NCT01658878 · OUTCOME
Number of Participants With Anti-drug Antibodies (ADA)
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 first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
What was measured
Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment
Analysis population: All treated participants in Cohort 1 and 2 with baseline and at least 1 post-baseline assessment. Pre-specified to be reported for Cohort 1 and 2 only.
Groups in this outcome
Cohort 1 Uninfected HCC: Treatment 1
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 2
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 3
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 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
| Group | Source count |
|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 1 |
| Cohort 1 Uninfected HCC: Treatment 2 | 3 |
| Cohort 1 Uninfected HCC: Treatment 3 | 3 |
| Cohort 1 Uninfected HCC: Treatment 4 | 3 |
| Cohort 1 Uninfected HCC: Treatment 5 | 12 |
| Cohort 1 HCV Infected: Treatment 6 | 3 |
| Cohort 1 HCV Infected: Treatment 7 | 4 |
| Cohort 1 HCV Infected: Treatment 8 | 3 |
| Cohort 1 HBV Infected: Treatment 9 | 5 |
| Cohort 1 HBV Infected: Treatment 10 | 3 |
| Cohort 1 HBV Infected: Treatment 11 | 3 |
| Cohort 1 HBV Infected: Treatment 12 | 4 |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 53 |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 54 |
| Cohort 2 HCV Infected: Treatment 3 | 44 |
| Cohort 2 HBV Infected: Treatment 4 | 50 |
Reported measurements
Baseline ADA Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
ADA Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 18 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 19 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 16 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 7 | Not reported | Not reported | Not reported | Not reported |
ADA Positive [Persistent Positive (PP)]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
ADA Positive [Not PP-Last Sample Positive]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
ADA Positive [Other Positive]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 6 | Not reported | Not reported | Not reported | Not reported |
Neutralizing Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
ADA Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 35 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 35 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 28 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 43 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Baseline ADA Positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- title
- ADA Positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- ADA Positive [Persistent Positive (PP)]
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- ADA Positive [Not PP-Last Sample Positive]
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- ADA Positive [Other Positive]
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Neutralizing Positive
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 3
- title
- ADA Negative
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment
- groups
- description
- Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
- id
- OG000
- title
- Cohort 1 Uninfected HCC: Treatment 1
- description
- Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
- id
- OG001
- title
- Cohort 1 Uninfected HCC: Treatment 2
- description
- Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
- id
- OG002
- title
- Cohort 1 Uninfected HCC: Treatment 3
- description
- Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
- id
- OG003
- title
- Cohort 1 Uninfected HCC: Treatment 4
- description
- Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
- id
- OG004
- title
- Cohort 1 Uninfected HCC: Treatment 5
- description
- Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
- id
- OG005
- title
- Cohort 1 HCV Infected: Treatment 6
- description
- Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
- id
- OG006
- title
- Cohort 1 HCV Infected: Treatment 7
- description
- Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
- id
- OG007
- title
- Cohort 1 HCV Infected: Treatment 8
- description
- Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
- id
- OG008
- title
- Cohort 1 HBV Infected: Treatment 9
- description
- Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
- id
- OG009
- title
- Cohort 1 HBV Infected: Treatment 10
- description
- Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
- id
- OG010
- title
- Cohort 1 HBV Infected: Treatment 11
- description
- Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
- id
- OG011
- title
- Cohort 1 HBV Infected: Treatment 12
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in Cohort 1 and 2 with baseline and at least 1 post-baseline assessment. Pre-specified to be reported for Cohort 1 and 2 only.
- reporting Status
- POSTED
- time Frame
- From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
- title
- Number of Participants With Anti-drug Antibodies (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle