Skip to content
← Full study record

NCT03617913 · OUTCOME

Progression-free Survival

Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer · Source last updated 2023-01-06

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
From registration to time of first documentation of progression or death from any cause, assessed up to 12 months

What was measured

Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.

Analysis population: All patients who registered and were treated are included in this analysis.

Groups in this outcome

Avelumab and Cisplatin IV

Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Avelumab and Cisplatin IV2

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Avelumab and Cisplatin IVNANot reportedNANAToo few events have occurred to obtain a median or a 95% CI.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Too few events have occurred to obtain a median or a 95% CI.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Avelumab and Cisplatin IV
param Type
MEDIAN
population Description
All patients who registered and were treated are included in this analysis.
reporting Status
POSTED
time Frame
From registration to time of first documentation of progression or death from any cause, assessed up to 12 months
title
Progression-free Survival
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice