Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04231981 · FLOW

Participant flow

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) · Source last updated 2025-05-29

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

groups
  1. description
    Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
    id
    FG000
    title
    Interventional Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Male patients ≥ 18 years of age. ECOG Performance Status ≤ 1. Life expectancy ≥12 weeks. Histologically-proven PSqCC. Locally advanced unresectable/metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1). - Radiological evidence of locally advanced or metastatic disease. - Adequate organ function.
recruitment Details
Between April 2020 and August 2021, a total of 18 male patients with locally advanced unresectable or metastatic PSqCC stage 4 (i.e. T4 or N3 or M1)presenting radiologic PD and/or chemotherapy were enrolled at 9 sites. Due there's only one arm, all the patients received INCMGA00012 until disease progression, death or discontinuation from the study.
Complete source fields
groups
  1. description
    Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
    id
    FG000
    title
    Interventional Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Male patients ≥ 18 years of age. ECOG Performance Status ≤ 1. Life expectancy ≥12 weeks. Histologically-proven PSqCC. Locally advanced unresectable/metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1). - Radiological evidence of locally advanced or metastatic disease. - Adequate organ function.
recruitment Details
Between April 2020 and August 2021, a total of 18 male patients with locally advanced unresectable or metastatic PSqCC stage 4 (i.e. T4 or N3 or M1)presenting radiologic PD and/or chemotherapy were enrolled at 9 sites. Due there's only one arm, all the patients received INCMGA00012 until disease progression, death or discontinuation from the study.

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

Preserved source evidence · Not medical advice