TriangleNCT02526017 · OUTCOME
Efficacy: Progression Free Survival (Phase 1b)
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 first dose of study drug up to the end of study; maximum time on study in phase 1b was 35.9 months.
What was measured
Progression-free survival (PFS) was defined as as the time from the first dose to the first objectively documented disease progression per RECIST v1.1 per Investigator assessment or death due to any cause in the absence of documented progressive disease (PD). PFS was analyzed using Kaplan-Meier methods. Participants who discontinued from the study, did not die or have disease progression, or who received new anticancer therapy were censored on the date of last evaluable assessment prior to initiation of subsequent therapy. Participants with no evaluable baseline or post-baseline assessments were censored on the date of first dose.
Analysis population: All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only.
Groups in this outcome
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)
Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)
Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN
Participants with SCCHN received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer
Participants with pancreatic cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer
Participants with advanced ovarian cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC
Participants with RCC received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM
Participants with malignant glioma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma
Participants with melanoma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
| Group | Source count |
|---|---|
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 31 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 68 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 31 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 2.8 | Not reported | 1.7 | 4.8 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 1.9 | Not reported | 1.7 | 3.4 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 1.8 | Not reported | 1.4 | 3.8 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 1.7 | Not reported | 1.6 | 1.9 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 2.0 | Not reported | 1.7 | 3.6 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 2.9 | Not reported | 1.8 | 5.5 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM | 1.8 | Not reported | 1.3 | 3.4 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 1.8 | Not reported | 1.1 | 4.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 4.8
- value
- 2.8
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- 3.4
- value
- 1.9
- group Id
- OG002
- lower Limit
- 1.4
- upper Limit
- 3.8
- value
- 1.8
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- 1.9
- value
- 1.7
- group Id
- OG004
- lower Limit
- 1.7
- upper Limit
- 3.6
- value
- 2.0
- group Id
- OG005
- lower Limit
- 1.8
- upper Limit
- 5.5
- value
- 2.9
- group Id
- OG006
- lower Limit
- 1.3
- upper Limit
- 3.4
- value
- 1.8
- group Id
- OG007
- lower Limit
- 1.1
- upper Limit
- 4.9
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 68
- group Id
- OG004
- value
- 31
- group Id
- OG005
- value
- 30
- group Id
- OG006
- value
- 30
- group Id
- OG007
- value
- 11
- units
- Participants
- description
- Progression-free survival (PFS) was defined as as the time from the first dose to the first objectively documented disease progression per RECIST v1.1 per Investigator assessment or death due to any cause in the absence of documented progressive disease (PD). PFS was analyzed using Kaplan-Meier methods. Participants who discontinued from the study, did not die or have disease progression, or who received new anticancer therapy were censored on the date of last evaluable assessment prior to initiation of subsequent therapy. Participants with no evaluable baseline or post-baseline assessments were censored on the date of first dose.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG000
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)
- description
- Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG001
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)
- description
- Participants with SCCHN received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG002
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN
- description
- Participants with pancreatic cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG003
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer
- description
- Participants with advanced ovarian cancer received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG004
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer
- description
- Participants with RCC received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG005
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC
- description
- Participants with malignant glioma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG006
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM
- description
- Participants with melanoma received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- id
- OG007
- title
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma
- param Type
- MEDIAN
- population Description
- All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to the end of study; maximum time on study in phase 1b was 35.9 months.
- title
- Efficacy: Progression Free Survival (Phase 1b)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice