TriangleNCT02526017 · OUTCOME
Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b)
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
- Tumor response was assessed every 8 weeks from first dose for the first 12 months and then every 12 weeks thereafter until end of treatment; maximum duration of treatment was 156 weeks.
What was measured
Objective response rate (ORR) is defined as the percentage of participants with confirmed responses of either complete response (CR) or partial response (PR). Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 by investigator review. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: Response-evaluable population based on investigator assessment included all participants who had a measurable lesion at baseline and had at least 1 post-baseline tumor assessment, or clinical progression, or death. 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) | 29 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 31 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 29 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 68 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 30 |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Malignant Glioma | 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) | 6.9 | Not reported | 0.8 | 22.8 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant) | 3.2 | Not reported | 0.1 | 16.7 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN | 13.8 | Not reported | 3.9 | 31.7 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer | 5.9 | Not reported | 1.6 | 14.4 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer | 13.3 | Not reported | 3.8 | 30.7 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC | 6.7 | Not reported | 0.8 | 22.1 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Malignant Glioma | 0 | Not reported | 0.0 | 11.6 | Not reported |
| Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma | 9.1 | Not reported | 0.2 | 41.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- 22.8
- value
- 6.9
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 16.7
- value
- 3.2
- group Id
- OG002
- lower Limit
- 3.9
- upper Limit
- 31.7
- value
- 13.8
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- 14.4
- value
- 5.9
- group Id
- OG004
- lower Limit
- 3.8
- upper Limit
- 30.7
- value
- 13.3
- group Id
- OG005
- lower Limit
- 0.8
- upper Limit
- 22.1
- value
- 6.7
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 11.6
- value
- 0
- group Id
- OG007
- lower Limit
- 0.2
- upper Limit
- 41.3
- value
- 9.1
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 68
- group Id
- OG004
- value
- 30
- group Id
- OG005
- value
- 30
- group Id
- OG006
- value
- 30
- group Id
- OG007
- value
- 11
- units
- Participants
- description
- Objective response rate (ORR) is defined as the percentage of participants with confirmed responses of either complete response (CR) or partial response (PR). Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 by investigator review. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- 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
- NUMBER
- population Description
- Response-evaluable population based on investigator assessment included all participants who had a measurable lesion at baseline and had at least 1 post-baseline tumor assessment, or clinical progression, or death. Efficacy endpoints were specified to be analyzed by disease type for Phase 1b participants only.
- reporting Status
- POSTED
- time Frame
- Tumor response was assessed every 8 weeks from first dose for the first 12 months and then every 12 weeks thereafter until end of treatment; maximum duration of treatment was 156 weeks.
- title
- Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice