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NCT02713529 · OUTCOME

Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab 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 and 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

GroupSource count
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg8
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg7
Part 2, Group 1: CRC MMR-proficient41
Part 2, Group 2: Pancreatic Cancer31
Part 2, Group 3: NSCLC PD-L1 Low, Naïve4
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low19
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High6

Reported measurements

>=1 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg5Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg7Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient39Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer24Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve4Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low13Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High6Not reportedNot reportedNot reportedNot reported
Grade >=3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg2Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg5Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient29Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer9Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low10Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High4Not reportedNot reportedNot reportedNot reported
Grade >=4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg1Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg1Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient5Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer4Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low2Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High2Not reportedNot reportedNot reportedNot reported
Grade >=5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mgNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mgNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Part 2, Group 1: CRC MMR-proficientNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Part 2, Group 2: Pancreatic CancerNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Part 2, Group 3: NSCLC PD-L1 Low, NaïveNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 LowNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 HighNANot reportedNot reportedNot reportedinvestigator misunderstanding of meaning
Serious AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg2Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg2Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient16Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer5Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low3Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High4Not reportedNot reportedNot reportedNot reported
Leading to interruption of PEM
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg1Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg3Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient15Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer6Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low5Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High2Not reportedNot reportedNot reportedNot reported
Leading to discontinuation AMG 820
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient4Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer2Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High3Not reportedNot reportedNot reportedNot reported
---- SAE leading to d/c AMG 820
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient3Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer1Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High2Not reportedNot reportedNot reportedNot reported
----Non-serious AE leading to d/c AMG 820
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient1Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer1Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High1Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of PEM
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient5Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer2Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High3Not reportedNot reportedNot reportedNot reported
---- SAE leading to d/c PEM
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient3Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer1Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High2Not reportedNot reportedNot reportedNot reported
----Non-serious AE leading to d/c PEM
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient2Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer1Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High1Not reportedNot reportedNot reportedNot reported
Fatal TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient1Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer0Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High1Not reportedNot reportedNot reportedNot reported
TEAE related to study procedure/activity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg0Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient9Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer3Not reportedNot reportedNot reportedNot reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0Not reportedNot reportedNot reportedNot reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low2Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        39
      4. group Id
        OG003
        value
        24
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        13
      7. group Id
        OG006
        value
        6
    title
    >=1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        29
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        4
    title
    Grade >=3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        2
    title
    Grade >=4
  4. categories
    1. measurements
      1. comment
        investigator misunderstanding of meaning
        group Id
        OG000
        value
        NA
      2. comment
        investigator misunderstanding of meaning
        group Id
        OG001
        value
        NA
      3. comment
        investigator misunderstanding of meaning
        group Id
        OG002
        value
        NA
      4. comment
        investigator misunderstanding of meaning
        group Id
        OG003
        value
        NA
      5. comment
        investigator misunderstanding of meaning
        group Id
        OG004
        value
        NA
      6. comment
        investigator misunderstanding of meaning
        group Id
        OG005
        value
        NA
      7. comment
        investigator misunderstanding of meaning
        group Id
        OG006
        value
        NA
    title
    Grade >=5
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        4
    title
    Serious AE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        2
    title
    Leading to interruption of PEM
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        3
    title
    Leading to discontinuation AMG 820
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
    title
    ---- SAE leading to d/c AMG 820
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
    title
    ----Non-serious AE leading to d/c AMG 820
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        3
    title
    Leading to discontinuation of PEM
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
    title
    ---- SAE leading to d/c PEM
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
    title
    ----Non-serious AE leading to d/c PEM
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      41
    4. group Id
      OG003
      value
      31
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      19
    7. 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
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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 and Day 1 up to 572 days for Part 2
title
Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice