TriangleNCT04576091 · OUTCOME
Locoregional Control
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
A competing risk analysis will be conducted with local failure, distal failure, and death as competing events. The cumulative incidence and 95% confidence interval for local failure will be estimated. Time to each event will be measured from the start of treatment regimen (day 1 pembrolizumab).
Analysis population: Treated patients who were radiologically evaluable.
Groups in this outcome
Treatment (Pembrolizumab, BAY 1895344, SBRT)
Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
| Group | Source count |
|---|---|
| Treatment (Pembrolizumab, BAY 1895344, SBRT) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Pembrolizumab, BAY 1895344, SBRT) | 16.67 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16.67
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- A competing risk analysis will be conducted with local failure, distal failure, and death as competing events. The cumulative incidence and 95% confidence interval for local failure will be estimated. Time to each event will be measured from the start of treatment regimen (day 1 pembrolizumab).
- groups
- description
- Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
- id
- OG000
- title
- Treatment (Pembrolizumab, BAY 1895344, SBRT)
- param Type
- NUMBER
- population Description
- Treated patients who were radiologically evaluable.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Locoregional Control
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice