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NCT01658878 · OUTCOME

Number of Participants With Complete Response (CR) 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to approximately 144 months after first dose

What was measured

The number of participants whose best overall response (BOR) is CR in the population of interest. 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.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC1Not reportedNot reportedNot reportedNot reported
Cohort 1 HCV Infected0Not reportedNot reportedNot reportedNot reported
Cohort 1 HBV Infected0Not reportedNot reportedNot reportedNot reported
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 12Not reportedNot reportedNot reportedNot reported
Cohort 2 Uninfected Sorafenib Progressors: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort 2 HCV Infected: Treatment 32Not reportedNot reportedNot reportedNot reported
Cohort 2 HBV Infected: Treatment 44Not reportedNot reportedNot reportedNot reported
Cohort 3: Treatment 11Not reportedNot reportedNot reportedNot reported
Cohort 3: Treatment 21Not reportedNot reportedNot reportedNot reported
Cohort 4: Treatment 14Not reportedNot reportedNot reportedNot reported
Cohort 4: Treatment 24Not reportedNot reportedNot reportedNot reported
Cohort 4: Treatment 31Not reportedNot reportedNot reportedNot reported
Cohort 5: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort 6: Treatment 11Not reportedNot reportedNot reportedNot reported
Cohort 6: Treatment 23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        4
      11. group Id
        OG010
        value
        4
      12. group Id
        OG011
        value
        1
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
The number of participants whose best overall response (BOR) is CR in the population of interest. 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.
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
COUNT_OF_PARTICIPANTS
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 approximately 144 months after first dose
title
Number of Participants With Complete Response (CR) Assessed by Blinded Independent Central Review (BICR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice