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Clinical trials for Epacadostat

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Epacadostat. Displaying page 1 of 1.
    EudraCT Number: 2017-001810-27 Sponsor Protocol Number: MK-3475-715(INCB024360-306) Start Date*: 2017-12-15
    Sponsor Name:Incyte Corporation
    Full Title: A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) with Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Pl...
    Medical condition: First-line treatment of metastatic NSCLC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) ES (Completed) DE (Prematurely Ended) HU (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001841-28 Sponsor Protocol Number: MK-3475-654(INCB24360-305) Start Date*: 2017-11-03
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) plus Epacadostat (INCB024360) Versus Pembrolizumab plus Placebo as First-Line Treatment in Patients with Metastatic Non-Small Ce...
    Medical condition: Metastatic NSCLC with high PD-L1 expression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Completed) EE (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001338-24 Sponsor Protocol Number: MK-3475-669(INCB024360-304) Start Date*: 2017-12-05
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First line Treatment for...
    Medical condition: Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) ES (Temporarily Halted) PT (Trial now transitioned) AT (Prematurely Ended) HU (Completed) PL (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002259-26 Sponsor Protocol Number: MK-3475-679_(INCB024360 Start Date*: 2017-11-28
    Sponsor Name:Incyte Corporation
    Full Title: A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally ...
    Medical condition: Locally advanced or metastatic renal cell cancer (mRCC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10038407 Renal cell cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) IE (Prematurely Ended) ES (Temporarily Halted) NO (Completed) HU (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002311-34 Sponsor Protocol Number: MK-3475-672(INCB24360-ECHO-307) Start Date*: 2017-12-12
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3 Randomized, Double-blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-6...
    Medical condition: Bladder cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Temporarily Halted) NL (Completed) GB (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002423-29 Sponsor Protocol Number: INCB24360-204 Start Date*: 2017-07-13
    Sponsor Name:incyte Corporation
    Full Title: A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers
    Medical condition: Selected advanced cancers, including metastatic and/or unresectable solid tumors including NSCLC, melanoma,adenocarcinoma of the colon or rectum , recurrent squamous cell carcinoma of the head and ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002310-31 Sponsor Protocol Number: INCB24360-303 Start Date*: 2018-04-13
    Sponsor Name:Incyte Corporation
    Full Title: Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who...
    Medical condition: Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) GB (Completed) NL (Completed) ES (Temporarily Halted) HU (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004991-31 Sponsor Protocol Number: INCB24360-301/MK3475-252/Keynote252 Start Date*: 2016-05-03
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (Keynote-252 ...
    Medical condition: Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10053571 Melanoma LLT
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) NL (Completed) DK (Completed) IE (Completed) ES (Completed) PL (Completed) FR (Completed) BE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003305-18 Sponsor Protocol Number: INCB24360-310 Start Date*: 2018-03-23
    Sponsor Name:Incyte Corporation
    Full Title: A Randomized, Global, Phase 3 Trial of Nivolumab Plus Epacadostat in Combination with Chemotherapy (platinum + 5-fluorouracil) versus the EXTREME Regimen (cetuximab + platinum + 5-fluorouracil) in ...
    Medical condition: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001743-12 Sponsor Protocol Number: INCB24360-208 Start Date*: 2018-07-04
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Maligna...
    Medical condition: Phase 1 (Dose Escalation): Advanced or metastatic solid tumors. Phase 2 (Dose Expansion): Advanced or metastatic non–small cell lung cancer (NSCLC), unresectable or metastatic melanoma (MEL) and r...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10050017 Lung cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027480 Metastatic malignant melanoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027150 Melanoma malignant LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027481 Metastatic melanoma LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065143 Malignant solid tumour LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071540 Head and neck cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-003304-43 Sponsor Protocol Number: INCB24360-309 Start Date*: 2018-04-12
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat with Platinum Doublet Chemotherapy versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small C...
    Medical condition: Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004678-16 Sponsor Protocol Number: INCB24360-207 Start Date*: 2018-05-31
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors
    Medical condition: Subjects with solid tumors of the type of colorectal cancer, pancreatic ductal adenocarcinoma, Squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, any solid tumor that pro...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10051971 Pancreatic adenocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10079440 Non-squamous non-small cell lung cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10064467 Urothelial carcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004289-25 Sponsor Protocol Number: INCB24360-206 Start Date*: 2017-07-14
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced S...
    Medical condition: Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non–Small Cell Lung Cancer and Stage IV Microsatellite Stable Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010035 Colorectal cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10048683 Advanced cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-002244-23 Sponsor Protocol Number: INCB24360-901 Start Date*: 2021-07-28
    Sponsor Name:Incyte Corporation
    Full Title: An Open-Label, Randomized, Phase 2, Umbrella Study of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse ...
    Medical condition: Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000496-20 Sponsor Protocol Number: INCMGA0012-204 Start Date*: 2021-01-08
    Sponsor Name:Incyte Corporation
    Full Title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemothe...
    Medical condition: Endometrial cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014733 Endometrial cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014734 Endometrial cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Trial now transitioned) DE (Prematurely Ended) BE (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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