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NCT01658878 · OUTCOME

Time to Progression (TTP) 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
95% Confidence Interval
Time frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)

What was measured

Time to Progression (TTP) is defined from the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of the first objectively documented disease progression. Participants who have not progressed as assessed by radiography will be censored at the last tumor assessment date prior to subsequent anti-cancer therapy. Participants who have no on-study tumor assessments were censored at the date of randomization. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Analysis population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. 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 HCC23
Cohort 1 HCV Infected10
Cohort 1 HBV Infected15
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 156
Cohort 2 Uninfected Sorafenib Progressors: Treatment 257
Cohort 2 HCV Infected: Treatment 350
Cohort 2 HBV Infected: Treatment 451
Cohort 3: Treatment 161
Cohort 3: Treatment 266
Cohort 4: Treatment 150
Cohort 4: Treatment 249
Cohort 4: Treatment 349
Cohort 5: Treatment 149
Cohort 6: Treatment 136
Cohort 6: Treatment 235

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC2.66Not reported1.384.21Not reported
Cohort 1 HCV Infected8.21Not reported1.31NAInsufficient number of events to calculate UL
Cohort 1 HBV Infected2.96Not reported1.256.97Not reported
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 14.01Not reported2.764.63Not reported
Cohort 2 Uninfected Sorafenib Progressors: Treatment 22.79Not reported1.485.59Not reported
Cohort 2 HCV Infected: Treatment 33.94Not reported2.638.05Not reported
Cohort 2 HBV Infected: Treatment 42.63Not reported1.384.04Not reported
Cohort 3: Treatment 14.83Not reported1.945.55Not reported
Cohort 3: Treatment 24.63Not reported3.3212.94Not reported
Cohort 4: Treatment 14.27Not reported2.639.69Not reported
Cohort 4: Treatment 21.68Not reported1.3513.90Not reported
Cohort 4: Treatment 32.73Not reported1.455.65Not reported
Cohort 5: Treatment 12.79Not reported1.415.36Not reported
Cohort 6: Treatment 15.42Not reported2.7611.47Not reported
Cohort 6: Treatment 211.63Not reported4.1136.86Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.38
        upper Limit
        4.21
        value
        2.66
      2. comment
        Insufficient number of events to calculate UL
        group Id
        OG001
        lower Limit
        1.31
        upper Limit
        NA
        value
        8.21
      3. group Id
        OG002
        lower Limit
        1.25
        upper Limit
        6.97
        value
        2.96
      4. group Id
        OG003
        lower Limit
        2.76
        upper Limit
        4.63
        value
        4.01
      5. group Id
        OG004
        lower Limit
        1.48
        upper Limit
        5.59
        value
        2.79
      6. group Id
        OG005
        lower Limit
        2.63
        upper Limit
        8.05
        value
        3.94
      7. group Id
        OG006
        lower Limit
        1.38
        upper Limit
        4.04
        value
        2.63
      8. group Id
        OG007
        lower Limit
        1.94
        upper Limit
        5.55
        value
        4.83
      9. group Id
        OG008
        lower Limit
        3.32
        upper Limit
        12.94
        value
        4.63
      10. group Id
        OG009
        lower Limit
        2.63
        upper Limit
        9.69
        value
        4.27
      11. group Id
        OG010
        lower Limit
        1.35
        upper Limit
        13.90
        value
        1.68
      12. group Id
        OG011
        lower Limit
        1.45
        upper Limit
        5.65
        value
        2.73
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      56
    5. group Id
      OG004
      value
      57
    6. group Id
      OG005
      value
      50
    7. group Id
      OG006
      value
      51
    8. group Id
      OG007
      value
      61
    9. group Id
      OG008
      value
      66
    10. group Id
      OG009
      value
      50
    11. group Id
      OG010
      value
      49
    12. group Id
      OG011
      value
      49
    units
    Participants
description
Time to Progression (TTP) is defined from the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of the first objectively documented disease progression. Participants who have not progressed as assessed by radiography will be censored at the last tumor assessment date prior to subsequent anti-cancer therapy. Participants who have no on-study tumor assessments were censored at the date of randomization. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
dispersion Type
95% Confidence Interval
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. 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) up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
title
Time to Progression (TTP) Assessed by Blinded Independent Central Review (BICR)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice