TriangleNCT02526017 · OUTCOME
Efficacy: Duration of Response (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
Duration of response (DOR) is defined as the time from the date of the first documentation of confirmed response (CR or PR) to the first objective documentation of progressive disease (PD) per RECIST v1.1 per Investigator assessment or to death due to any cause in the absence of documented PD. DOR 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. Progressive Disease (PD): The appearance of one or more new lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: Phase 1b response-evaluable population based on investigator assessment with documented CR or PR. 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 non-small cell lung cancer (NSCLC) with no prior exposure to any programmed cell death 1 (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 squamous cell carcinoma of the head and neck (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 renal cell carcinoma (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: Malignant Glioma
Participants with malignant glioma (GBM) 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) | 2 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 1 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 4 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 4 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 4 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 2 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Malignant Glioma | 0 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve) | 8.9 | Not reported | 7.6 | 10.2 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 16.2 | Not reported | NA | NA | Could not be calculated for a sample size of 1 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | NA | Not reported | NA | NA | Could not be calculated due to the low number of events |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 12.7 | Not reported | 8.0 | 16.4 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 7.3 | Not reported | 3.8 | NA | Could not be calculated due to the low number of events |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | NA | Not reported | 3.7 | NA | Could not be calculated due to the low number of events |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | NA | Not reported | NA | NA | Median could not be calculated due to the low number of events; 95% confidence interval could not be calculated or a sample size of 1 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.6
- upper Limit
- 10.2
- value
- 8.9
- comment
- Could not be calculated for a sample size of 1
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 16.2
- comment
- Could not be calculated due to the low number of events
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 8.0
- upper Limit
- 16.4
- value
- 12.7
- comment
- Could not be calculated due to the low number of events
- group Id
- OG004
- lower Limit
- 3.8
- upper Limit
- NA
- value
- 7.3
- comment
- Could not be calculated due to the low number of events
- group Id
- OG005
- lower Limit
- 3.7
- upper Limit
- NA
- value
- NA
- comment
- Median could not be calculated due to the low number of events; 95% confidence interval could not be calculated or a sample size of 1
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- units
- Participants
- description
- Duration of response (DOR) is defined as the time from the date of the first documentation of confirmed response (CR or PR) to the first objective documentation of progressive disease (PD) per RECIST v1.1 per Investigator assessment or to death due to any cause in the absence of documented PD. DOR 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. Progressive Disease (PD): The appearance of one or more new lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with non-small cell lung cancer (NSCLC) with no prior exposure to any programmed cell death 1 (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 squamous cell carcinoma of the head and neck (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 renal cell carcinoma (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 (GBM) 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: Malignant Glioma
- 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
- Phase 1b response-evaluable population based on investigator assessment with documented CR or PR. 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: Duration of Response (Phase 1b)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice