NCT02713529 · OUTCOME
Participants With Dose Limiting Toxicities (DLT)
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
- The DLT evaluation period was Day 1 to Day 21
What was measured
DLTs were evaluated by the Dose Level Review Team (DLRT). A DLT was defined as any grade \>=3 adverse event occurring during a DLT time window (21 day period from the initial administration of AMG 820 and pembrolizumab in combination), and if judged by the investigator to be related to the administration of AMG 820 and/or pembrolizumab.
Analysis population: Safety Analysis Set
Groups in this outcome
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed. If \>= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg.
Part 2, Group 1: CRC MMR-proficient
Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 2: Pancreatic Cancer
Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\<50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\>=50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
| Group | Source count |
|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 8 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 7 |
| Part 2, Group 1: CRC MMR-proficient | 41 |
| Part 2, Group 2: Pancreatic Cancer | 31 |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 4 |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 19 |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 6 |
Reported measurements
Participants with treatment emergent DLTs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Autoimmune pancreatitis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Autoimmune hepatitis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Cholecystitis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Electrolyte imbalance
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Fatigue
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Aspartate aminotransferase increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Lipase increased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Epilepsy
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Rash generalised
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
DLT: Rash maculo-papular
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- title
- Participants with treatment emergent DLTs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- 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
- title
- DLT: Autoimmune pancreatitis
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- 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
- title
- DLT: Autoimmune hepatitis
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- 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
- title
- DLT: Cholecystitis
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- 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
- title
- DLT: Electrolyte imbalance
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- DLT: Fatigue
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- DLT: Aspartate aminotransferase increased
- 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
- 1
- group Id
- OG006
- value
- 0
- title
- DLT: Lipase increased
- 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
- 0
- group Id
- OG006
- value
- 0
- title
- DLT: Epilepsy
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- DLT: Rash generalised
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- DLT: Rash maculo-papular
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 31
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- DLTs were evaluated by the Dose Level Review Team (DLRT). A DLT was defined as any grade \>=3 adverse event occurring during a DLT time window (21 day period from the initial administration of AMG 820 and pembrolizumab in combination), and if judged by the investigator to be related to the administration of AMG 820 and/or pembrolizumab.
- groups
- description
- Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
- id
- OG000
- title
- Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
- description
- Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed. If \>= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg.
- id
- OG001
- title
- Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
- description
- Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG002
- title
- Part 2, Group 1: CRC MMR-proficient
- description
- Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG003
- title
- Part 2, Group 2: Pancreatic Cancer
- description
- Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG004
- title
- Part 2, Group 3: NSCLC PD-L1 Low, Naïve
- description
- Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\<50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG005
- title
- Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
- description
- Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\>=50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG006
- title
- Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set
- reporting Status
- POSTED
- time Frame
- The DLT evaluation period was Day 1 to Day 21
- title
- Participants With Dose Limiting Toxicities (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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