TriangleNCT02001623 · OUTCOME
Dose Escalation and Expansion Part: Disease Control Rate
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
- 95% Confidence Interval
- Time frame
- At 6, 12, 24 and 36 weeks
What was measured
Disease control rate was defined as the percentage of participants with CR, PR or stable disease (SD) as per investigator assessment per RECIST version 1.1 after 6, 12, 24 and 36 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.
Analysis population: Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
Groups in this outcome
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
Dose Escalation Part: 1.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
Dose Expansion Part: Bladder Cancer
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 |
| Dose Escalation Part: 0.6 mg/kg | 3 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 3 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 6 |
| Dose Expansion Part: Bladder Cancer | 15 |
| Dose Expansion Part: Cervical Cancer | 55 |
| Dose Expansion Part: Endometrial Cancer | 14 |
| Dose Expansion Part: Esophageal Cancer | 15 |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 15 |
| Dose Expansion Part: Ovarian Cancer | 36 |
| Dose Expansion Part: Prostate Cancer | 18 |
Reported measurements
Week 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 67 | Not reported | 9 | 99 | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 100 | Not reported | 29 | 100 | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 67 | Not reported | 9 | 99 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 50 | Not reported | 12 | 88 | Not reported |
| Dose Expansion Part: Bladder Cancer | 47 | Not reported | 21 | 73 | Not reported |
| Dose Expansion Part: Cervical Cancer | 60 | Not reported | 46 | 73 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 64 | Not reported | 35 | 87 | Not reported |
| Dose Expansion Part: Esophageal Cancer | 40 | Not reported | 16 | 68 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 60 | Not reported | 32 | 84 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 72 | Not reported | 55 | 86 | Not reported |
| Dose Expansion Part: Prostate Cancer | 61 | Not reported | 36 | 83 | Not reported |
Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 67 | Not reported | 9 | 99 | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 67 | Not reported | 9 | 99 | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0 | Not reported | 0 | 46 | Not reported |
| Dose Expansion Part: Bladder Cancer | 33 | Not reported | 12 | 62 | Not reported |
| Dose Expansion Part: Cervical Cancer | 47 | Not reported | 34 | 61 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 43 | Not reported | 18 | 71 | Not reported |
| Dose Expansion Part: Esophageal Cancer | 20 | Not reported | 4 | 48 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 13 | Not reported | 2 | 40 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 42 | Not reported | 26 | 59 | Not reported |
| Dose Expansion Part: Prostate Cancer | 28 | Not reported | 10 | 53 | Not reported |
Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0 | Not reported | 0 | 46 | Not reported |
| Dose Expansion Part: Bladder Cancer | 20 | Not reported | 4 | 48 | Not reported |
| Dose Expansion Part: Cervical Cancer | 18 | Not reported | 9 | 31 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 21 | Not reported | 5 | 51 | Not reported |
| Dose Expansion Part: Esophageal Cancer | 7 | Not reported | 0 | 32 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 13 | Not reported | 2 | 40 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 14 | Not reported | 5 | 29 | Not reported |
| Dose Expansion Part: Prostate Cancer | 6 | Not reported | 0 | 27 | Not reported |
Week 36
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 33 | Not reported | 1 | 91 | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 0 | Not reported | 0 | 71 | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0 | Not reported | 0 | 46 | Not reported |
| Dose Expansion Part: Bladder Cancer | 7 | Not reported | 0 | 32 | Not reported |
| Dose Expansion Part: Cervical Cancer | 11 | Not reported | 4 | 22 | Not reported |
| Dose Expansion Part: Endometrial Cancer | 0 | Not reported | 0 | 23 | Not reported |
| Dose Expansion Part: Esophageal Cancer | 0 | Not reported | 0 | 22 | Not reported |
| Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC) | 7 | Not reported | 0 | 32 | Not reported |
| Dose Expansion Part: Ovarian Cancer | 3 | Not reported | 0 | 15 | Not reported |
| Dose Expansion Part: Prostate Cancer | 6 | Not reported | 0 | 27 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG003
- lower Limit
- 9
- upper Limit
- 99
- value
- 67
- group Id
- OG004
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG005
- lower Limit
- 29
- upper Limit
- 100
- value
- 100
- group Id
- OG006
- lower Limit
- 9
- upper Limit
- 99
- value
- 67
- group Id
- OG007
- lower Limit
- 12
- upper Limit
- 88
- value
- 50
- group Id
- OG008
- lower Limit
- 21
- upper Limit
- 73
- value
- 47
- group Id
- OG009
- lower Limit
- 46
- upper Limit
- 73
- value
- 60
- group Id
- OG010
- lower Limit
- 35
- upper Limit
- 87
- value
- 64
- group Id
- OG011
- lower Limit
- 16
- upper Limit
- 68
- value
- 40
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG003
- lower Limit
- 9
- upper Limit
- 99
- value
- 67
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG005
- lower Limit
- 9
- upper Limit
- 99
- value
- 67
- group Id
- OG006
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 46
- value
- 0
- group Id
- OG008
- lower Limit
- 12
- upper Limit
- 62
- value
- 33
- group Id
- OG009
- lower Limit
- 34
- upper Limit
- 61
- value
- 47
- group Id
- OG010
- lower Limit
- 18
- upper Limit
- 71
- value
- 43
- group Id
- OG011
- lower Limit
- 4
- upper Limit
- 48
- value
- 20
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 46
- value
- 0
- group Id
- OG008
- lower Limit
- 4
- upper Limit
- 48
- value
- 20
- group Id
- OG009
- lower Limit
- 9
- upper Limit
- 31
- value
- 18
- group Id
- OG010
- lower Limit
- 5
- upper Limit
- 51
- value
- 21
- group Id
- OG011
- lower Limit
- 0
- upper Limit
- 32
- value
- 7
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 91
- value
- 33
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG005
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG007
- lower Limit
- 0
- upper Limit
- 46
- value
- 0
- group Id
- OG008
- lower Limit
- 0
- upper Limit
- 32
- value
- 7
- group Id
- OG009
- lower Limit
- 4
- upper Limit
- 22
- value
- 11
- group Id
- OG010
- lower Limit
- 0
- upper Limit
- 23
- value
- 0
- group Id
- OG011
- lower Limit
- 0
- upper Limit
- 22
- value
- 0
- title
- Week 36
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 15
- group Id
- OG009
- value
- 55
- group Id
- OG010
- value
- 14
- group Id
- OG011
- value
- 15
- units
- Participants
- description
- Disease control rate was defined as the percentage of participants with CR, PR or stable disease (SD) as per investigator assessment per RECIST version 1.1 after 6, 12, 24 and 36 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
- id
- OG000
- title
- Dose Escalation Part: 0.3 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
- id
- OG001
- title
- Dose Escalation Part: 0.6 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
- id
- OG002
- title
- Dose Escalation Part: 0.9 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
- id
- OG003
- title
- Dose Escalation Part: 1.2 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
- id
- OG004
- title
- Dose Escalation Part: 1.5 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
- id
- OG005
- title
- Dose Escalation Part: 1.8 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG006
- title
- Dose Escalation Part: 2.0 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
- id
- OG007
- title
- Dose Escalation Part: 2.2 mg/kg
- description
- Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG008
- title
- Dose Expansion Part: Bladder Cancer
- description
- Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG009
- title
- Dose Expansion Part: Cervical Cancer
- description
- Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG010
- title
- Dose Expansion Part: Endometrial Cancer
- description
- Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG011
- title
- Dose Expansion Part: Esophageal Cancer
- param Type
- NUMBER
- population Description
- Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
- reporting Status
- POSTED
- time Frame
- At 6, 12, 24 and 36 weeks
- title
- Dose Escalation and Expansion Part: Disease Control Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice