Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03513952 · OUTCOME

Overall Survival (OS)

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma · Source last updated 2024-07-26

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time interval between start of treatment to death due to any cause, assessed up to 48 months.

What was measured

OS will be summarized using Kaplan-Meier estimates. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment.

Analysis population: The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

Groups in this outcome

Group 1 (CYT107, Atezolizumab)

Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM

Group 2 (Atezolizumab)

Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV

Safety Run in Phase

Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM

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

Analysis denominator · Participants

GroupSource count
Group 1 (CYT107, Atezolizumab)19
Group 2 (Atezolizumab)19
Safety Run in Phase7

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 1 (CYT107, Atezolizumab)9.1Not reported2.6NAThe medians and 95% CIs for OS were calculated based on Kaplan-Meier estimates. Insufficient events to calculate a reliable upper 95% CI.
Group 2 (Atezolizumab)10.4Not reported4.720.7Not reported
Safety Run in Phase4.5Not reported1.19.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The medians and 95% CIs for OS were calculated based on Kaplan-Meier estimates. Insufficient events to calculate a reliable upper 95% CI.
        group Id
        OG000
        lower Limit
        2.6
        upper Limit
        NA
        value
        9.1
      2. group Id
        OG001
        lower Limit
        4.7
        upper Limit
        20.7
        value
        10.4
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        9.8
        value
        4.5
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      7
    units
    Participants
description
OS will be summarized using Kaplan-Meier estimates. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    OG000
    title
    Group 1 (CYT107, Atezolizumab)
  2. description
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    id
    OG001
    title
    Group 2 (Atezolizumab)
  3. description
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    OG002
    title
    Safety Run in Phase
param Type
MEDIAN
population Description
The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
reporting Status
POSTED
time Frame
Time interval between start of treatment to death due to any cause, assessed up to 48 months.
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice