NCT01772004 · OUTCOME
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) · Source last updated 2021-12-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percentage of receptors
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-infusion on Day 1; 48 hours after infusion on Day 3; Pre-infusion on Days 15, 43, and 85
What was measured
Percentage of PD-L1 receptors occupied by avelumab on human lymphocytes (CD3+ T-cells) was assessed by flow cytometry on peripheral blood mononuclear cell (PBMC) samples. Greater than or equal to \[\>=\] 85 percent \[%\] of cell viability was required for reliable receptor occupancy assessment.
Analysis population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "number analyzed" signifies those who were evaluable for this outcome measure at specified time points.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 3 |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 7 |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 4 |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 6 |
|---|
Reported measurements
Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 5 |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 6 |
|---|
Values in Percentage of receptors · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
Day 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 6 |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 5 |
|---|
Values in Percentage of receptors · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 92.5 | 1.99 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 80.1 | 14.43 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 84.7 | 12.83 | Not reported | Not reported | Not reported |
|---|
Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 3 |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 7 |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 4 |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 5 |
|---|
Values in Percentage of receptors · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 75.7 | 22.12 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 90.0 | 8.11 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 93.2 | 1.29 | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 85.0 | 8.73 | Not reported | Not reported | Not reported |
|---|
Day 43
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 1 |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 1 |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 0 |
|---|
Values in Percentage of receptors · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 30.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 96.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 85
Analysis denominator · Participants
| Group | Source count |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 1 |
|---|
| Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 |
|---|
| Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 |
|---|
| Dose Escalation Cohort: Avelumab 20.0 mg/kg | 0 |
|---|
Values in Percentage of receptors · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dose Escalation Cohort: Avelumab 1.0 mg/kg | 19.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 0.0
- value
- 0.0
- group Id
- OG003
- spread
- 0.0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 1.99
- value
- 92.5
- group Id
- OG001
- spread
- 14.43
- value
- 80.1
- group Id
- OG003
- spread
- 12.83
- value
- 84.7
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- units
- Participants
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 22.12
- value
- 75.7
- group Id
- OG001
- spread
- 8.11
- value
- 90.0
- group Id
- OG002
- spread
- 1.29
- value
- 93.2
- group Id
- OG003
- spread
- 8.73
- value
- 85.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- units
- Participants
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- value
- 30.3
- group Id
- OG001
- value
- 96.8
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Day 43
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Day 85
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- Percentage of PD-L1 receptors occupied by avelumab on human lymphocytes (CD3+ T-cells) was assessed by flow cytometry on peripheral blood mononuclear cell (PBMC) samples. Greater than or equal to \[\>=\] 85 percent \[%\] of cell viability was required for reliable receptor occupancy assessment.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "number analyzed" signifies those who were evaluable for this outcome measure at specified time points.
- reporting Status
- POSTED
- time Frame
- Pre-infusion on Day 1; 48 hours after infusion on Day 3; Pre-infusion on Days 15, 43, and 85
- title
- Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
- type
- SECONDARY
- unit Of Measure
- Percentage of receptors
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