TriangleNCT02718417 · OUTCOME
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
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 36 months
What was measured
nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
Analysis population: The immunogenicity analysis set included all participants who had received at least one dose of study drug and who had at least one nAb sample collected for avelumab in the avelumab containing arms. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Groups in this outcome
Immunogenicity: Chemotherapy Followed by Avelumab
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
| Group | Source count |
|---|---|
| Immunogenicity: Chemotherapy Followed by Avelumab | 272 |
| Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab | 328 |
Reported measurements
Never-positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Immunogenicity: Chemotherapy Followed by Avelumab | 256 | Not reported | Not reported | Not reported | Not reported |
| Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab | 282 | Not reported | Not reported | Not reported | Not reported |
Ever-positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Immunogenicity: Chemotherapy Followed by Avelumab | 16 | Not reported | Not reported | Not reported | Not reported |
| Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab | 46 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 282
- title
- Never-positive
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 46
- title
- Ever-positive
- denoms
- counts
- group Id
- OG000
- value
- 272
- group Id
- OG001
- value
- 328
- units
- Participants
- description
- nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm.
- groups
- description
- In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
- id
- OG000
- title
- Immunogenicity: Chemotherapy Followed by Avelumab
- description
- In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
- id
- OG001
- title
- Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The immunogenicity analysis set included all participants who had received at least one dose of study drug and who had at least one nAb sample collected for avelumab in the avelumab containing arms. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to 36 months
- title
- Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice