TriangleNCT03389802 · OUTCOME
Mutation Burden Based on TCR Sequencing
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Clonotyes
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 0 and Days 7, 14, and 21 after the start of treatment
What was measured
Mutation burden as detected by comparing the TCR sequencing of tumor tissue and/or PBMC. Mean numbers of clonotypes were reported by time point with standard deviations.
Analysis population: Only 4 Stratum 2 patients had data available for this analysis.
Groups in this outcome
Stratum 1, Dose Level 1
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 1, Dose Level 2
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 1, Dose Level 3
Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 2, Dose Level 2
Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Stratum 2, Dose Level 3
Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
| Group | Source count |
|---|---|
| Stratum 1, Dose Level 1 | 0 |
| Stratum 1, Dose Level 2 | 0 |
| Stratum 1, Dose Level 3 | 0 |
| Stratum 2, Dose Level 2 | 4 |
| Stratum 2, Dose Level 3 | 0 |
Reported measurements
Day 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2, Dose Level 2 | 54688.25 | 48633.55 | Not reported | Not reported | Not reported |
Day 7
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2, Dose Level 2 | 159239.75 | 47953.53 | Not reported | Not reported | Not reported |
Day 14
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2, Dose Level 2 | 55328.25 | 43692.86 | Not reported | Not reported | Not reported |
Day 21
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2, Dose Level 2 | 127911.25 | 135922.69 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- spread
- 48633.55
- value
- 54688.25
- title
- Day 0
- categories
- measurements
- group Id
- OG003
- spread
- 47953.53
- value
- 159239.75
- title
- Day 7
- categories
- measurements
- group Id
- OG003
- spread
- 43692.86
- value
- 55328.25
- title
- Day 14
- categories
- measurements
- group Id
- OG003
- spread
- 135922.69
- value
- 127911.25
- title
- Day 21
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- Mutation burden as detected by comparing the TCR sequencing of tumor tissue and/or PBMC. Mean numbers of clonotypes were reported by time point with standard deviations.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG000
- title
- Stratum 1, Dose Level 1
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG001
- title
- Stratum 1, Dose Level 2
- description
- Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG002
- title
- Stratum 1, Dose Level 3
- description
- Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG003
- title
- Stratum 2, Dose Level 2
- description
- Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
- id
- OG004
- title
- Stratum 2, Dose Level 3
- param Type
- MEAN
- population Description
- Only 4 Stratum 2 patients had data available for this analysis.
- reporting Status
- POSTED
- time Frame
- Day 0 and Days 7, 14, and 21 after the start of treatment
- title
- Mutation Burden Based on TCR Sequencing
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Clonotyes
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice