Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01953692 · FLOW

Participant flow

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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

groups
  1. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    FG000
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
  2. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG001
    title
    Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
  3. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG002
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
  4. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG003
    title
    Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
  5. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG004
    title
    Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
  6. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    FG005
    title
    Cohort 4C: R/R Follicular Lymphoma (FL)
  7. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    FG006
    title
    Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
  8. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
    id
    FG007
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
  9. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
    id
    FG008
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        20
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      type
      Clinical Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Excluded Medication
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Protocol Violation
    8. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      type
      Study for Cohort 5 Terminated by Sponsor
    9. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        31
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        22
      7. group Id
        FG006
        num Subjects
        42
      8. group Id
        FG007
        num Subjects
        13
      9. group Id
        FG008
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        32
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were enrolled in disease-specific cohorts (C): C1: myelodysplastic syndrome (MDS); C2: multiple myeloma (MM); C3: Hodgkin lymphoma (HL); C4: non-Hodgkin lymphoma consisting of: * 4A: primary mediastinal B-cell lymphoma (PMBCL) * 4B: Non-PMBCL + programmed cell death ligand 1 positive. DLBCL and FL were included in 4C and 4D. The remaining diseases in 4B were classified as "Other" * 4C: follicular lymphoma (FL) * 4D: diffuse large B-cell lymphoma (DLBCL) And C5: DLBCL
recruitment Details
The study included an initial dose determination for Cohort 5 to determine the recommended Phase 2 dose (RP2D) of lenalidomide. Participants started at a dose of 25 mg. The RP2D dose was set at 20 mg and subsequent participants were enrolled at that dose.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    FG000
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
  2. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG001
    title
    Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
  3. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG002
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
  4. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG003
    title
    Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
  5. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    FG004
    title
    Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
  6. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    FG005
    title
    Cohort 4C: R/R Follicular Lymphoma (FL)
  7. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    FG006
    title
    Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
  8. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
    id
    FG007
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
  9. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
    id
    FG008
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        20
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      type
      Clinical Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Excluded Medication
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Protocol Violation
    8. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      type
      Study for Cohort 5 Terminated by Sponsor
    9. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        31
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        22
      7. group Id
        FG006
        num Subjects
        42
      8. group Id
        FG007
        num Subjects
        13
      9. group Id
        FG008
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        18
      7. group Id
        FG006
        num Subjects
        32
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were enrolled in disease-specific cohorts (C): C1: myelodysplastic syndrome (MDS); C2: multiple myeloma (MM); C3: Hodgkin lymphoma (HL); C4: non-Hodgkin lymphoma consisting of: * 4A: primary mediastinal B-cell lymphoma (PMBCL) * 4B: Non-PMBCL + programmed cell death ligand 1 positive. DLBCL and FL were included in 4C and 4D. The remaining diseases in 4B were classified as "Other" * 4C: follicular lymphoma (FL) * 4D: diffuse large B-cell lymphoma (DLBCL) And C5: DLBCL
recruitment Details
The study included an initial dose determination for Cohort 5 to determine the recommended Phase 2 dose (RP2D) of lenalidomide. Participants started at a dose of 25 mg. The RP2D dose was set at 20 mg and subsequent participants were enrolled at that dose.

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

Preserved source evidence · Not medical advice