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NCT01658878 · OUTCOME

Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR)

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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of attainment of complete response (CR) or partial response (PR) (up to approximately 144 months)

What was measured

Time to Response (TTR) defined as the time from randomization to the date of the first confirmed CR or PR for Cohort 3, 4 and 6, and from the first dosing date of study medication to the date of the first confirmed CR or PR for cohort 1, 2 and 5. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6 whose best overall response (BOR) is either complete response (CR) or partial response (PR). Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.

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

Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1

Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks

Cohort 2 Uninfected Sorafenib Progressors: Treatment 2

Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks

Cohort 2 HCV Infected: Treatment 3

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

Cohort 2 HBV Infected: Treatment 4

Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks

Cohort 3: Treatment 1

Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks

Cohort 3: Treatment 2

Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day

Cohort 4: Treatment 1

Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks

Cohort 4: Treatment 2

Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks

Cohort 4: Treatment 3

Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks

Cohort 5: Treatment 1

Participants received nivolumab 240 mg every 2 weeks

Cohort 6: Treatment 1

Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily

Cohort 6: Treatment 2

Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily

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 HCC3
Cohort 1 HCV Infected2
Cohort 1 HBV Infected2
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 111
Cohort 2 Uninfected Sorafenib Progressors: Treatment 28
Cohort 2 HCV Infected: Treatment 310
Cohort 2 HBV Infected: Treatment 47
Cohort 3: Treatment 18
Cohort 3: Treatment 24
Cohort 4: Treatment 116
Cohort 4: Treatment 216
Cohort 4: Treatment 315
Cohort 5: Treatment 13
Cohort 6: Treatment 15
Cohort 6: Treatment 210

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC1.41Not reported1.42.8Not reported
Cohort 1 HCV Infected3.15Not reported2.34.0Not reported
Cohort 1 HBV Infected1.99Not reported1.32.7Not reported
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 12.73Not reported1.36.8Not reported
Cohort 2 Uninfected Sorafenib Progressors: Treatment 23.63Not reported2.65.7Not reported
Cohort 2 HCV Infected: Treatment 32.78Not reported1.27.0Not reported
Cohort 2 HBV Infected: Treatment 41.38Not reported1.26.8Not reported
Cohort 3: Treatment 13.50Not reported1.95.7Not reported
Cohort 3: Treatment 22.81Not reported1.95.5Not reported
Cohort 4: Treatment 12.00Not reported1.112.8Not reported
Cohort 4: Treatment 22.58Not reported1.25.5Not reported
Cohort 4: Treatment 32.66Not reported1.28.7Not reported
Cohort 5: Treatment 12.66Not reported1.44.2Not reported
Cohort 6: Treatment 15.13Not reported1.35.7Not reported
Cohort 6: Treatment 24.17Not reported1.38.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        2.8
        value
        1.41
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        4.0
        value
        3.15
      3. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        2.7
        value
        1.99
      4. group Id
        OG003
        lower Limit
        1.3
        upper Limit
        6.8
        value
        2.73
      5. group Id
        OG004
        lower Limit
        2.6
        upper Limit
        5.7
        value
        3.63
      6. group Id
        OG005
        lower Limit
        1.2
        upper Limit
        7.0
        value
        2.78
      7. group Id
        OG006
        lower Limit
        1.2
        upper Limit
        6.8
        value
        1.38
      8. group Id
        OG007
        lower Limit
        1.9
        upper Limit
        5.7
        value
        3.50
      9. group Id
        OG008
        lower Limit
        1.9
        upper Limit
        5.5
        value
        2.81
      10. group Id
        OG009
        lower Limit
        1.1
        upper Limit
        12.8
        value
        2.00
      11. group Id
        OG010
        lower Limit
        1.2
        upper Limit
        5.5
        value
        2.58
      12. group Id
        OG011
        lower Limit
        1.2
        upper Limit
        8.7
        value
        2.66
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      7
    8. group Id
      OG007
      value
      8
    9. group Id
      OG008
      value
      4
    10. group Id
      OG009
      value
      16
    11. group Id
      OG010
      value
      16
    12. group Id
      OG011
      value
      15
    units
    Participants
description
Time to Response (TTR) defined as the time from randomization to the date of the first confirmed CR or PR for Cohort 3, 4 and 6, and from the first dosing date of study medication to the date of the first confirmed CR or PR for cohort 1, 2 and 5. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
dispersion Type
Full Range
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
  4. description
    Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
    id
    OG003
    title
    Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
  5. description
    Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
    id
    OG004
    title
    Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
  6. description
    Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
    id
    OG005
    title
    Cohort 2 HCV Infected: Treatment 3
  7. description
    Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
    id
    OG006
    title
    Cohort 2 HBV Infected: Treatment 4
  8. description
    Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
    id
    OG007
    title
    Cohort 3: Treatment 1
  9. description
    Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
    id
    OG008
    title
    Cohort 3: Treatment 2
  10. description
    Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
    id
    OG009
    title
    Cohort 4: Treatment 1
  11. description
    Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
    id
    OG010
    title
    Cohort 4: Treatment 2
  12. description
    Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
    id
    OG011
    title
    Cohort 4: Treatment 3
param Type
MEDIAN
population Description
All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6 whose best overall response (BOR) is either complete response (CR) or partial response (PR). Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
reporting Status
POSTED
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of attainment of complete response (CR) or partial response (PR) (up to approximately 144 months)
title
Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice