TriangleNCT02858310 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From the time of cell infusion (Day 0) until documented progressive disease; a maximum of 12 months
What was measured
Progression-free survival is the time from start of treatment to disease progression or death from any cause. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease progression 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.
Analysis population: 24/224 participants were analyzed because 200 were not evaluable for this outcome.
Groups in this outcome
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
Participants Enrolled But Were Not Treated
Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
| Group | Source count |
|---|---|
| Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 2 |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 3 |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 6 |
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 13 |
| Participants Enrolled But Were Not Treated | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 5.5 | Not reported | 3 | 8 | Not reported |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 4 | Not reported | 1 | 9 | Not reported |
| Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 3.5 | Not reported | 1 | 8 | Not reported |
| Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 2 | Not reported | 1 | 12 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 8
- value
- 5.5
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 9
- value
- 4
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 8
- value
- 3.5
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 12
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- Progression-free survival is the time from start of treatment to disease progression or death from any cause. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease progression 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.
- dispersion Type
- Full Range
- groups
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- OG000
- title
- Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
- id
- OG001
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
- description
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
- id
- OG002
- title
- Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells
- description
- Phase II Cohort; Arm 2: Phase II; 1 x 10\^11 E7 Cells that were determined in Phase I + Aldesleukin.
- id
- OG003
- title
- Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells
- description
- Participants were enrolled but were not treated and not assigned to Arm/Cohorts.
- id
- OG004
- title
- Participants Enrolled But Were Not Treated
- param Type
- MEDIAN
- population Description
- 24/224 participants were analyzed because 200 were not evaluable for this outcome.
- reporting Status
- POSTED
- time Frame
- From the time of cell infusion (Day 0) until documented progressive disease; a maximum of 12 months
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice