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NCT02853305 · FLOW

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Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361) · Source last updated 2023-09-08

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

groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    FG000
    title
    Pembrolizumab + ST Chemotherapy (Pembro Combo)
  2. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    FG001
    title
    Pembrolizumab (Pembro)
  3. description
    Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
    id
    FG002
    title
    ST Chemotherapy (Chemo)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        287
      2. group Id
        FG001
        num Subjects
        249
      3. group Id
        FG002
        num Subjects
        300
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        25
      type
      Transferred to Extension Study
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        24
      type
      Did Not Continue on Extension Study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        351
      2. group Id
        FG001
        num Subjects
        307
      3. group Id
        FG002
        num Subjects
        352
      type
      STARTED
    2. achievements
      1. comment
        Includes 2 participants randomized to Pembrolizumab alone
        group Id
        FG000
        num Subjects
        349
      2. group Id
        FG001
        num Subjects
        302
      3. group Id
        FG002
        num Subjects
        342
      type
      Received First Course of Pembrolizumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        0
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        351
      2. group Id
        FG001
        num Subjects
        307
      3. group Id
        FG002
        num Subjects
        352
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
1,010 participants were randomized 1:1:1 to receive pembrolizumab plus chemotherapy, pembrolizumab alone, or chemotherapy alone. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
recruitment Details
Participants with advanced or metastatic urothelial carcinoma were recruited to examine the efficacy and safety of pembrolizumab plus chemotherapy (pembro combo) versus pembrolizumab alone (pembro) or chemotherapy alone (chemo).
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    FG000
    title
    Pembrolizumab + ST Chemotherapy (Pembro Combo)
  2. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    FG001
    title
    Pembrolizumab (Pembro)
  3. description
    Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
    id
    FG002
    title
    ST Chemotherapy (Chemo)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        287
      2. group Id
        FG001
        num Subjects
        249
      3. group Id
        FG002
        num Subjects
        300
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        25
      type
      Transferred to Extension Study
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        24
      type
      Did Not Continue on Extension Study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        351
      2. group Id
        FG001
        num Subjects
        307
      3. group Id
        FG002
        num Subjects
        352
      type
      STARTED
    2. achievements
      1. comment
        Includes 2 participants randomized to Pembrolizumab alone
        group Id
        FG000
        num Subjects
        349
      2. group Id
        FG001
        num Subjects
        302
      3. group Id
        FG002
        num Subjects
        342
      type
      Received First Course of Pembrolizumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        0
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        351
      2. group Id
        FG001
        num Subjects
        307
      3. group Id
        FG002
        num Subjects
        352
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
1,010 participants were randomized 1:1:1 to receive pembrolizumab plus chemotherapy, pembrolizumab alone, or chemotherapy alone. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
recruitment Details
Participants with advanced or metastatic urothelial carcinoma were recruited to examine the efficacy and safety of pembrolizumab plus chemotherapy (pembro combo) versus pembrolizumab alone (pembro) or chemotherapy alone (chemo).

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Preserved source evidence · Not medical advice