NCT04637594 · OUTCOME
Treatment-free Interval (Arm B)
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
- From last dose of immune checkpoint inhibitor (ICI) to initiation of a subsequent systemic treatment or death, assessed up to 5 years
What was measured
Treatment-free Interval is the length of time patients are off treatment. A Stratified Cox model will be used to evaluate this outcome.
Analysis population: All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
Groups in this outcome
Arm A (Immune Checkpoint Inhibitor)
CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
Arm B (Immune Checkpoint Inhibitor)
DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
| Group | Source count |
|---|---|
| Arm A (Immune Checkpoint Inhibitor) | 0 |
| Arm B (Immune Checkpoint Inhibitor) | 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
- units
- Participants
- description
- Treatment-free Interval is the length of time patients are off treatment. A Stratified Cox model will be used to evaluate this outcome.
- groups
- description
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- id
- OG000
- title
- Arm A (Immune Checkpoint Inhibitor)
- description
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- id
- OG001
- title
- Arm B (Immune Checkpoint Inhibitor)
- population Description
- All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
- reporting Status
- POSTED
- time Frame
- From last dose of immune checkpoint inhibitor (ICI) to initiation of a subsequent systemic treatment or death, assessed up to 5 years
- title
- Treatment-free Interval (Arm B)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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