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Therapy Name | Epacadostat + Pembrolizumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Epacadostat | INCB024360|INCB 024360|INCB-024360 | IDO1 Inhibitor 12 | 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 149 PD-L1/PD-1 antibody 121 | 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, 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, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov). |
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 |
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NCT03291054 | Phase II | Epacadostat + Pembrolizumab | Epacadostat and Pembrolizumab in Patients With GIST | Terminated | USA | 0 |
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 |
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 |
NCT03196232 | Phase II | Epacadostat + Pembrolizumab | Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer | Completed | USA | 0 |
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) | Active, not recruiting | USA | TUR | POL | ITA | HUN | GBR | ESP | CAN | AUT | AUS | 4 |
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 |
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 |
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 | Active, not recruiting | USA | TUR | NZL | NOR | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 6 |
NCT03602586 | Phase II | Epacadostat + Pembrolizumab | Pembrolizumab and Epacadostat in Treating Participants With Recurrent, Persistent, or Progressive Ovarian Clear Cell Carcinoma | Completed | USA | 1 |
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 |
NCT03463161 | Phase II | Epacadostat + Pembrolizumab | Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy (ORKA) | Terminated | 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 | |
NCT03402880 | Phase II | Epacadostat + Pembrolizumab | ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer | Withdrawn | 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 |
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 |
NCT02364076 | Phase II | Epacadostat + Pembrolizumab | Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma | Unknown status | USA | 0 |
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 |
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 |