TriangleNCT03899805 · OUTCOME
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
- proportion of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to 2 years
What was measured
ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Groups in this outcome
Liposarcomas
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
Leiomyosarcomas
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
Undifferentiated Pleomorphic Sarcomas
* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
| Group | Source count |
|---|---|
| Liposarcomas | 20 |
| Leiomyosarcomas | 19 |
| Undifferentiated Pleomorphic Sarcomas | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Liposarcomas | 0.25 | Not reported | 0.104 | 0.456 | Not reported |
| Leiomyosarcomas | 0.47 | Not reported | 0.274 | 0.680 | Not reported |
| Undifferentiated Pleomorphic Sarcomas | 0.56 | Not reported | 0.351 | 0.756 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.104
- upper Limit
- 0.456
- value
- 0.25
- group Id
- OG001
- lower Limit
- 0.274
- upper Limit
- 0.680
- value
- 0.47
- group Id
- OG002
- lower Limit
- 0.351
- upper Limit
- 0.756
- value
- 0.56
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
- id
- OG000
- title
- Liposarcomas
- description
- * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
- id
- OG001
- title
- Leiomyosarcomas
- description
- * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
- id
- OG002
- title
- Undifferentiated Pleomorphic Sarcomas
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Objective Response Rate(ORR)
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice