NCT03598998 · OUTCOME
Number of Participants Who Had Complete Response (CR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 43 months after the initial study treatment.
What was measured
Number of participants who had a documented complete response at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.
Groups in this outcome
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2 | 7 |
| Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Number of participants who had a documented complete response at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.
- groups
- description
- Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
- description
- Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 43 months after the initial study treatment.
- title
- Number of Participants Who Had Complete Response (CR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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