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NCT03513952 · OUTCOME

Objective Response Rate (ORR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.

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)21
Safety Run in Phase7

Reported measurements

Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (CYT107, Atezolizumab)3Not reportedNot reportedNot reportedNot reported
Group 2 (Atezolizumab)4Not reportedNot reportedNot reportedNot reported
Safety Run in Phase0Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (CYT107, Atezolizumab)2Not reportedNot reportedNot reportedNot reported
Group 2 (Atezolizumab)1Not reportedNot reportedNot reportedNot reported
Safety Run in Phase0Not reportedNot reportedNot reportedNot reported
Combined total PR + CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (CYT107, Atezolizumab)5Not reportedNot reportedNot reportedNot reported
Group 2 (Atezolizumab)5Not reportedNot reportedNot reportedNot reported
Safety Run in Phase0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Estimations were done separately in each treatment arm; the difference between treatments was not calculated.
    p Value
    0.428
    p Value Comment
    A one-sided significance level of 0.10 will be considered for the test.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Estimations were done separately in each treatment arm; the difference between treatments was not calculated.
    p Value
    0.428
    p Value Comment
    A one-sided significance level of 0.10 will be considered for the test.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        0
    title
    Partial Response (PR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
    title
    Combined total PR + CR
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      7
    units
    Participants
description
ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 2 years
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice