TriangleNCT04432597 · OUTCOME
Phase I: Progression-free Survival Time (PFS)
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
- Date of first treatment to date of disease progression or death (any cause), an average of 6 months
What was measured
PFS, evaluated using Kaplan-Meier methods, defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.
Groups in this outcome
Phase I Cohort 1, Arm 1A, Dose Level 1
Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\^11 Viral Particles (VP).
Phase I Cohort 1A, Arm 1A, Dose Level 2
Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\^11 Viral Particles (VP).
Phase I Cohort 1, Arm 1B, Dose Level 2
Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. HPV vaccine at 5x10\^11 Viral Particles (VP).
| Group | Source count |
|---|---|
| Phase I Cohort 1, Arm 1A, Dose Level 1 | 3 |
| Phase I Cohort 1A, Arm 1A, Dose Level 2 | 3 |
| Phase I Cohort 1, Arm 1B, Dose Level 2 | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Cohort 1, Arm 1A, Dose Level 1 | 3.6 | Not reported | 2.3 | 16.8 | Not reported |
| Phase I Cohort 1A, Arm 1A, Dose Level 2 | 1.8 | Not reported | 1.8 | 3.6 | Not reported |
| Phase I Cohort 1, Arm 1B, Dose Level 2 | 1.8 | Not reported | 0.5 | 18.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- 16.8
- value
- 3.6
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 3.6
- value
- 1.8
- group Id
- OG002
- lower Limit
- 0.5
- upper Limit
- 18.1
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- units
- Participants
- description
- PFS, evaluated using Kaplan-Meier methods, defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.
- dispersion Type
- Full Range
- groups
- description
- Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\^11 Viral Particles (VP).
- id
- OG000
- title
- Phase I Cohort 1, Arm 1A, Dose Level 1
- description
- Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\^11 Viral Particles (VP).
- id
- OG001
- title
- Phase I Cohort 1A, Arm 1A, Dose Level 2
- description
- Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. HPV vaccine at 5x10\^11 Viral Particles (VP).
- id
- OG002
- title
- Phase I Cohort 1, Arm 1B, Dose Level 2
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Date of first treatment to date of disease progression or death (any cause), an average of 6 months
- title
- Phase I: Progression-free Survival Time (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice