TriangleNCT02554812 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: 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 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 6.5 years)
What was measured
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per National Cancer Institute (NCI) CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Analysis population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
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 | 29 |
| 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 | 35 |
| 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
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 29 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 27 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 28 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 35 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 20 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 10 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 21 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 11 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 11 | Not reported | Not reported | Not reported | Not reported |
Grade >=3 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 15 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 13 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 18 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 13 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 19 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 9 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 7 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 12 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 6 | Not reported | Not reported | Not reported | Not reported |
Serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 11 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 12 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 13 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 9 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 16 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 1 | Not reported | Not reported | Not reported | Not reported |
Treatment related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 22 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 22 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 25 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 23 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 26 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 15 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 19 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 10 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 35
- group Id
- OG005
- value
- 20
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 11
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 6
- title
- Grade >=3 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 1
- title
- Serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 23
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 19
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 9
- title
- Treatment related TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 35
- 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
- TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per National Cancer Institute (NCI) CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- 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
- The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 6.5 years)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice