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Anti-CD137

Phase 2

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

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

Clinical trial landscape

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 is an investigational oncology therapy being studied for the treatment of melanoma. It is currently in Phase 2 clinical development as a monotherapy for second-line melanoma. The drug is being developed by Bristol-Myers Squibb Company (BMY).

What does Anti-CD137 target?

Anti-CD137 targets the CD137 receptor, which is a costimulatory molecule involved in the activation of immune cells such as T cells. By targeting CD137, the drug aims to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated in the context of melanoma treatment.

Who makes Anti-CD137?

Anti-CD137 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with melanoma.

What phase is Anti-CD137 in?

Anti-CD137 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing clinical program includes a completed Phase 2 trial that enrolled 158 participants with melanoma.

What clinical trials is Anti-CD137 in?

Anti-CD137 is being studied in a Phase 2 clinical trial with the identifier NCT00612664. This trial, titled 'Phase II, 2nd Line Melanoma - RAND Monotherapy,' was a randomized, active-controlled study that has been completed. It enrolled 158 participants across multiple countries, including the United States, Canada, Denmark, France, Germany, and Italy.