Trial · NCT04458922
Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma
NCT04458922, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma. Trials, record NCT04458922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04458922
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma
- NCT number
- NCT04458922
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Central Chondrosarcoma, Grade 2, Central Chondrosarcoma, Grade 3, Dedifferentiated Chondrosarcoma, Metastatic Clear Cell Sarcoma of Soft Tissue, Metastatic Primary Central Chondrosarcoma, Unresectable Primary Central Chondrosarcoma
- Interventions
- Atezolizumab, Biopsy Procedure, Biospecimen Collection, Computed Tomography
- First posted
- 2020-07-07
- Last updated
- 2026-07-31
- Results first posted
- 2023-10-23
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 Rates (ORR) | Baseline until confirmation of progressive disease or response (complete or partial) as defined by RECIST v1.1, an average of 4 months. | ORR was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, which involves the following response definitions. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Duration of Response (DOR) or Change in Clinical Symptoms | Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years | Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and/or change in clinical symptoms. Progressive Disease (PD): is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Progression-free Survival (PFS) Time | Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years | PFS is the time interval from start of treatment to documented evidence of disease progression, measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, or death from any cause, whichever comes first. Progressive Disease (PD): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Number of Activated Cluster of Differentiation 8 (CD8+) T Cells Infiltrating the Tumor | Up to 3 years on Cycle 1 Day 1 and Cycle 3 Day 1 | Activated CD8+ T cells will be detected by multiplex immunofluorescence assays and will be defined by the expression of T cell receptor (TCR) activation (Zeta chain phosphorylation) or phosphorylated Zap70 (pY493); CD8+ cells present within the tumor section that are positive for these markers will be quantified. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
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 Rates (ORR) | Baseline until confirmation of progressive disease or response (complete or partial) as defined by RECIST v1.1, an average of 4 months. | percentage of participants | NUMBER | |
| SECONDARY | Duration of Response (DOR) or Change in Clinical Symptoms | Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years | The analysis population was to include all participants with an objective response (complete or partial). Because no objective responses were observed, there was no evaluable population and data were not collected. | ||
| SECONDARY | Progression-free Survival (PFS) Time | Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination, assessed up to 3 years | Months | MEDIAN | |
| SECONDARY | Number of Activated Cluster of Differentiation 8 (CD8+) T Cells Infiltrating the Tumor | Up to 3 years on Cycle 1 Day 1 and Cycle 3 Day 1 | The analysis population includes all participants with a pre-treatment and post-treatment tumor biopsy pair that was evaluable using multiplex immunofluorescent microscopy analysis. | Biomarker-positive cell/mm^2 | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 11 months and 22 days, 8 months and 27 days, and 11 months and 22 days for each Arm/Group respectively. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | Complete Response | 0 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | Complete Response | 0 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | Complete Response | 0 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | Partial Response | 0 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | Partial Response | 0 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | Partial Response | 0 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | Stable Disease | 33.33 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | Stable Disease | 33.33 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | Stable Disease | 33.33 | percentage of participants | |
| Objective Response Rates (ORR) | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | Progressive Disease | 55.56 | percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 9 | |
| Overall Study | STARTED | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 9 | |
| Overall Study | STARTED | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 9 | |
| Overall Study | COMPLETED | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 0 | |
| Overall Study | COMPLETED | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 0 | |
| Overall Study | COMPLETED | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 1 | |
| Overall Study | NOT COMPLETED | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 9 | |
| Overall Study | NOT COMPLETED | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 9 | |
| Overall Study | NOT COMPLETED | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 8 |
Source ClinicalTrials.gov
Adverse events498
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 | Abdominal distension | Gastrointestinal disorders | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 0 | 9 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 1 | 9 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 2 | 9 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 1 | 9 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 1 | 9 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 0 | 9 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 0 | 9 | 0 |
| other | Alanine aminotransferase increased | Investigations | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 2 | 9 | 2 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 1 | 9 |
| Total, all-cause mortality | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 0 | 9 |
| Total, all-cause mortality | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 2 | 9 |
| Total, other adverse events | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 9 | 9 |
| Total, other adverse events | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 8 | 9 |
| Total, other adverse events | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 9 | 9 |
| Total, serious adverse events | Arm 1 Atezolizumab 1200 mg Intravenous (IV) on Day 1, Subgroup 1: Clear Cell Sarcoma (CCS) | 5 | 9 |
| Total, serious adverse events | Arm 1 Atezolizumab 1200 mg IV on Day 1, Subgroup 2: Conventional Chondrosarcoma (CS)(Grade 2 or 3) | 1 | 9 |
| Total, serious adverse events | Arm 1 Atezolizumab 1200 mg Intravenous on Day 1, Subgroup 3: Dedifferentiated Chondrosarcoma (CS) | 6 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT04458922
GET https://conductscience.org/api/trials/v1/NCT04458922/results?page=2