TriangleNCT03837899 · OUTCOME
Dose-Expansion Phase Only: Objective Response Rate (ORR)
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
- From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
What was measured
ORR as per RECIST 1.1 was defined as the percentage of participants with at least 1 investigator-assessed visit response of complete response (CR) or partial response (PR) that was subsequently confirmed on another scan not less than 4 weeks after visit observed response. CR was defined as disappearance of all target lesions (TLs), any pathological lymph nodes selected as TLs with reduction in short axis to \< 10 millimeter (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.
Analysis population: The evaluable for response analysis set is the subset of participants in the FAS who had measurable disease (as per RECIST 1.1) at baseline and had at least 1 follow-up scan measuring all required target lesions and had been followed for at least 3 cycles or measurable disease (as per RECIST 1.1) at baseline and progressed or died in the absence of a follow-up scan.
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 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg | 11.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- ORR as per RECIST 1.1 was defined as the percentage of participants with at least 1 investigator-assessed visit response of complete response (CR) or partial response (PR) that was subsequently confirmed on another scan not less than 4 weeks after visit observed response. CR was defined as disappearance of all target lesions (TLs), any pathological lymph nodes selected as TLs with reduction in short axis to \< 10 millimeter (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.
- 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 evaluable for response analysis set is the subset of participants in the FAS who had measurable disease (as per RECIST 1.1) at baseline and had at least 1 follow-up scan measuring all required target lesions and had been followed for at least 3 cycles or measurable disease (as per RECIST 1.1) at baseline and progressed or died in the absence of a follow-up scan.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
- title
- Dose-Expansion Phase Only: Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice