Trial · NCT03213665
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
NCT03213665, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial). Trials, record NCT03213665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03213665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
- NCT number
- NCT03213665
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Low Grade Glioma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Hodgkin Lymphoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Hodgkin Lymphoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Soft Tissue Sarcoma, Rhabdoid Tumor, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Wilms Tumor
- Interventions
- Tazemetostat
- First posted
- 2017-07-11
- Last updated
- 2026-04-13
- Results first posted
- 2023-04-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From enrollment to the end of treatment, up to 2 years | ORR will be defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. |
| Secondary | Progression-free Survival (PFS) | Up to 6 months from study entry | Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Patients Experiencing Grade 3 or 4 Adverse Events | From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years | Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient. |
| Other | Biomarker Predictors of Response to Tazemetostat | Up to 2 years | Will evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature. |
| Other | Change in Tumor Genomics | Up to 2 years | To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. Will be performed and will be summarized with simple summary statistics and will be descriptive in nature. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | From enrollment to the end of treatment, up to 2 years | Percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | From start of subprotocol treatment to time of progression or death, whichever occurs first, assessed for up to 2 years | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Experiencing Grade 3 or 4 Adverse Events | From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Biomarker Predictors of Response to Tazemetostat | Up to 2 years | |||
| OTHER_PRE_SPECIFIED | Change in Tumor Genomics | Up to 2 years |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Treatment (Tazemetostat) | 5 | 90% Confidence Interval 1 to 20 | Percentage of participants | |
| Progression-free Survival (PFS) | Treatment (Tazemetostat) | 35 | 95% Confidence Interval 15.7 to 55.2 | percentage of participants | |
| Percentage of Patients Experiencing Grade 3 or 4 Adverse Events | Treatment (Tazemetostat) | 90 | 95% Confidence Interval 68.3 to 98.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Tazemetostat) | 20 | |
| Overall Study | COMPLETED | Treatment (Tazemetostat) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Tazemetostat) | 19 |
Source ClinicalTrials.gov
Adverse events125
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Tazemetostat) | 9 | 20 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Treatment (Tazemetostat) | 2 | 20 | |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Palpitations | Cardiac disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Cushingoid | Endocrine disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Endocrine disorders - Other, specify | Endocrine disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Hypothyroidism | Endocrine disorders | Treatment (Tazemetostat) | 1 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Treatment (Tazemetostat) | 2 | 20 |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Tazemetostat) | 7 | 20 |
| Total, other adverse events | Treatment (Tazemetostat) | 16 | 20 |
| Total, serious adverse events | Treatment (Tazemetostat) | 12 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03213665
GET https://conductscience.org/api/trials/v1/NCT03213665/events?page=2