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Pembrolizumab

Phase 2

Metastatic Uveal Melanoma | Small molecule | Oncology |Syndax Pharmaceuticals, Inc.|Last Updated: Dec 8, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

Pembrolizumab · 1 trial · 1 indication

Phase 2 1
NCT02697630Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the EyeMetastatic Uveal Melanoma
COMPLETED29 Analytics
PHASE2COMPLETED
Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye
Metastatic Uveal MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
From first dose up to 24 months

The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.

Secondary Endpoints

Clinical benefit rate (CBR)
18 weeks from first dose
Progression free survival (PFS)
From first dose up to 24 months
Overall Survival (OS)
From first dose up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pembrolizumab and EntinostatEXPERIMENTAL -

Interventions

NameTypeDescription
PembrolizumabDRUG200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months
EntinostatDRUG5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age above 18 years. * Signed and dated written informed consent before the start of specific protocol procedures. * ECOG PS 0-1 * Histologically/cytologically confirmed stage IV uveal melanoma * Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI)...

Countries:Sweden
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Frequently asked questions about Pembrolizumab

What is Pembrolizumab used for in Metastatic Uveal Melanoma?

Pembrolizumab is being studied for the treatment of metastatic uveal melanoma, a type of eye cancer that has spread. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated in combination with entinostat in a completed clinical trial.

What does Pembrolizumab target?

Pembrolizumab targets the PD-1 receptor, a protein on immune cells that helps regulate immune responses. By blocking PD-1, it enhances the body's immune system to attack cancer cells. This mechanism is being studied in the context of metastatic uveal melanoma.

Who makes Pembrolizumab?

Pembrolizumab is being developed by Syndax Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock ticker is SNDX. Syndax is conducting clinical research to evaluate the drug's safety and efficacy in patients with metastatic uveal melanoma.

What phase is Pembrolizumab in?

Pembrolizumab is in Phase 2 clinical development for metastatic uveal melanoma. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial to assess its effects in this patient population.

What clinical trials is Pembrolizumab in?

Pembrolizumab is being studied in clinical trial NCT02697630, titled 'Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye.' This Phase 2 trial enrolled 29 participants in Sweden and has been completed. The study was not randomized or blinded and did not use a control group.