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NCT02443324 · FLOW

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A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer · Source last updated 2024-07-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants with Gastric-GEJ cancer \[Second-Third Line (L)\] received 8 milligrams per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 for every 3 weeks (Q3W) of a 21-day cycle.
    id
    FG000
    title
    Cohort A
  2. description
    Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG001
    title
    Cohort A1
  3. description
    Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG002
    title
    Cohort A2
  4. description
    Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG003
    title
    Cohort B
  5. description
    Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG004
    title
    Cohort C
  6. description
    Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG005
    title
    Cohort D
  7. description
    Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG006
    title
    Cohort E
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        13
      6. group Id
        FG005
        num Subjects
        17
      7. group Id
        FG006
        num Subjects
        10
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      Adverse Event
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Enrolled but Never Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        29
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        28
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        27
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        26
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Phase 1a
    4. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        24
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        26
      type
      Phase 1b
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        8
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        21
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who did not "complete" study were those who discontinued study treatment by the time of study completion.
recruitment Details
This study has Phase 1a (dose-limiting toxicity \[DLT\] observation) and expansion Phase 1b (safety and preliminary efficacy) included participants with 2 dosing schedules: Schedule 1: gastroesophageal junction (GEJ) cancer (Cohorts A, A2) and biliary tract cancer (Cohorts A1); Schedule 2: Gastric-GEJ cancer (Cohort B), nonsmall cell lung cancer (NSCLC) (Cohorts C, E), and urothelial cancer (Cohort D).
Complete source fields
groups
  1. description
    Participants with Gastric-GEJ cancer \[Second-Third Line (L)\] received 8 milligrams per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 for every 3 weeks (Q3W) of a 21-day cycle.
    id
    FG000
    title
    Cohort A
  2. description
    Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG001
    title
    Cohort A1
  3. description
    Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG002
    title
    Cohort A2
  4. description
    Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG003
    title
    Cohort B
  5. description
    Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG004
    title
    Cohort C
  6. description
    Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG005
    title
    Cohort D
  7. description
    Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    FG006
    title
    Cohort E
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        13
      6. group Id
        FG005
        num Subjects
        17
      7. group Id
        FG006
        num Subjects
        10
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      Adverse Event
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Enrolled but Never Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        29
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        28
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        27
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        26
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Phase 1a
    4. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        24
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        26
      type
      Phase 1b
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        8
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        21
      6. group Id
        FG005
        num Subjects
        24
      7. group Id
        FG006
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who did not "complete" study were those who discontinued study treatment by the time of study completion.
recruitment Details
This study has Phase 1a (dose-limiting toxicity \[DLT\] observation) and expansion Phase 1b (safety and preliminary efficacy) included participants with 2 dosing schedules: Schedule 1: gastroesophageal junction (GEJ) cancer (Cohorts A, A2) and biliary tract cancer (Cohorts A1); Schedule 2: Gastric-GEJ cancer (Cohort B), nonsmall cell lung cancer (NSCLC) (Cohorts C, E), and urothelial cancer (Cohort D).

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Preserved source evidence · Not medical advice