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NCT02713529 · OUTCOME

Participants With Dose Limiting Toxicities (DLT)

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
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 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

Participants with treatment emergent DLTs
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 mg1Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient3Not reportedNot reportedNot reportedNot reported
Part 2, Group 2: Pancreatic Cancer2Not 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 Low1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High0Not reportedNot reportedNot reportedNot reported
DLT: Autoimmune pancreatitis
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 mg1Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient0Not 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 High0Not reportedNot reportedNot reportedNot reported
DLT: Autoimmune hepatitis
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 mg1Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient0Not 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 High0Not reportedNot reportedNot reportedNot reported
DLT: Cholecystitis
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 mg1Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient0Not 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 High0Not reportedNot reportedNot reportedNot reported
DLT: Electrolyte imbalance
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 mg1Not reportedNot reportedNot reportedNot reported
Part 2, Group 1: CRC MMR-proficient0Not 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 High0Not reportedNot reportedNot reportedNot reported
DLT: Fatigue
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 High0Not reportedNot reportedNot reportedNot reported
DLT: Aspartate aminotransferase increased
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, 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 High0Not reportedNot reportedNot reportedNot reported
DLT: Lipase increased
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-proficient0Not 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 Low1Not reportedNot reportedNot reportedNot reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High0Not reportedNot reportedNot reportedNot reported
DLT: Epilepsy
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-proficient0Not 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 High0Not reportedNot reportedNot reportedNot reported
DLT: Rash generalised
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 High0Not reportedNot reportedNot reportedNot reported
DLT: Rash maculo-papular
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 High0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    Participants with treatment emergent DLTs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Autoimmune pancreatitis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Autoimmune hepatitis
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Cholecystitis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Electrolyte imbalance
  6. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Fatigue
  7. 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
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Aspartate aminotransferase increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    DLT: Lipase increased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Epilepsy
  10. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Rash generalised
  11. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    DLT: Rash maculo-papular
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
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
  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
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