TriangleNCT03644550 · OUTCOME
Duration of Overall Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, an average of 3.1 months
What was measured
The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is defined as disappearance of all target lesions with no evidence of tumor elsewhere. Partial Response (PR) is defined as at least a 30% decrease in the total tumor measurement.
Groups in this outcome
1/LMB- 100+Pembrolizumab
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles. LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1. LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial). Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
| Group | Source count |
|---|---|
| 1/LMB- 100+Pembrolizumab | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1/LMB- 100+Pembrolizumab | 3.1 | Not reported | 2.8 | 11.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 11.7
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is defined as disappearance of all target lesions with no evidence of tumor elsewhere. Partial Response (PR) is defined as at least a 30% decrease in the total tumor measurement.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles. LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1. LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial). Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
- id
- OG000
- title
- 1/LMB- 100+Pembrolizumab
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, an average of 3.1 months
- title
- Duration of Overall Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice