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Anti-CD137

Phase 2

Melanoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

Anti-CD137 development status

Highest phase Phase 2
Registered trials 4 across 2 sponsors since Mar 2006

Anti-CD137 target and mechanism

ModalitySmall molecule

Also known as Anti-CD137 (4-1BB) (BMS-663513), BMS-663513

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

Anti-CD137 clinical trials

Anti-CD137 · 1 trial · 1 indication

Phase 2 1
NCT00612664Phase II, 2nd Line Melanoma - RAND MonotherapyMelanoma
COMPLETED158 Analytics
PHASE2COMPLETED
Phase II, 2nd Line Melanoma - RAND Monotherapy
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
every 6 weeks starting at week 12 after randomization

Secondary Endpoints

Safety profiles
throughout the study
Disease response rate
end of study
Disease control rate
end of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR0.1 mg/kg every 3 weeks
Arm 2ACTIVE_COMPARATOR1 mg/kg every 3 weeks
Arm 3ACTIVE_COMPARATOR1 mg/kg every 6 weeks
Arm 4ACTIVE_COMPARATOR5 mg/kg every 3 weeks

Interventions

NameTypeDescription
Anti-CD137 (4-1BB) (BMS-663513)DRUGIV solution, IV, until PD or toxicity
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvan...

Countries:United StatesCanadaDenmarkFranceGermanyItaly
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Frequently asked questions about Anti-CD137

What is anti-CD137 used for?

Anti-CD137 was studied as a treatment for melanoma, specifically as a second-line monotherapy in a Phase 2 trial. It was developed by Bristol-Myers Squibb Company for patients with melanoma. The program is investigational and has not been approved for any indication.

What does anti-CD137 target?

Anti-CD137 targets CD137, also known as 4-1BB, a costimulatory receptor on immune cells. By binding this target, the agent is designed to stimulate immune responses against tumor cells. This mechanism was explored in melanoma as a potential immunotherapy approach.

Who makes anti-CD137?

Anti-CD137 is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the clinical trial evaluating this agent in melanoma. Bristol-Myers Squibb is the sole developer listed for this asset.

What phase is anti-CD137 in?

Anti-CD137 is in Phase 2 development. It has completed one Phase 2 trial in melanoma, and no active trials are currently listed. The drug remains investigational and has not received FDA approval for any indication.

What clinical trials is anti-CD137 in?

Anti-CD137 has been evaluated in one completed Phase 2 trial, NCT00612664, titled "Phase II, 2nd Line Melanoma - RAND Monotherapy." The trial enrolled 158 patients with melanoma across the United States, Canada, Denmark, France, Germany, and Italy. It was randomized and active-controlled.

Is anti-CD137 the same as anti-CD137 (4-1BB) (BMS-663513)?

Yes, anti-CD137 is also known as anti-CD137 (4-1BB) (BMS-663513). These names refer to the same investigational agent developed by Bristol-Myers Squibb. The alternative names reflect its target, CD137 or 4-1BB, and its internal compound designation, BMS-663513.