Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00441337 · OUTCOME

Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population

A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies · Source last updated 2015-02-20

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

Measure
MEDIAN
Unit
percentage of total PSA level
Interval / dispersion
Full Range
Time frame
Day 29, Day 57, Day 85

What was measured

PSA relative velocity (PSA RV) was defined as = (d\[PSA\]/dt)/ \[PSA\], where \[PSA\] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured \[PSA\] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.

Analysis population: The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.

Groups in this outcome

0.3 mg/kg Nivolumab

0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.

1 mg/kg Nivolumab

1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.

3 mg/kg Nivolumab

3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.

10 mg/kg Nivolumab

10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.

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

Analysis denominator · Participants

GroupSource count
0.3 mg/kg Nivolumab0
1 mg/kg Nivolumab1
3 mg/kg Nivolumab2
10 mg/kg Nivolumab5

Reported measurements

Cycle 1 Day 29 (n=0, 1, 2, 5)
Values in percentage of total PSA level · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1 mg/kg Nivolumab0.009Not reported0.0090.009Not reported
3 mg/kg Nivolumab-0.007Not reported-0.0170.003Not reported
10 mg/kg Nivolumab-0.015Not reported-0.0400.002Not reported
Cycle 1 Day 57 (n=0, 1, 2, 5)
Values in percentage of total PSA level · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1 mg/kg Nivolumab0.003Not reported0.0030.003Not reported
3 mg/kg Nivolumab-0.009Not reported-0.010-0.008Not reported
10 mg/kg Nivolumab0.001Not reported-0.0360.018Not reported
Cycle 1 Day 85 (n=0, 1, 2, 4)
Values in percentage of total PSA level · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1 mg/kg Nivolumab0.007Not reported0.0070.007Not reported
3 mg/kg Nivolumab0.001Not reported-0.0030.004Not reported
10 mg/kg Nivolumab-0.005Not reported-0.0440.017Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.009
        upper Limit
        0.009
        value
        0.009
      2. group Id
        OG002
        lower Limit
        -0.017
        upper Limit
        0.003
        value
        -0.007
      3. group Id
        OG003
        lower Limit
        -0.040
        upper Limit
        0.002
        value
        -0.015
    title
    Cycle 1 Day 29 (n=0, 1, 2, 5)
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.003
        upper Limit
        0.003
        value
        0.003
      2. group Id
        OG002
        lower Limit
        -0.010
        upper Limit
        -0.008
        value
        -0.009
      3. group Id
        OG003
        lower Limit
        -0.036
        upper Limit
        0.018
        value
        0.001
    title
    Cycle 1 Day 57 (n=0, 1, 2, 5)
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.007
        upper Limit
        0.007
        value
        0.007
      2. group Id
        OG002
        lower Limit
        -0.003
        upper Limit
        0.004
        value
        0.001
      3. group Id
        OG003
        lower Limit
        -0.044
        upper Limit
        0.017
        value
        -0.005
    title
    Cycle 1 Day 85 (n=0, 1, 2, 4)
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      5
    units
    Participants
description
PSA relative velocity (PSA RV) was defined as = (d\[PSA\]/dt)/ \[PSA\], where \[PSA\] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured \[PSA\] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.
dispersion Type
Full Range
groups
  1. description
    0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
    id
    OG000
    title
    0.3 mg/kg Nivolumab
  2. description
    1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
    id
    OG001
    title
    1 mg/kg Nivolumab
  3. description
    3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
    id
    OG002
    title
    3 mg/kg Nivolumab
  4. description
    10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
    id
    OG003
    title
    10 mg/kg Nivolumab
param Type
MEDIAN
population Description
The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.
reporting Status
POSTED
time Frame
Day 29, Day 57, Day 85
title
Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population
type
SECONDARY
unit Of Measure
percentage of total PSA level

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

Preserved source evidence · Not medical advice