TriangleNCT03837899 · OUTCOME
Dose-Expansion Phase Only: Disease Control Rate (DCR)
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
- At 16 and 24 Weeks
What was measured
DCR was defined as the percentage of participants who achieved a BOR of unconfirmed CR or PR, respectively, or who had SD. CR was defined as disappearance of all TLs, any pathological lymph nodes selected as TLs with reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum of diameters as long as criteria for PD are not met. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD.
Analysis population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment. Only participants who achieved a BOR were included in the analysis.
Groups in this outcome
SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.
STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
| Group | Source count |
|---|---|
| SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 11 |
| STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 10 |
Reported measurements
Week 16
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 9.1 | Not reported | Not reported | Not reported | Not reported |
| STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 10.0 | Not reported | Not reported | Not reported | Not reported |
Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 9.1 | Not reported | Not reported | Not reported | Not reported |
| STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 10.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9.1
- group Id
- OG001
- value
- 10.0
- title
- Week 16
- categories
- measurements
- group Id
- OG000
- value
- 9.1
- group Id
- OG001
- value
- 10.0
- title
- Week 24
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- DCR was defined as the percentage of participants who achieved a BOR of unconfirmed CR or PR, respectively, or who had SD. CR was defined as disappearance of all TLs, any pathological lymph nodes selected as TLs with reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum of diameters as long as criteria for PD are not met. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD.
- groups
- description
- Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 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
- SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- description
- Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
- id
- OG001
- title
- STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg
- param Type
- NUMBER
- population Description
- The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment. Only participants who achieved a BOR were included in the analysis.
- reporting Status
- POSTED
- time Frame
- At 16 and 24 Weeks
- title
- Dose-Expansion Phase Only: Disease Control Rate (DCR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice