TriangleNCT02592551 · OUTCOME
Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg) in Patients Treated With Combination Therapy (MEDI-4736 and Tremelimumab) and Untreated Patients.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- no unit of ratios with same units(%)
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- the untreated group(control) : at day 1, MEDI4736 + Tremelimumab: at a surgery within one to six weeks after treatment (MEDI4736+Tremelimumab) group
What was measured
Tissue biomarker immune response of CD8 and Treg after MEDI-4736 and Tremelimumab, and at day 1 of untread will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The ratios of CD8/Treg are calculated by diving CD8 by Treg.
Groups in this outcome
MEDI4736 + Tremelimumab
8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
Untreated Arm (Control)
4 patients will not receive MEDI4736 or Tremelimumab. no other name: Neither MEDI4736 nor Tremelimumab will be used.
| Group | Source count |
|---|---|
| MEDI4736 + Tremelimumab | 8 |
| Untreated Arm (Control) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI4736 + Tremelimumab | 9.7 | Not reported | 2 | 20.9 | Not reported |
| Untreated Arm (Control) | 4.03 | Not reported | 2.7 | 12.6 | Not reported |
Source statistical analyses
- group Description
- Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.799
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Description
- Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.799
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 20.9
- value
- 9.7
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- 12.6
- value
- 4.03
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Tissue biomarker immune response of CD8 and Treg after MEDI-4736 and Tremelimumab, and at day 1 of untread will be obtained using CytoF (time-of-flight mass cytometry) and/or flow cytometry. The ratios of CD8/Treg are calculated by diving CD8 by Treg.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- 8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
- id
- OG000
- title
- MEDI4736 + Tremelimumab
- description
- 4 patients will not receive MEDI4736 or Tremelimumab. no other name: Neither MEDI4736 nor Tremelimumab will be used.
- id
- OG001
- title
- Untreated Arm (Control)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- the untreated group(control) : at day 1, MEDI4736 + Tremelimumab: at a surgery within one to six weeks after treatment (MEDI4736+Tremelimumab) group
- title
- Ratio of Intratumoral Cytotoxic T Cells to Regulatory T Cells (CD8/Treg) in Patients Treated With Combination Therapy (MEDI-4736 and Tremelimumab) and Untreated Patients.
- type
- SECONDARY
- unit Of Measure
- no unit of ratios with same units(%)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice