Drugs / Epacadostat
Trials 58
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02042430 | Aug 2014 → Nov 2016 | fallopian tube cancer, primary peritoneal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT03471286 | Jun 2019 → Jul 2021 | cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT03707457 | Mar → Nov 2019 | glioblastoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03491579 | Dec 2018 → Sep 2019 | acute myeloid leukemia | Insel Gruppe AG, University Hospital Bern | Withdrawn | No outcome recorded |
| Phase 1 | NCT03444649 | Sep 2018 → Aug 2019 | acute myeloid leukemia | Insel Gruppe AG, University Hospital Bern | Withdrawn | No outcome recorded |
| Phase 1 | NCT03589651 | Aug 2018 → Nov 2022 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03217669 | Feb 2018 → Apr 2024 | non-small cell lung carcinoma | Chao Huang | Unknown | No outcome recorded |
| Phase 1 | NCT02862457 | Aug 2016 → Nov 2020 | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02559492 | Nov 2015 → Sep 2018 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT02298153 | Jan 2015 → Nov 2017 | non-small cell lung carcinoma, urothelial carcinoma | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT02118285 | Jul 2014 → Nov 2015 | fallopian tube carcinoma, ovarian cancer, primary peritoneal carcinoma | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 1 | NCT01195311 | Jul 2010 → May 2013 | hematopoietic and lymphoid cell neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/216 trials · 1 missed | ||||||
| Phase 1/2 | NCT03516708 | Jan 2020 → Jul 2027 expected | rectal cancer | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03182894 | Sep 2018 → Jul 2019 | colorectal cancer | James J Lee | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03493945 | May 2018 → Oct 2024 | castration-resistant prostate carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT03347123 | Mar 2018 → Jan 2021 | cancer | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03361228 | Mar 2018 → Mar 2019 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT03322384 | Jan 2018 → Feb 2020 | cancer, lymphoma | University of California, Davis | Completed | No outcome recorded |
| Phase 1/2 | NCT03085914 | May 2017 → Jan 2019 | cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02959437 | Feb 2017 → Feb 2019 | metastatic malignant neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT02785250 | Apr 2016 → Oct 2020 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | ImmunoVaccine Technologies, Inc. (IMV Inc.) | Unknown | No outcome recorded |
| Phase 1/2 | NCT02575807 | Mar 2016 → Apr 2018 | fallopian tube cancer, peritoneum cancer | Aduro Biotech, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02318277 | Jan 2015 → Aug 2019 | head and neck cancer, lung cancer, urothelial carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02327078 | Nov 2014 → Jun 2020 | B-cell neoplasm, colorectal cancer, glioblastoma, head and neck cancer +3 | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT02166905 | Oct 2014 → Aug 2020 | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | Roswell Park Cancer Institute | Completed | Missed primary |
| Phase 1/2 | NCT02178722 | Jul 2014 → Nov 2018 | colorectal cancer, endometrial cancer, gastric cancer, head and neck cancer +9 | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT01982487 | Dec 2013 → Sep 2017 | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01604889 | Mar 2012 → Dec 2016 | melanoma | Incyte Corporation | Terminated | No outcome recorded |
| Phase 223 trials · 3 missed | ||||||
| Phase 2 | NCT04586244 | Jan 2022 → Jan 2024 | urothelial carcinoma | Incyte Corporation | Terminated | Missed primary Stop: Business |
| Phase 2 | NCT04463771 | Jan 2021 → May 2026 | endometrial cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04231864 | Dec 2020 → Apr 2022 | nasopharyngeal carcinoma | Alain Algazi | Withdrawn | No outcome recorded |
| Phase 2 | NCT03532295 | Apr 2020 → Jul 2024 | glioblastoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT03432676 | Jul 2019 → Apr 2020 | ATM-related cancer predisposition, BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, pancreatic ductal adenocarcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03832673 | May 2019 | urinary bladder carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Withdrawn | No outcome recorded |
| Phase 2 | NCT03823131 | May 2019 → Jul 2022 | head and neck squamous cell carcinoma | Chase Heaton, MD | Terminated | No outcome recorded |
| Phase 2 | NCT03602586 | Dec 2018 → Feb 2021 | ovarian carcinoma, ovarian clear cell cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03402880 | Oct 2018 | small cell lung carcinoma | City of Hope Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03238638 | Sep 2018 → Dec 2020 | head and neck cancer | University of Chicago | Withdrawn | No outcome recorded |
| Phase 2 | NCT03310567 | Sep 2018 | endometrial carcinoma | Fox Chase Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03592407 | Jul 2018 → Apr 2020 | esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03463161 | Mar → Dec 2018 | head and neck squamous cell carcinoma | University of Chicago | Terminated | No outcome recorded |
| Phase 2 | NCT03291054 | Feb 2018 → Aug 2020 | gastrointestinal stromal tumor | Columbia University | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03006302 | Jan 2018 → Aug 2023 | pancreatic adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT03414229 | Jan 2018 → Sep 2024 overdue | sarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03325465 | Jan → Nov 2018 | head and neck squamous cell carcinoma | University of Chicago | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03322566 | Jan → Dec 2018 | lung cancer | Incyte Corporation | Completed | Missed primary |
| Phase 2 | NCT03322540 | Dec 2017 → Jan 2019 | lung cancer | Incyte Corporation | Completed | Missed primary |
| Phase 2 | NCT03196232 | Sep 2017 → May 2018 | carcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | George Albert Fisher | Completed | No outcome recorded |
| Phase 2 | NCT02364076 | Mar 2015 → Jun 2019 | thymic carcinoma | Georgetown University | Unknown | No outcome recorded |
| Phase 2 | NCT01961115 | Sep 2013 → Oct 2016 | cutaneous melanoma, mucosal melanoma, uveal melanoma | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01822691 | Jul 2013 → Jan 2015 | myelodysplastic syndrome | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 37 trials · 1 missed | ||||||
| Phase 3 | NCT03348904 | Dec 2017 → May 2018 | lung cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT03374488 | Dec 2017 → Jul 2018 | urothelial carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03342352 | Dec 2017 → Apr 2018 | head and neck cancer | Incyte Corporation | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03260894 | Dec 2017 → Aug 2018 | renal cell carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03361865 | Dec 2017 → Aug 2018 | urothelial carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03358472 | Dec 2017 → Jul 2018 | head and neck squamous cell carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02752074 | Jun 2016 → Jan 2018 | melanoma | Incyte Corporation | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT03277352 Background | Nov 2017 → Jul 2020 | metastatic malignant neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT01685255 Comparator | Aug 2012 → Oct 2014 | ovarian carcinoma | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2018-04-06 | Merck Sharp & Dohme LLC | Results Incyte and Merck Provide Update on Phase 3 Study of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) in Patients with Unresectable or Metastatic Melanoma merck.com ↗
Based on these results, and at the recommendation of the eDMC, the study will be stopped. |
| 2018-04-06 | Incyte Corporation | Results Incyte and Merck Provide Update on Phase 3 Study of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) in Patients with Unresectable or Metastatic Melanoma incyte.com ↗
Based on these results, and at the recommendation of the eDMC, the study will be stopped. |
| 2017-09-09 | Merck Sharp & Dohme LLC | Results Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma merck.com ↗
Results were generally consistent across dosing schedules of epacadostat combined with KEYTRUDA, including epacadostat 100 mg BID, the epacadostat dose being studied in the Phase 3 ECHO-301 trial. |
| 2017-09-09 | Incyte Corporation | Results Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma incyte.com ↗
Among all patients with advanced melanoma, including treatment-naïve and treatment-experienced, data showed an overall response rate (ORR) of 56 percent (n=35/63) in patients treated with the combination of epacadostat and KEYTRUDA; median progression-free survival (PFS) was 12.4 months, with PFS rates of 65 percent at six months, 52 percent at 12 months, and 49 percent at 18 months. |
| 2017-09-09 | Incyte Corporation | Results Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma incyte.com ↗
Results were generally consistent across dosing schedules of epacadostat combined with KEYTRUDA, including epacadostat 100 mg BID, the epacadostat dose being studied in the Phase 3 ECHO-301 trial. |
| 2017-08-30 | Incyte Corporation | Results New Data for Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Demonstrate Durable Responses in Patients with Advanced Melanoma incyte.com ↗ |
| 2017-06-05 | Merck Sharp & Dohme LLC | Results Updated Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Demonstrate Clinical Activity Across Multiple Tumor Types merck.com ↗ |
| 2017-06-05 | Bristol-Myers Squibb | Results Clinical Trial Data for Combination of Epacadostat and Opdivo® (nivolumab) Demonstrate Durable Clinical Responses in Patients with Melanoma and Head and Neck Cancer bms.com ↗
Responses for MEL and SCCHN were observed regardless of PD-L1 expression and HPV status (in SCCHN), and all responses were ongoing at the data cutoff (February 13, 2017). |
| 2017-06-05 | Incyte Corporation | Results Updated Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (Pembrolizumab) Demonstrate Clinical Activity across Multiple Tumor Types incyte.com ↗ |
| 2017-06-05 | Incyte Corporation | Results Clinical Trial Data for Combination of Epacadostat and Opdivo® (nivolumab) Demonstrate Durable Clinical Responses in Patients with Melanoma and Head and Neck Cancer incyte.com ↗
In previously-treated patients with SCCHN who were treated with epacadostat (100 mg or 300 mg) plus nivolumab (n=31), the combined ORR was 23 percent (7/31), including 1 CR and 6 PRs, and the combined DCR was 61 percent (19/31). |
| 2017-06-03 | Merck Sharp & Dohme LLC | Results Combination of Incyte’s Epacadostat plus Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) merck.com ↗
Data showed an overall response rate (ORR) of 35 percent (n=14/40) among all patients with advanced squamous and non-squamous NSCLC treated with the combination of epacadostat and KEYTRUDA, irrespective of PD-L1 status. |
| 2017-06-03 | Incyte Corporation | Results Combination of Incyte’s Epacadostat plus Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) incyte.com ↗
Data showed an overall response rate (ORR) of 35 percent (n=14/40) among all patients with advanced squamous and non-squamous NSCLC treated with the combination of epacadostat and KEYTRUDA, irrespective of PD-L1 status. |
| 2017-06-03 | Incyte Corporation | Results Combination of Epacadostat plus Keytruda® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) incyte.com ↗
Data showed an overall response rate (ORR) of 35 percent (n=14/40) among all patients with advanced squamous and non-squamous NSCLC treated with the combination of epacadostat and pembrolizumab, irrespective of PD-L1 status. |
| 2017-05-17 | Incyte Corporation | Results New Data for Presentation at ASCO 2017 Reinforce Clinical Profile of Epacadostat in Combination with Keytruda® (pembrolizumab) incyte.com ↗
Incyte Corporation (Nasdaq:INCY) today announced the publication of new data from the ongoing ECHO-202 trial, evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. |
| 2017-05-17 | Incyte Corporation | Results First Data from Combination of Epacadostat with Opdivo® (nivolumab) Will Be Highlighted at ASCO 2017 incyte.com ↗
These results show that the combination was well-tolerated across patients studied and demonstrates promising clinical responses, particularly in melanoma and SCCHN. |
| 2017-03-02 | Incyte Corporation | Results Incyte’s Targeted Therapy and Immuno-oncology Portfolio to be Featured in 20 Abstracts at the AACR Annual Meeting 2017 incyte.com ↗
Agonist Antibodies Targeting OX40 and GITR Enhance the Activity of the IDO1-Selective Inhibitor Epacadostat in Preclinical Models |
| 2016-10-07 | Incyte Corporation | Results Additional Phase 1 Data from ECHO-202 Reinforce Durability of Response in Patients with Treatment-naive Advanced or Metastatic Melanoma Treated with Epacadostat in Combination with Keytruda® (pembrolizumab) incyte.com ↗
The updated data also show an increase in the complete response (CR) rate to 26 percent. |
| 2016-09-28 | Incyte Corporation | Results Updated Phase 1 Data Reinforce the Clinical Profile of Epacadostat in Combination with Keytruda® (Pembrolizumab) incyte.com ↗
In patients with treatment-naïve advanced melanoma (n=19), updated data show a disease control rate (DCR) of 74 percent and an overall response rate (ORR) of 58 percent. |
| 2015-11-21 | Merck Sharp & Dohme LLC | Results Merck Announces Initial Results for KEYTRUDA® (pembrolizumab) with Novel Immunotherapy Combinations from Three Investigational Studies Presented at the Society for Melanoma Research International Congress merck.com ↗
The findings, which were featured in separate oral presentations today at the Society for Melanoma Research 2015 International Congress (SMR) in San Francisco, showed robust anti-tumor activity with KEYTRUDA in all three combinations studied. |
| 2015-11-03 | Incyte Corporation | Results Epacadostat in Combination with Pembrolizumab Demonstrates Promising Clinical Activity in Multiple Advanced Cancers incyte.com ↗
Results evaluating 19 patients for efficacy and 28 patients for safety, indicate a 79 percent (n=15/19) disease control rate (DCR) in evaluable patients with advanced cancers. |
| 2014-06-02 | Incyte Corporation | Results Incyte Announces Preliminary Results of a Phase I/II Study of Combination Immunotherapy in Patients with Melanoma incyte.com ↗
The poster reported initial findings showing that the combination was generally well tolerated and produced evidence of clinical response. |
| 2013-06-01 | Incyte Corporation | Results Incyte Presents Final Results from a Phase I Trial of INCB024360, a Novel Oral Immunotherapy, at ASCO incyte.com ↗
Data demonstrate that INCB024360 achieves greater than 90 percent inhibition of IDO1 at generally well-tolerated doses and may represent a new treatment option for advanced malignancies |
| 2012-06-04 | Incyte Corporation | Results Incyte Presents Results from a Phase I Trial of INCB024360, a Novel Oral Inhibitor of Indoleamine Dioxygenase-1 (IDO1), at ASCO incyte.com ↗
Incyte Corporation (Nasdaq: INCY) presented preliminary results today from the ongoing Phase I clinical trial for its oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB024360, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. |
All press releases naming this drug 33 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 63 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Epacadostat | “The open-label, phase 1/2 ECHO-203 study evaluated the safety, tolerability, and efficacy of the IDO1 inhibitor epacadostat in combination with durvalumab, a human anti-PD-L1...” PMID 36309837 ↗ Oct 202253“Patients will receive epacadostat in combination with pembrolizumab.” NCT03325465 ↗ |
| Known as | INCB024360 | “Epacadostat (INCB024360) is an inhibitor of the enzyme indoleamine 2,3-dioxygenase 1 (IDO1) that has shown promise in the treatment of solid tumors and lymphomas in ongoing...” NCT03322384 ↗13“INCB024360 (Epacadostat) is an IDO1 inhibitor under investigation in combination with different immunotherapies in treatment of various malignancies.” NCT03493945 ↗ “A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)” NCT02318277 ↗ “Phase II Study of Epacadostat (INCB024360) in Combination With Pembrolizumab in Patients With Locally Advanced/Metastatic Sarcoma” NCT03414229 ↗ “Oral Epacadostat (INCB024360) (50, 100, or 300 mg twice per day,on days 1-21 of each cycle, every 21 days)” NCT03182894 ↗ “Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1).” NCT03444649 ↗ “Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1).” NCT03491579 ↗ “Drug: Epacadostat (INCB024360)” NCT02785250 ↗ |
| Known as | previously INCB24360 | “previously INCB24360” NCT03832673 ↗ |
| Action | Inhibit | “Epacadostat is a potent inhibitor of the immunosuppressive indoleamine 2,3-dioxygenase 1 (IDO1) enzyme.” PMID 30894212 ↗ Mar 2019 |
| Modality | Small molecule | — CHEMBL3545369 ↗ |
| Route | Oral | “Patients received oral epacadostat (25, 50, 100, or 300 mg twice daily [BID]; 75 mg daily [50 mg AM, 25 mg PM]; or 50 mg BID intermittent [2 weeks on/1 week off])” PMID 30894212 ↗ Mar 2019 |
| Target | IDO1 | “Epacadostat is a potent inhibitor of the immunosuppressive indoleamine 2,3-dioxygenase 1 (IDO1) enzyme.” PMID 30894212 ↗ Mar 2019 |