TriangleNCT04432597 · OUTCOME
Phase I: Number of Participants With Dose-Limiting Toxicities (DLT)
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
- Dose-Limiting Toxicities (DLT) were monitored/assessed from the time of first drug administration through 28 days after starting the trial treatment.
What was measured
DLT is defined as any one of the following adverse events, possibly attributable to study drugs, that occur within 28 days of the human papillomavirus (HPV) vaccine monotherapy or 28 days of starting the HPV vaccine + M7824 (MSB0011359C) combination therapy: any grade 3 or higher bleeding episode requiring blood transfusion(s); Any Grade 4 or \> adverse drug reactions (ADRs) as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and assessed as possibly related to any agent by the Investigator, except for laboratory values that are asymptomatic or resolve to Grade ≤ 1 or baseline grade within 7 days without medical intervention; discontinuation any Grade 3 ADRs possibly attributed to any agent except for any of the following: Grade 3 flu-like symptoms or fever, as well as associated symptoms of fatigue, headaches, nausea, emesis which can be controlled with conservative medical management. See Protocol for details.
Analysis population: DLTs evaluable for 3 participants enrolled in each dose level in Arm 1A and 6 participants in Arm 1B of phase I part of the study.
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 | 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 | 1 | 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
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- DLT is defined as any one of the following adverse events, possibly attributable to study drugs, that occur within 28 days of the human papillomavirus (HPV) vaccine monotherapy or 28 days of starting the HPV vaccine + M7824 (MSB0011359C) combination therapy: any grade 3 or higher bleeding episode requiring blood transfusion(s); Any Grade 4 or \> adverse drug reactions (ADRs) as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and assessed as possibly related to any agent by the Investigator, except for laboratory values that are asymptomatic or resolve to Grade ≤ 1 or baseline grade within 7 days without medical intervention; discontinuation any Grade 3 ADRs possibly attributed to any agent except for any of the following: Grade 3 flu-like symptoms or fever, as well as associated symptoms of fatigue, headaches, nausea, emesis which can be controlled with conservative medical management. See Protocol for details.
- 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
- DLTs evaluable for 3 participants enrolled in each dose level in Arm 1A and 6 participants in Arm 1B of phase I part of the study.
- reporting Status
- POSTED
- time Frame
- Dose-Limiting Toxicities (DLT) were monitored/assessed from the time of first drug administration through 28 days after starting the trial treatment.
- title
- Phase I: Number of Participants With Dose-Limiting Toxicities (DLT)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice