TriangleNCT04432597 · OUTCOME
Phase II: Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Pre-Treatment (Baseline) and anytime between Week 4-5 post treatment
What was measured
CD3+ tumor infiltrating T cells post treatment compared with pre-treatment reported with a 95% confidence interval assessed by multiplex CD3+ tumor infiltrating lymphocytes assessed by multiplex immunofluorescence from the surgical/ biopsy tissue collected pre- and post-treatment. The percentage of participants with doubling of baseline CD3+ tumor infiltrating lymphocytes will be provided as well as the 95% confidence interval. The CD3 cells are assessed by multiplex immunofluorescence in the biopsies. Doubling is the desired outcome.
Analysis population: 16/22 participants were evaluable because they received two treatments and had adequate biopsies.
Groups in this outcome
Phase II Cohort 2, Arm 2A, Dose Level 2
Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).
| Group | Source count |
|---|---|
| Phase II Cohort 2, Arm 2A, Dose Level 2 | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Cohort 2, Arm 2A, Dose Level 2 | 12.5 | Not reported | 3.5 | 36.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 36.0
- value
- 12.5
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- CD3+ tumor infiltrating T cells post treatment compared with pre-treatment reported with a 95% confidence interval assessed by multiplex CD3+ tumor infiltrating lymphocytes assessed by multiplex immunofluorescence from the surgical/ biopsy tissue collected pre- and post-treatment. The percentage of participants with doubling of baseline CD3+ tumor infiltrating lymphocytes will be provided as well as the 95% confidence interval. The CD3 cells are assessed by multiplex immunofluorescence in the biopsies. Doubling is the desired outcome.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).
- id
- OG000
- title
- Phase II Cohort 2, Arm 2A, Dose Level 2
- param Type
- NUMBER
- population Description
- 16/22 participants were evaluable because they received two treatments and had adequate biopsies.
- reporting Status
- POSTED
- time Frame
- Pre-Treatment (Baseline) and anytime between Week 4-5 post treatment
- title
- Phase II: Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice