TriangleNCT02554812 · OUTCOME
Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
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 6.5 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 A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 28 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 27 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 28 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 34 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 11 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 11 |
Reported measurements
Participants with any grade >= 3 Anemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >=3 Lymphocyte Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 7 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 6 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 6 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 2 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Neutrophil Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 Platelet Count Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Participants with any grade >= 3 White Blood Cell Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Participants with any grade >= 3 Anemia
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- title
- Participants with any grade >=3 Lymphocyte Count Decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Participants with any grade >= 3 Neutrophil Count Decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- 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
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Participants with any grade >= 3 White Blood Cell Decreased
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 34
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 11
- 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 Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
- id
- OG000
- title
- Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
- description
- During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG001
- title
- Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
- description
- During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG002
- title
- Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
- description
- During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG003
- title
- Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG004
- title
- Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG005
- title
- Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG006
- title
- Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG007
- title
- Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
- id
- OG008
- title
- Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
- description
- During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
- id
- OG009
- title
- Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
- 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 6.5 years)
- title
- Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice