TriangleNCT03837899 · OUTCOME
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs)
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 on Cycle 1 Day 1 and Cycle 3 Day 1 (durvalumab and tremelimumab), pre-infusion on Cycle 2 Day 1, Cycle 5 Day 1 and Cycle 8 Day 1 for tremelimumab
What was measured
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Analysis population: The ADA analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom baseline, and any post-dose data were available were included in the ADA analysis set. Only data from the participants analyzed were reported.
Groups in this outcome
Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
| Group | Source count |
|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 4 |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 3 |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 1 |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 1 |
Reported measurements
Durvalumab, ADA positive at any visit
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 25 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Durvalumab, Persistently positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Durvalumab, Transiently positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Tremelimumab, ADA positive at any visit
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Tremelimumab, Persistently positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Tremelimumab, Transiently positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Durvalumab, ADA positive at any visit
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Durvalumab, Persistently positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Durvalumab, Transiently positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Tremelimumab, ADA positive at any visit
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Tremelimumab, Persistently positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Tremelimumab, Transiently positive
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
- groups
- description
- Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG000
- title
- Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
- description
- Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG001
- title
- Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- description
- Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG002
- title
- Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg
- description
- Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
- id
- OG003
- title
- Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- param Type
- NUMBER
- population Description
- The ADA analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom baseline, and any post-dose data were available were included in the ADA analysis set. Only data from the participants analyzed were reported.
- reporting Status
- POSTED
- time Frame
- Pre-infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (durvalumab and tremelimumab), pre-infusion on Cycle 2 Day 1, Cycle 5 Day 1 and Cycle 8 Day 1 for tremelimumab
- title
- Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice