TriangleNCT03513952 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years.
What was measured
Progression is defined, per RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions (the sum must demonstrate an absolute increase of at least 5 mm), or the appearance of new lesions and/or unequivocal progression of non-target lesions. PFS will be summarized using Kaplan-Meier estimates. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment.
Analysis population: Patients without documented PD or death are censored at the last disease assessment date. The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
Groups in this outcome
Group 1 (CYT107, Atezolizumab)
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
| Group | Source count |
|---|---|
| Group 1 (CYT107, Atezolizumab) | 19 |
| Group 2 (Atezolizumab) | 21 |
| Safety Run in Phase | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (CYT107, Atezolizumab) | 2.1 | Not reported | 1.2 | 6.1 | Not reported |
| Group 2 (Atezolizumab) | 2.2 | Not reported | 1.8 | 4.6 | Not reported |
| Safety Run in Phase | 2.1 | Not reported | 1.1 | 4.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 6.1
- value
- 2.1
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 4.6
- value
- 2.2
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 4.0
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- Progression is defined, per RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions (the sum must demonstrate an absolute increase of at least 5 mm), or the appearance of new lesions and/or unequivocal progression of non-target lesions. PFS will be summarized using Kaplan-Meier estimates. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
- id
- OG000
- title
- Group 1 (CYT107, Atezolizumab)
- description
- Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
- id
- OG001
- title
- Group 2 (Atezolizumab)
- description
- Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
- id
- OG002
- title
- Safety Run in Phase
- param Type
- MEDIAN
- population Description
- Patients without documented PD or death are censored at the last disease assessment date. The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
- reporting Status
- POSTED
- time Frame
- Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years.
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice