TriangleNCT02988817 · OUTCOME
Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part
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
- Day 1 through 44.5 months (maximum observed duration)
What was measured
The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions.
Analysis population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
Groups in this outcome
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
| Group | Source count |
|---|---|
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 1 |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 2 |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 2 |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 1 |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 1 |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | 1 |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 4.2 | Not reported | NA | NA | 95% confidence interval was not reached due to an insufficient events being observed. |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 4.1 | Not reported | 2.4 | NA | Upper limit of 95% confidence interval was not reached due to an insufficient events being observed. |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 4.9 | Not reported | 2.6 | NA | Upper limit of 95% confidence interval was not reached due to an insufficient events being observed. |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 3.0 | Not reported | NA | NA | 95% confidence interval was not reached due to an insufficient events being observed. |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | NA | Not reported | 3.0 | NA | Median and upper limit of 95% confidence interval was not reached due to an insufficient events being observed. |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | 3.0 | Not reported | NA | NA | 95% confidence interval was not reached due to an insufficient events being observed. |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 4.9 | Not reported | NA | NA | 95% confidence interval was not reached due to an insufficient events being observed. |
Complete source fields
- classes
- categories
- measurements
- comment
- 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.2
- comment
- Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG002
- lower Limit
- 2.4
- upper Limit
- NA
- value
- 4.1
- comment
- Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG004
- lower Limit
- 2.6
- upper Limit
- NA
- value
- 4.9
- comment
- 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 3.0
- comment
- Median and upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG006
- lower Limit
- 3.0
- upper Limit
- NA
- value
- NA
- comment
- 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- 3.0
- comment
- 95% confidence interval was not reached due to an insufficient events being observed.
- group Id
- OG008
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.9
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- units
- Participants
- description
- The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG000
- title
- Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG001
- title
- Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG002
- title
- Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG003
- title
- Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
- id
- OG004
- title
- Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
- description
- Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG005
- title
- Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG006
- title
- Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
- id
- OG007
- title
- Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
- description
- Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
- id
- OG008
- title
- Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
- param Type
- MEDIAN
- population Description
- The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Day 1 through 44.5 months (maximum observed duration)
- title
- Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice