1
NCT01629758Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid TumorsNeoplasms by Site
COMPLETED33 Analytics
PHASE1COMPLETED
Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
Neoplasms by SiteUnlock 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

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
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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

Interventions

NameTypeDescription
DenenicokinBIOLOGICAL -
NivolumabBIOLOGICAL -
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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 States
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Frequently asked questions about Denenicokin

What is Denenicokin used for?

Denenicokin is an investigational monoclonal antibody being studied for the treatment of neoplasms by site, a category of solid tumors. It is in Phase 1 clinical development for oncology indications. The drug is not yet approved and remains under investigation.

What does Denenicokin target?

Denenicokin is a monoclonal antibody that targets the IL-21 receptor pathway. It is designed to modulate immune responses in the context of cancer therapy. The specific molecular target is IL-21, a cytokine involved in immune cell regulation.

Who makes Denenicokin?

Denenicokin is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is Denenicokin in?

Denenicokin is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being evaluated for safety and tolerability in patients with solid tumors.

What clinical trials is Denenicokin in?

Denenicokin has been studied in one completed Phase 1 clinical trial, NCT01629758, titled "Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors." The trial enrolled 33 participants in the United States and evaluated the drug in patients with neoplasms by site.

Is Denenicokin the same as IL-21?

Denenicokin is a monoclonal antibody that targets IL-21, but it is not the same as IL-21 itself. IL-21 is a cytokine, while Denenicokin is an antibody designed to interact with the IL-21 pathway. The drug is being studied for its potential role in cancer treatment.