Therapy Detail

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Therapy Name Epacadostat + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Epacadostat INCB024360 IDO1 Inhibitor 10 Immune Checkpoint Inhibitor 94 Epacadostat (INCB024360) inhibits indoleamine 2,3-dioxygenase 1 (IDO1) to prevent tryptophan breakdown in the tumor microenvironment, thereby activating a cytotoxic immune response against IDO1 expressing tumor cells (PMID: 20197554).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, PD-L1 expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, and cervical cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib in RCC, and with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown clear cell renal cell carcinoma not applicable Epacadostat + Pembrolizumab Phase Ib/II Actionable In a Phase I/II trial, Epacadostat (INCB024360) and Keytruda (pembrolizumab) combination treatment resulted in complete response in 5% (1/19), partial response in 42% (8/19), and stable disease in 10% (2/19) of patients with advanced clear cell renal cell carcinoma (J Clin Oncol 35, 2017 (suppl; abstr 4515)). detail...
Unknown unknown Advanced Solid Tumor not applicable Epacadostat + Pembrolizumab Phase I Actionable In a Phase I trial (ECHO-202/KEYNOTE-037), combined treatment with Epacadostat (INCB024360) and Keytruda (pembrolizumab) was well tolerated and resulted in objective responses (OR) in 40% (25/62, 8 complete responses, 17 partial responses) of patients with advanced solid tumors, including melanoma (12/22 OR), non-small cell lung cancer (5/12 OR), and renal cell carcinoma (2/11 OR) (PMID: 30265610; NCT02178722). 30265610

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03414229 Phase II Epacadostat + Pembrolizumab A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma Active, not recruiting
NCT02364076 Phase II Epacadostat + Pembrolizumab Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma Active, not recruiting
NCT03602586 Phase II Epacadostat + Pembrolizumab Pembrolizumab and Epacadostat in Treating Participants With Recurrent, Persistent, or Progressive Ovarian Clear Cell Carcinoma Suspended
NCT02178722 Phase Ib/II Epacadostat + Pembrolizumab Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers Active, not recruiting
NCT03310567 Phase II Epacadostat + Pembrolizumab A Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma Withdrawn
NCT03358472 Phase III Pembrolizumab Carboplatin + Fluorouracil Epacadostat + Pembrolizumab Cetuximab + Cisplatin Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304) Active, not recruiting
NCT02393248 Phase Ib/II Cisplatin + Gemcitabine + Pemigatinib Docetaxel + Pemigatinib Pemigatinib + Retifanlimab Pemigatinib + Trastuzumab Epacadostat + Pembrolizumab Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) Recruiting
NCT03374488 Phase III Epacadostat + Pembrolizumab Pembrolizumab Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma Active, not recruiting
NCT03291054 Phase II Epacadostat + Pembrolizumab Epacadostat and Pembrolizumab in Patients With GIST Active, not recruiting
NCT03238638 Phase II Epacadostat + Pembrolizumab A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Withdrawn
NCT03322540 Phase II Pembrolizumab Epacadostat + Pembrolizumab Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05) Active, not recruiting
NCT03322566 Phase II Carboplatin + Paclitaxel + Pembrolizumab Epacadostat + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Pemetrexed Disodium Carboplatin + Epacadostat + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Epacadostat + Paclitaxel + Pembrolizumab Cisplatin + Epacadostat + Pembrolizumab + Pemetrexed Disodium A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06) Active, not recruiting
NCT02752074 Phase III Epacadostat + Pembrolizumab Pembrolizumab A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma Completed
NCT03196232 Phase II Epacadostat + Pembrolizumab Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Completed
NCT03402880 Phase II Epacadostat + Pembrolizumab ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer Withdrawn
NCT03463161 Phase II Epacadostat + Pembrolizumab Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy (ORKA) Terminated
NCT03260894 Phase III Epacadostat + Pembrolizumab Pazopanib + Sunitinib Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC Active, not recruiting
NCT03325465 Phase II Epacadostat + Pembrolizumab Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck Withdrawn
NCT03361865 Phase III Epacadostat + Pembrolizumab Pembrolizumab Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) Active, not recruiting
NCT03432676 Phase II Epacadostat + Pembrolizumab Study of IDO-1 Inhibitor Epacadostat in Combination With Pembrolizumab in Advanced Pancreatic Cancer With Chromosomal Instability/ Homologous Recombination Repair Deficiency (HRD) Withdrawn


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