Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment
Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer · Source last updated 2023-01-20
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
Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2
What was measured
TEAEs include any adverse event starting on or after the first dose of AMG 820 or pembrolizumab. Relation to study drugs was determined by the investigator. Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. Errors in the case report form design resulted in investigators misunderstanding the CTCAE definition for severity grade 5. Therefore data are not reported for severity grade 5. Readers are referred to the 'Fatal TEAE' line in the table below for counts of participants who died during the TEAE timeframe.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
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
>=1 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
5
Not reported
Not reported
Not reported
Not reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
7
Not reported
Not reported
Not reported
Not reported
Part 2, Group 1: CRC MMR-proficient
41
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
25
Not reported
Not reported
Not reported
Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
4
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
14
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
6
Not reported
Not reported
Not reported
Not reported
Grade >=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
3
Not reported
Not reported
Not reported
Not reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
5
Not reported
Not reported
Not reported
Not reported
Part 2, Group 1: CRC MMR-proficient
28
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
11
Not reported
Not reported
Not reported
Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
1
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
10
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
6
Not reported
Not reported
Not reported
Not reported
Grade >=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
1
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
5
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
5
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
2
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
2
Not reported
Not reported
Not reported
Not reported
Grade >=5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Part 2, Group 1: CRC MMR-proficient
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Part 2, Group 2: Pancreatic Cancer
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
NA
Not reported
Not reported
Not reported
investigator misunderstanding of meaning
Serious AE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
2
Not reported
Not reported
Not reported
Not reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
2
Not reported
Not reported
Not reported
Not reported
Part 2, Group 1: CRC MMR-proficient
12
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
4
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
3
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
3
Not reported
Not reported
Not reported
Not reported
Leading to interruption of AMG 820
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg
2
Not reported
Not reported
Not reported
Not reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg
3
Not reported
Not reported
Not reported
Not reported
Part 2, Group 1: CRC MMR-proficient
16
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
7
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
5
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
2
Not reported
Not reported
Not reported
Not reported
Leading to discontinuation AMG 820
Values in Participants · Interval/dispersion: Not reported
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
3
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
3
Not reported
Not reported
Not reported
Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
1
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
3
Not reported
Not reported
Not reported
Not reported
---- SAE leading to d/c AMG 820
Values in Participants · Interval/dispersion: Not reported
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
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
0
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
2
Not reported
Not reported
Not reported
Not reported
----Non-serious AE leading to d/c AMG 820
Values in Participants · Interval/dispersion: Not reported
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
1
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
1
Not reported
Not reported
Not reported
Not reported
Leading to discontinuation of PEM
Values in Participants · Interval/dispersion: Not reported
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
4
Not reported
Not reported
Not reported
Not reported
Part 2, Group 2: Pancreatic Cancer
3
Not reported
Not reported
Not reported
Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
1
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
3
Not reported
Not reported
Not reported
Not reported
---- SAE leading to d/c PEM
Values in Participants · Interval/dispersion: Not reported
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
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
0
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
2
Not reported
Not reported
Not reported
Not reported
----Non-serious AE leading to d/c PEM
Values in Participants · Interval/dispersion: Not reported
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
1
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
1
Not reported
Not reported
Not reported
Not reported
Fatal TEAE
Values in Participants · Interval/dispersion: Not reported
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
1
Not reported
Not reported
Not reported
Not reported
TEAE related to study procedure/activity
Values in Participants · Interval/dispersion: Not reported
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
8
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
3
Not reported
Not reported
Not reported
Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
41
group Id
OG003
value
25
group Id
OG004
value
4
group Id
OG005
value
14
group Id
OG006
value
6
title
>=1 TEAE
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
28
group Id
OG003
value
11
group Id
OG004
value
1
group Id
OG005
value
10
group Id
OG006
value
6
title
Grade >=3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
5
group Id
OG003
value
5
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
2
title
Grade >=4
categories
measurements
comment
investigator misunderstanding of meaning
group Id
OG000
value
NA
comment
investigator misunderstanding of meaning
group Id
OG001
value
NA
comment
investigator misunderstanding of meaning
group Id
OG002
value
NA
comment
investigator misunderstanding of meaning
group Id
OG003
value
NA
comment
investigator misunderstanding of meaning
group Id
OG004
value
NA
comment
investigator misunderstanding of meaning
group Id
OG005
value
NA
comment
investigator misunderstanding of meaning
group Id
OG006
value
NA
title
Grade >=5
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
12
group Id
OG003
value
4
group Id
OG004
value
0
group Id
OG005
value
3
group Id
OG006
value
3
title
Serious AE
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
16
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
5
group Id
OG006
value
2
title
Leading to interruption of AMG 820
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
3
title
Leading to discontinuation AMG 820
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
2
title
---- SAE leading to d/c AMG 820
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
1
group Id
OG005
value
0
group Id
OG006
value
1
title
----Non-serious AE leading to d/c AMG 820
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
3
title
Leading to discontinuation of PEM
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
2
title
---- SAE leading to d/c PEM
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
1
group Id
OG005
value
0
group Id
OG006
value
1
title
----Non-serious AE leading to d/c PEM
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
TEAEs include any adverse event starting on or after the first dose of AMG 820 or pembrolizumab. Relation to study drugs was determined by the investigator. Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. Errors in the case report form design resulted in investigators misunderstanding the CTCAE definition for severity grade 5. Therefore data are not reported for severity grade 5. Readers are referred to the 'Fatal TEAE' line in the table below for counts of participants who died during the TEAE timeframe.
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
Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2
title
Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment