TriangleNCT04432597 · OUTCOME
Phase I: Duration of Response (DOR)
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 4 months
What was measured
Phase 1: DOR is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (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). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. 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 (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 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Cohort 1, Arm 1A, Dose Level 1 | NA | Not reported | NA | NA | No responses observed in Phase 1 Cohort 1, Arm 1A, Dose Level 1, therefore duration of response can't be defined. |
| Phase I Cohort 1A, Arm 1A, Dose Level 2 | NA | Not reported | NA | NA | No responses observed in Phase 1 Cohort 1, Arm 1A, Dose Level 2, therefore duration of response can't be defined. |
| Phase I Cohort 1, Arm 1B, Dose Level 2 | 10.1 | Not reported | 8.0 | 12.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- No responses observed in Phase 1 Cohort 1, Arm 1A, Dose Level 1, therefore duration of response can't be defined.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- No responses observed in Phase 1 Cohort 1, Arm 1A, Dose Level 2, therefore duration of response can't be defined.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 8.0
- upper Limit
- 12.2
- value
- 10.1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Phase 1: DOR is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (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). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. 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 (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 4 months
- title
- Phase I: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice