TriangleNCT03854032 · OUTCOME
Intratumoral Immune Cell Populations, Immune Polarization Data, Exosome Composition, and Exosome Function in Human Papilloma Virus (HPV) + and HPV- Tumors
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 12 months
What was measured
Baseline IHC staining for P16 will be performed as a surrogate for HPV status. If there is at least one significant difference between groups among the primary outcomes, the two randomization arms will be compared with respect to each secondary outcome using two-sample t-tests. P-values for comparisons of changes in secondary outcomes will be adjusted using the method of Benjamini and Hochberg to control the FDR among the secondary outcomes at 5%.
Analysis population: This outcome was not performed. Following early termination of the study by the Sponsor due to toxicity concerns, the planned analysis for this outcome was not pursued. Therefore, no participants were analyzed for this outcome. No additional analyses are planned, and data for this outcome will not be collected or reported in the future.
Groups in this outcome
Arm A: BMS986205 + Nivolumab
Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days. Nivolumab: Given IV IDO1 Inhibitor BMS-986205: Given PO Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
Arm B: Group I - Nivolumab Only
Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days. Nivolumab: Given IV Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
Arm C: Group II - Nivolumab Only
Data from Contemporaneous Study 10237 (NCT03238365) participants who received Nivolumab alone prior to surgery is used as a historical controls under the current window of treatment (WOT), to bolster the control group.
| Group | Source count |
|---|---|
| Arm A: BMS986205 + Nivolumab | 0 |
| Arm B: Group I - Nivolumab Only | 0 |
| Arm C: Group II - Nivolumab Only | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Baseline IHC staining for P16 will be performed as a surrogate for HPV status. If there is at least one significant difference between groups among the primary outcomes, the two randomization arms will be compared with respect to each secondary outcome using two-sample t-tests. P-values for comparisons of changes in secondary outcomes will be adjusted using the method of Benjamini and Hochberg to control the FDR among the secondary outcomes at 5%.
- groups
- description
- Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days. Nivolumab: Given IV IDO1 Inhibitor BMS-986205: Given PO Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Arm A: BMS986205 + Nivolumab
- description
- Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days. Nivolumab: Given IV Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Arm B: Group I - Nivolumab Only
- description
- Data from Contemporaneous Study 10237 (NCT03238365) participants who received Nivolumab alone prior to surgery is used as a historical controls under the current window of treatment (WOT), to bolster the control group.
- id
- OG002
- title
- Arm C: Group II - Nivolumab Only
- population Description
- This outcome was not performed. Following early termination of the study by the Sponsor due to toxicity concerns, the planned analysis for this outcome was not pursued. Therefore, no participants were analyzed for this outcome. No additional analyses are planned, and data for this outcome will not be collected or reported in the future.
- reporting Status
- POSTED
- time Frame
- Up to 12 months
- title
- Intratumoral Immune Cell Populations, Immune Polarization Data, Exosome Composition, and Exosome Function in Human Papilloma Virus (HPV) + and HPV- Tumors
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice