TriangleNCT04432597 · OUTCOME
Phase I: Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- study end, an average of 6 months
What was measured
Phase 1: overall response rate (ORR) accessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1., defined as a complete response or partial response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is 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 is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Analysis population: 10 of 11 participants are evaluable for ORR in Arm 1B.
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 | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Cohort 1, Arm 1A, Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Cohort 1A, Arm 1A, Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Cohort 1, Arm 1B, Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Phase 1: overall response rate (ORR) accessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1., defined as a complete response or partial response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is 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 is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- 10 of 11 participants are evaluable for ORR in Arm 1B.
- reporting Status
- POSTED
- time Frame
- study end, an average of 6 months
- title
- Phase I: Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice