TriangleNCT04895735 · OUTCOME
Clinical Benefit Rate (CBR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 24 weeks
What was measured
CBR will be defined as the rate of patients with stable disease, partial response or complete response as their best response during treatment.
Groups in this outcome
Cohort A
Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Cohort A1
Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Cohort B (Non-adenoid Cystic Carcinoma)
Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
| Group | Source count |
|---|---|
| Cohort A | 11 |
| Cohort A1 | 9 |
| Cohort B (Non-adenoid Cystic Carcinoma) | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 0.727 | Not reported | 0.390 | 0.940 | Not reported |
| Cohort A1 | 1.0 | Not reported | 0.664 | 1.0 | Not reported |
| Cohort B (Non-adenoid Cystic Carcinoma) | 0.583 | Not reported | 0.366 | 0.779 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.390
- upper Limit
- 0.940
- value
- 0.727
- group Id
- OG001
- lower Limit
- 0.664
- upper Limit
- 1.0
- value
- 1.0
- group Id
- OG002
- lower Limit
- 0.366
- upper Limit
- 0.779
- value
- 0.583
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 24
- units
- Participants
- description
- CBR will be defined as the rate of patients with stable disease, partial response or complete response as their best response during treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- id
- OG000
- title
- Cohort A
- description
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- id
- OG001
- title
- Cohort A1
- description
- Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
- id
- OG002
- title
- Cohort B (Non-adenoid Cystic Carcinoma)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 24 weeks
- title
- Clinical Benefit Rate (CBR)
- type
- PRIMARY
- unit Of Measure
- proportion of patients
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Preserved source evidence · Not medical advice