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NCT04472429 · FLOW

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Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). · Source last updated 2026-09-02

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

groups
  1. description
    Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
    id
    FG000
    title
    Retifanlimab 500 mg Q4W + Chemotherapy
  2. description
    Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
    id
    FG001
    title
    Placebo + Chemotherapy
  3. description
    In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
    id
    FG002
    title
    Retifanlimab 500 mg Q4W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Inclusion Criterion Not Met on Day of Planned Dose
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      New Diagnosis of Lymphoma
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        0
      type
      Experienced Disease Progression; Transitioned to Retifanlimab Monotherapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        154
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        152
      3. group Id
        FG002
        num Subjects
        0
      type
      Received Study Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        93
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomized Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        54
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        77
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        57
      type
      NOT COMPLETED
    title
    Optional Open-label Monotherapy Period
pre Assignment Details
This study randomized participants at 70 study centers in Australia, Belgium, Germany, Denmark, Spain, France, the United Kingdom, Italy, Japan, Norway, Puerto Rico, Sweden, and the United States.
Complete source fields
groups
  1. description
    Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
    id
    FG000
    title
    Retifanlimab 500 mg Q4W + Chemotherapy
  2. description
    Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
    id
    FG001
    title
    Placebo + Chemotherapy
  3. description
    In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
    id
    FG002
    title
    Retifanlimab 500 mg Q4W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Inclusion Criterion Not Met on Day of Planned Dose
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      New Diagnosis of Lymphoma
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        0
      type
      Experienced Disease Progression; Transitioned to Retifanlimab Monotherapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        154
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        152
      3. group Id
        FG002
        num Subjects
        0
      type
      Received Study Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        93
      2. group Id
        FG001
        num Subjects
        126
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomized Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        54
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        77
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        57
      type
      NOT COMPLETED
    title
    Optional Open-label Monotherapy Period
pre Assignment Details
This study randomized participants at 70 study centers in Australia, Belgium, Germany, Denmark, Spain, France, the United Kingdom, Italy, Japan, Norway, Puerto Rico, Sweden, and the United States.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice