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NCT01658878 · OUTCOME

Maximum Observed Serum Concentration (Cmax)

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer · Source last updated 2025-12-24

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)

What was measured

Cmax is the maximum observed serum concentration.

Analysis population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.

Groups in this outcome

Cohort 1 Uninfected HCC

Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1/0.3/1/3/10 mg/kg every 2 weeks

Cohort 1 HCV Infected

Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3/1/3 mg/kg every 2 weeks

Cohort 1 HBV Infected

Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1/0.3/1/3 mg/kg every 2 weeks

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

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC23
Cohort 1 HCV Infected10
Cohort 1 HBV Infected15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC23
Cohort 1 HCV Infected10
Cohort 1 HBV Infected15
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC60.06335.87Not reportedNot reportedNot reported
Cohort 1 HCV Infected19.81109.88Not reportedNot reportedNot reported
Cohort 1 HBV Infected9.82244.81Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC8
Cohort 1 HCV Infected6
Cohort 1 HBV Infected3
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC100.74339.27Not reportedNot reportedNot reported
Cohort 1 HCV Infected23.09130.66Not reportedNot reportedNot reported
Cohort 1 HBV Infected15.54379.81Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        335.87
        value
        60.06
      2. group Id
        OG001
        spread
        109.88
        value
        19.81
      3. group Id
        OG002
        spread
        244.81
        value
        9.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        339.27
        value
        100.74
      2. group Id
        OG001
        spread
        130.66
        value
        23.09
      3. group Id
        OG002
        spread
        379.81
        value
        15.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      15
    units
    Participants
description
Cmax is the maximum observed serum concentration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1/0.3/1/3/10 mg/kg every 2 weeks
    id
    OG000
    title
    Cohort 1 Uninfected HCC
  2. description
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3/1/3 mg/kg every 2 weeks
    id
    OG001
    title
    Cohort 1 HCV Infected
  3. description
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1/0.3/1/3 mg/kg every 2 weeks
    id
    OG002
    title
    Cohort 1 HBV Infected
param Type
GEOMETRIC_MEAN
population Description
All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
reporting Status
POSTED
time Frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)
title
Maximum Observed Serum Concentration (Cmax)
type
SECONDARY
unit Of Measure
ug/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice