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pembrolizumab+ epacadostat

Phase 3

Melanoma | Small molecule | Oncology |Incyte Corporation|Last Updated: Aug 24, 2025

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalitySmall molecule

Also known as Pembrolizumab

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment706

FDA Designations

No designations recorded

Clinical trial landscape

pembrolizumab+ epacadostat · 1 trial · 1 indication

Phase 3 1
NCT02752074A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)Melanoma
COMPLETED706 Analytics
PHASE3COMPLETED
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months

Progression-free survival, defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.

Overall Survival (OS) Rate at 6 Months
Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.

Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.

Secondary Endpoints

Objective Response Rate (ORR)
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events
Through up to 90 days after end of treatment, up to 27 months
Duration of Response (DOR)
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pembrolizumab + EpacadostatEXPERIMENTALPembrolizumab + Epacadostat
Pembrolizumab + PlaceboACTIVE_COMPARATORPembrolizumab + Placebo

Interventions

NameTypeDescription
pembrolizumab + epacadostatDRUG* Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1) * Epacadostat will be administered orally daily starting at Day 1 (Week 1)
pembrolizumab + placeboDRUG* Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1) * Placebo will be administered orally daily starting at Day 1 (Week 1)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites129

Inclusion Criteria: * Have histologically or cytologically confirmed melanoma * Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy * A minimum of 1 measurable lesion by CT or MRI * Provide a baseline tumor biopsy * Eastern Cooperative Oncology...

Countries:United StatesAustraliaBelgiumCanadaChileDenmarkFranceGermanyIrelandIsraelItalyJapanMexicoNetherlandsNew ZealandPolandRussiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandUnited Kingdom
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Frequently asked questions about pembrolizumab+ epacadostat

What is MK-3475 used for?

MK-3475, also known as pembrolizumab, is an investigational antibody being studied in oncology. It is being evaluated in clinical trials for head and neck cancer, melanoma, colorectal cancer, lung cancer, urothelial cancer, and triple-negative breast cancer. It is currently in Phase 1 development.

What does MK-3475 target?

MK-3475 is a monoclonal antibody, a type of -mab antibody. It is being studied in combination with other agents in clinical trials for various cancers, including melanoma and renal cell carcinoma. Its specific molecular target is not disclosed in the available information.

Who is developing MK-3475?

MK-3475 is being developed by Incyte Corporation, which is listed on the stock exchange under the ticker INCY. The drug is currently in Phase 1 clinical development for multiple oncology indications.

What phase is MK-3475 in?

MK-3475 is in Phase 1 of clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied in clinical trials for several cancer types, including melanoma and triple-negative breast cancer.

What clinical trials is MK-3475 in?

MK-3475 is being studied in several clinical trials. These include a Phase 3 trial in melanoma (NCT02752074), a Phase 3 trial in renal cell carcinoma (NCT03260894), and Phase 2 trials in triple-negative breast cancer (NCT05491226 and NCT07015853). The trials are conducted in multiple countries.

Is MK-3475 the same as pembrolizumab?

Yes, MK-3475 is also known as pembrolizumab. The drug is being studied under both names in clinical trials. It is an investigational antibody being developed by Incyte Corporation for various cancer indications.