TriangleNCT02554812 · OUTCOME
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
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
- Baseline up to end of treatment/withdrawal (maximum of 3 years)
What was measured
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
Analysis population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
Groups in this outcome
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
| Group | Source count |
|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 5 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 7 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 7 |
Reported measurements
Participants with any grade >= 3 Anemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >=3 Lymphocyte Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Neutrophil Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Platelet Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 White Blood Cell Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- Participants with any grade >= 3 Anemia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- title
- Participants with any grade >=3 Lymphocyte Count Decreased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Participants with any grade >= 3 Neutrophil Count Decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- title
- Participants with any grade >= 3 Platelet Count Decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Participants with any grade >= 3 White Blood Cell Decreased
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening hematology laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Anemia, lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
- groups
- description
- During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
- id
- OG000
- title
- Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
- description
- During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
- id
- OG001
- title
- Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
- description
- During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
- id
- OG002
- title
- Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment/withdrawal (maximum of 3 years)
- title
- Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice