TriangleNCT02988817 · OUTCOME
Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Study Days -21 to 1) and EOT visit (Day 1100)
What was measured
Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples.
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 in the expansion part. Participants who had tumor H-scores in membrane or cytoplasm assessed at Baseline and at the end of treatment visit 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 | 1 |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 1 |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 0 |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 1 |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 0 |
| 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 | 0 |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | -8.0 | NA | Not reported | Not reported | Standard deviation was not derived as only one participant was evaluated. |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | -1.0 | NA | Not reported | Not reported | Standard deviation was not derived as only one participant was evaluated. |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | -30.0 | NA | Not reported | Not reported | Standard deviation was not derived as only one participant was evaluated. |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 35.0 | NA | Not reported | Not reported | Standard deviation was not derived as only one participant was evaluated. |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | -14.0 | NA | Not reported | Not reported | Standard deviation was not derived as only one participant was evaluated. |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation was not derived as only one participant was evaluated.
- group Id
- OG000
- spread
- NA
- value
- -8.0
- comment
- Standard deviation was not derived as only one participant was evaluated.
- group Id
- OG001
- spread
- NA
- value
- -1.0
- comment
- Standard deviation was not derived as only one participant was evaluated.
- group Id
- OG003
- spread
- NA
- value
- -30.0
- comment
- Standard deviation was not derived as only one participant was evaluated.
- group Id
- OG005
- spread
- NA
- value
- 35.0
- comment
- Standard deviation was not derived as only one participant was evaluated.
- group Id
- OG006
- spread
- NA
- value
- -14.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- description
- Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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 in the expansion part. Participants who had tumor H-scores in membrane or cytoplasm assessed at Baseline and at the end of treatment visit were evaluated for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline (Study Days -21 to 1) and EOT visit (Day 1100)
- title
- Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice