EPIZYME, INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2025-09-02: Study NCT06068881; Company role Lead sponsor; Phase Phase 2; Status Withdrawn.
- 2024-09-05: Study NCT05983965; Company role Collaborator; Phase Phase 1; Status Terminated.
- 2023-12: Study NCT05567679; Company role Collaborator; Phase Early Phase 1; Status Withdrawn.
- 2023-11-01: Study NCT05994235; Company role Collaborator; Phase Phase 2; Status Active not recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2025-09-02 | NCT06068881 A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation | Lead sponsor | Phase 2 | Withdrawn | Follicular Lymphoma; Refractory Follicular Lymphoma | 0 | 2029-04-06 |
| 2024-09-05 | NCT05983965 Study of Tazemetostat in Lymphoid Malignancies | Collaborator Lead: University of Alabama at Birmingham | Phase 1 | Terminated | T-cell Lymphoma | 6 | 2026-03-06 |
| 2023-12 | NCT05567679 A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer | Collaborator Lead: Edwin Posadas, MD | Early Phase 1 | Withdrawn | Prostate Cancer | 0 | 2025-12 |
| 2023-11-01 | NCT05994235 Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma | Collaborator Lead: Weill Medical College of Cornell University | Phase 2 | Active not recruiting | Follicular Lymphoma | 23 | 2033-10 |
| 2023-10-04 | NCT05934838 A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas | Collaborator Lead: Weill Medical College of Cornell University | Phase 1 | Active not recruiting | Follicular Lymphoma; B-Cell Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma | 15 | 2031-09 |
| 2023-08-10 | NCT05407441 Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors | Collaborator Lead: Susan Chi, MD | Phase 1, Phase 2 | Active not recruiting | Atypical Teratoid Rhabdoid Tumor; INI1 (SMARCB1)-Deficient Primary CNS Malignant Tumors; SMARCA4-deficient Primary CNS Malignant Tumors; Malignant Rhabdoid Tumor (MRT); Rhabdoid Tumor of the Kidney (RTK); Epithelioid Sarcoma; Chordoma | 49 | 2029-02-01 |
| 2023-06-07 | NCT05618366 Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma | Collaborator Lead: Weill Medical College of Cornell University | Phase 1 | Terminated | Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma; Follicular Lymphoma | 3 | 2026-02-27 |
| 2023-01-26 | NCT05551936 A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma | Collaborator Lead: Vaishalee Kenkre | Phase 1, Phase 2 | Active not recruiting | Follicular Lymphoma | 42 | 2027-05 |
| 2022-05-31 | NCT05121103 A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma | Lead sponsor | Phase 1 | Terminated Results posted | Multiple Myeloma, Refractory; Diffuse Large B-Cell Lymphoma; Diffuse Large B Cell Lymphoma Refractory; Multiple Myeloma in Relapse | 13 | 2024-04-30 |
| 2021-12-22 | NCT05205252 A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. | Lead sponsor | Phase 1, Phase 2 | Withdrawn | Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy | 0 | 2023-07-05 |
| 2021-08-25 | NCT04917042 Tazemetostat in Malignant Peripheral Nerve Sheath Tumors | Collaborator Lead: University of Florida | Phase 2 | Active not recruiting Results posted | Peripheral Nerve Sheath Tumor | 10 | 2026-12 |
| 2021-07-23 | NCT04705818 Combining Epigenetic And Immune Therapy to Beat Cancer. | Collaborator Lead: Institut Bergonié | Phase 2 | Completed | Advanced Solid Tumor; Advanced Colorectal Carcinoma; Advanced Soft-tissue Sarcoma; Advanced Pancreatic Adenocarcinoma; Adult Solid Tumor | 164 | 2025-07-17 |
| 2021-06-28 | NCT04846478 Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC | Collaborator Lead: Dana-Farber Cancer Institute | Phase 1 | Active not recruiting | Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer | 35 | 2026-12-30 |
| 2021-04-14 | NCT04624113 Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma | Collaborator Lead: Washington University School of Medicine | Phase 1 | Terminated | Head and Neck Squamous Cell Carcinoma | 13 | 2024-02-17 |
| 2020-12-15 | NCT04762160 SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma | Lead sponsor | Phase 2 | Terminated Results posted | Follicular Lymphoma | 5 | 2022-03-22 |
| 2020-06-11 | NCT04224493 A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma. | Lead sponsor | Phase 3 | Active not recruiting | Relapsed/Refractory Follicular Lymphoma; Follicular Lymphoma; Refractory Follicular Lymphoma | 599 | 2029-03-01 |
| 2020-04-23 | NCT04537715 Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels | Lead sponsor | Phase 1 | Completed Results posted | All Malignancies; Advanced Malignancies; Hematologic Malignancy; Solid Tumor; Follicular Lymphoma (FL); Non-Hodgkin Lymphoma (NHL); Diffuse Large B-Cell Lymphoma (DLBCL); Epithelioid Sarcoma (ES); Synovial Sarcoma; Renal Medullary Carcinoma; Mesothelioma; Rhabdoid Tumor | 42 | 2023-04-03 |
| 2020-01-15 | NCT04241835 A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function | Lead sponsor | Phase 1 | Terminated | Hepatic Impairment; Advanced Malignant Solid Tumor | 18 | 2025-03-12 |
| 2019-12-19 | NCT04204941 Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma | Lead sponsor | Phase 1 | Terminated | Advanced Soft-tissue Sarcoma; Advanced Epithelioid Sarcoma | 25 | 2024-06-14 |
| 2019-11-18 | NCT04179864 A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer | Lead sponsor | Phase 1, Phase 2 | Terminated Results posted | Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer | 102 | 2024-11-04 |
| 2018-06-20 | NCT03010982 Open-Label, Multi-Center, Two-Part, Ph1 Study to Characterize the PKs of an Intravenous Micro-Dose of [14C]-Tazemetostat (EPZ 6438) and the ADME of an Oral [14C]-Labeled Dose of Tazemetostat in Subjects With B-Cell Lymphomas or Adv Solid Tumors | Lead sponsor | Phase 1 | Completed | Diffuse Large B Cell Lymphoma; Primary Mediastinal Lymphoma; Mantle-Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Advanced Solid Tumors | 3 | 2019-01-08 |
| 2018-06-04 | NCT03837678 Epithelioid Sarcoma Natural History Study | Lead sponsor | Observational | Completed | Epithelioid Sarcoma | 74 | 2021-09-02 |
| 2017-03-27 | NCT03028103 Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients | Lead sponsor | Phase 1 | Completed Results posted | Diffuse Large B Cell Lymphoma; Primary Mediastinal Lymphoma; Mantle Cell Lymphoma; Advanced Solid Tumor; Marginal Zone Lymphoma | 32 | 2019-11-29 |
| 2016-10 | NCT02889523 Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy | Collaborator Lead: The Lymphoma Academic Research Organisation | Phase 1, Phase 2 | Active not recruiting | Lymphoma; DLBCL; Follicular Lymphoma | 214 | 2029-09 |
| 2016-08-30 | NCT02875548 A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study | Lead sponsor | Phase 1, Phase 2 | Completed | Diffuse Large B-cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Synovial Sarcoma; Epitheliod Sarcoma (ES); Mesothelioma; Advanced Solid Tumors; Renal Medullary Carcinoma; Non-Hodgkin Lymphoma (NHL) | 58 | 2025-09-26 |
| 2016-07 | NCT02860286 Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma | Lead sponsor | Phase 2 | Completed Results posted | Mesothelioma; BAP1 Loss of Function | 74 | 2019-05 |
| 2016-01-07 | NCT02601937 EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma | Lead sponsor | Phase 1 | Completed Results posted | Rhabdoid Tumors; INI1-negative Tumors; Synovial Sarcoma; Malignant Rhabdoid Tumor of Ovary | 109 | 2021-10-22 |
| 2015-12-22 | NCT02601950 A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma | Lead sponsor | Phase 2 | Completed Results posted | Malignant Rhabdoid Tumors (MRT); Rhabdoid Tumors of the Kidney (RTK); Atypical Teratoid Rhabdoid Tumors (ATRT); Selected Tumors With Rhabdoid Features; Synovial Sarcoma; INI1-negative Tumors; Malignant Rhabdoid Tumor of Ovary; Renal Medullary Carcinoma; Epithelioid Sarcoma; Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval); Any Solid Tumor With an EZH2 GOF Mutation | 267 | 2024-02-26 |
| 2014-05 | NCT02141828 A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene | Lead sponsor | Phase 1 | Completed | Leukemia; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Acute Leukemias | 18 | 2016-06 |
| 2013-06-13 | NCT01897571 Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | B-cell Lymphomas (Phase 1); Advanced Solid Tumors (Phase 1); Diffuse Large B-cell Lymphoma (Phase 2); Follicular Lymphoma (Phase 2); Transformed Follicular Lymphoma; Primary Mediastinal Large B-Cell Lymphoma | 400 | 2021-11-02 |
| 2012-09 | NCT01684150 A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving | Lead sponsor | Phase 1 | Completed | Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Myeloproliferative Disorders | 51 | 2016-02 |
| NCT04225429 Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma | Lead sponsor | Expanded_access | No longer available | Epithelioid Sarcoma | |||
| NCT03874455 Tazemetostat Expanded Access Program for Adults With Solid Tumors | Lead sponsor | Expanded_access | No longer available | Epithelioid Sarcoma (Ex-US Only); Spindle Cell Sarcoma; Sinonasal Carcinoma; Small Cell Carcinoma of the Ovary Hypercalcemic Type; Thoracic Sarcoma; Poorly Differentiated Chordoma; ATRT; Malignant Rhabdoid Tumor of Kidney; Malignant Rhabdoid Tumor of Ovary; Malignant Rhabdoid Tumor; Myxoid Spindle Cell Sarcoma; Epithelioid Malignant Peripheral Nerve Sheath Tumor; Chondrosarcoma; Renal Cell Carcinoma; Myoepithelial Carcinoma; Synovial Sarcoma; Renal Medullary Carcinoma; Malignant Mesothelioma; Desmoplastic Small Round Cell Tumor (DSRCT); Intramedullary Spinal Cord Schwannomatosis |