TriangleNCT00441337 · OUTCOME
Percentage of Participants With Disease Control and Major Durable Disease Control
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 to 2 Years
What was measured
Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.
Analysis population: Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.
Groups in this outcome
0.3 mg/kg Nivolumab
0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg/kg Nivolumab
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg/kg Nivolumab
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg/kg Nivolumab
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
| Group | Source count |
|---|---|
| 0.3 mg/kg Nivolumab | 6 |
| 1 mg/kg Nivolumab | 6 |
| 3 mg/kg Nivolumab | 6 |
| 10 mg/kg Nivolumab | 21 |
Reported measurements
Disease Control Rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| 1 mg/kg Nivolumab | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| 3 mg/kg Nivolumab | 50.0 | Not reported | 11.8 | 88.2 | Not reported |
| 10 mg/kg Nivolumab | 38.1 | Not reported | 18.1 | 61.6 | Not reported |
Major Durable Disease Control Rate ≥24 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 0 | Not reported | 0.0 | 45.9 | Not reported |
| 1 mg/kg Nivolumab | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| 3 mg/kg Nivolumab | 33.3 | Not reported | 4.3 | 77.7 | Not reported |
| 10 mg/kg Nivolumab | 4.8 | Not reported | 0.1 | 23.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG002
- lower Limit
- 11.8
- upper Limit
- 88.2
- value
- 50.0
- group Id
- OG003
- lower Limit
- 18.1
- upper Limit
- 61.6
- value
- 38.1
- title
- Disease Control Rate
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG002
- lower Limit
- 4.3
- upper Limit
- 77.7
- value
- 33.3
- group Id
- OG003
- lower Limit
- 0.1
- upper Limit
- 23.8
- value
- 4.8
- title
- Major Durable Disease Control Rate ≥24 weeks
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG000
- title
- 0.3 mg/kg Nivolumab
- description
- 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG001
- title
- 1 mg/kg Nivolumab
- description
- 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG002
- title
- 3 mg/kg Nivolumab
- description
- 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG003
- title
- 10 mg/kg Nivolumab
- param Type
- NUMBER
- population Description
- Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.
- reporting Status
- POSTED
- time Frame
- Day 1 to 2 Years
- title
- Percentage of Participants With Disease Control and Major Durable Disease Control
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice