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|INCB 024360|INCB-024360 IDO1 Inhibitor 13 Epacadostat (INCB024360) inhibits indoleamine 2,3-dioxygenase 1 (IDO1) to prevent conversion of tryptophan to kynurenine, potentially resulting in increased proliferation of T-cells and natural killer cells and enhanced anti-tumor immune response (PMID: 20197554).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 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, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Completed USA | TUR | POL | ITA | ISR | IRL | GBR | EST | ESP | DNK | CHE | CAN | AUS 5
NCT03291054 Phase II Epacadostat + Pembrolizumab Epacadostat and Pembrolizumab in Patients With GIST Terminated USA 0
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) Terminated USA | DNK 0
NCT02752074 Phase III Epacadostat + Pembrolizumab Pembrolizumab A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma Completed USA | SWE | POL | NZL | NLD | ITA | ISR | IRL | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUS 6
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 USA 0
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 0
NCT03602586 Phase II Epacadostat + Pembrolizumab Pembrolizumab and Epacadostat in Treating Participants With Recurrent, Persistent, or Progressive Ovarian Clear Cell Carcinoma Completed USA 1
NCT03310567 Phase II Epacadostat + Pembrolizumab A Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma Withdrawn USA 0
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) Completed USA | TUR | POL | ITA | HUN | GBR | ESP | CAN | AUT | AUS 4
NCT03325465 Phase II Epacadostat + Pembrolizumab Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck Withdrawn USA 0
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) Completed USA | TUR | ITA | ISR | IRL | HUN | GBR | ESP | CAN | AUS 4
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 Completed USA 0
NCT03260894 Phase III Epacadostat + Pembrolizumab Pazopanib + Sunitinib Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC Completed USA | TUR | NZL | NOR | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CAN | BRA | AUS 6
NCT03361865 Phase III Epacadostat + Pembrolizumab Pembrolizumab Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) Completed USA | POL | NLD | ITA | ISR | IRL | GBR | FRA | ESP | DEU | CAN | BEL | AUS 5
NCT03196232 Phase II Epacadostat + Pembrolizumab Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Completed USA 0
NCT02364076 Phase II Epacadostat + Pembrolizumab Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma Unknown status USA 0
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 USA 0
NCT03463161 Phase II Epacadostat + Pembrolizumab Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy (ORKA) Terminated USA 0
NCT03374488 Phase III Epacadostat + Pembrolizumab Pembrolizumab Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma Completed USA | TUR | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CAN | AUS 4
NCT03402880 Phase II Epacadostat + Pembrolizumab ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer Withdrawn USA 0


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