TriangleNCT02908672 · OUTCOME
Percentage of Participants Positive for Anti-drug Antibodies (ADA) to Atezolizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Pre-infusion Day 1 of Cycles 1-4 (1 Cycle=28 days); at Atezolizumab discontinuation (approximately up to 33 months)
What was measured
Presence of ADAs against atezolizumab during the study relative to the presence of ADAs at baseline. The percentage of ADA-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.
Analysis population: The ADA-evaluable population included participants who received at least one dose of atezolizumab and had ≥ 1 post-baseline ADA result. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Groups in this outcome
Arm B: Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
| Group | Source count |
|---|---|
| Arm B: Atezo + Cobi + Vem | 218 |
Reported measurements
Baseline evaluable participants
| Group | Source count |
|---|---|
| Arm B: Atezo + Cobi + Vem | 208 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B: Atezo + Cobi + Vem | 1.4 | Not reported | Not reported | Not reported | Not reported |
Post-baseline evaluable participants
| Group | Source count |
|---|---|
| Arm B: Atezo + Cobi + Vem | 218 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B: Atezo + Cobi + Vem | 13.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 208
- units
- Participants
- title
- Baseline evaluable participants
- categories
- measurements
- group Id
- OG000
- value
- 13.3
- denoms
- counts
- group Id
- OG000
- value
- 218
- units
- Participants
- title
- Post-baseline evaluable participants
- denoms
- counts
- group Id
- OG000
- value
- 218
- units
- Participants
- description
- Presence of ADAs against atezolizumab during the study relative to the presence of ADAs at baseline. The percentage of ADA-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.
- groups
- description
- Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
- id
- OG000
- title
- Arm B: Atezo + Cobi + Vem
- param Type
- NUMBER
- population Description
- The ADA-evaluable population included participants who received at least one dose of atezolizumab and had ≥ 1 post-baseline ADA result. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Pre-infusion Day 1 of Cycles 1-4 (1 Cycle=28 days); at Atezolizumab discontinuation (approximately up to 33 months)
- title
- Percentage of Participants Positive for Anti-drug Antibodies (ADA) to Atezolizumab
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice