TriangleNCT01772004 · OUTCOME
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Dose Escalation: Baseline up to Day 1023
What was measured
irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Analysis population: Safety analysis set included all participants who have received at least 1 dose of study treatment.
Groups in this outcome
Dose Escalation Cohort: Avelumab 1.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
| Group | Source count |
|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 4 |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 13 |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 15 |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 21 |
Reported measurements
Immune-related Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Immune-related Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Immune-related Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 14 | Not reported | Not reported | Not reported | Not reported |
Immune-related Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Immune-related Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- title
- Immune-related Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 14
- title
- Immune-related Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- title
- Immune-related Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to \[\>=\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
- groups
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
- id
- OG000
- title
- Dose Escalation Cohort: Avelumab 1.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG001
- title
- Dose Escalation Cohort: Avelumab 3.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG002
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG003
- title
- Dose Escalation Cohort: Avelumab 20.0 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who have received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Dose Escalation: Baseline up to Day 1023
- title
- Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice