TriangleNCT03513952 · OUTCOME
Clinical Benefit Rate (CBR) Measured by RECIST v1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR (disappearance of all target lesions), PR (\>=30% decrease in the sum of the longest diameter of target lesions), and stable disease (SD) (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters of target lesions) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; CBR = CR + PR + SD. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment.
Analysis population: 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
Stable Disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (CYT107, Atezolizumab) | 2 | Not reported | Not reported | Not reported | Not reported |
| Group 2 (Atezolizumab) | 4 | Not reported | Not reported | Not reported | Not reported |
| Safety Run in Phase | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (CYT107, Atezolizumab) | 3 | Not reported | Not reported | Not reported | Not reported |
| Group 2 (Atezolizumab) | 4 | Not reported | Not reported | Not reported | Not reported |
| Safety Run in Phase | 0 | Not reported | Not reported | Not reported | Not reported |
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (CYT107, Atezolizumab) | 2 | Not reported | Not reported | Not reported | Not reported |
| Group 2 (Atezolizumab) | 1 | Not reported | Not reported | Not reported | Not reported |
| Safety Run in Phase | 0 | Not reported | Not reported | Not reported | Not reported |
Combined total CR + PR + SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (CYT107, Atezolizumab) | 7 | Not reported | Not reported | Not reported | Not reported |
| Group 2 (Atezolizumab) | 9 | Not reported | Not reported | Not reported | Not reported |
| Safety Run in Phase | 2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -36.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.3
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or "equivalence" between treatments. A two-sided significance level of 0.05 will be considered for the test.
- non Inferiority Type
- EQUIVALENCE
- p Value
- 0.702
- param Type
- Risk Difference (RD)
- param Value
- -6.0
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -36.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 24.3
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or "equivalence" between treatments. A two-sided significance level of 0.05 will be considered for the test.
- non Inferiority Type
- EQUIVALENCE
- p Value
- 0.702
- param Type
- Risk Difference (RD)
- param Value
- -6.0
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- title
- Stable Disease (SD)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 2
- title
- Combined total CR + PR + SD
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR (disappearance of all target lesions), PR (\>=30% decrease in the sum of the longest diameter of target lesions), and stable disease (SD) (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters of target lesions) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; CBR = CR + PR + SD. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- 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
- Up to 2 years
- title
- Clinical Benefit Rate (CBR) Measured by RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice