TriangleNCT02526017 · OUTCOME
Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/kg Q2W
- Interval / dispersion
- Not reported
- Time frame
- 28 days
What was measured
Using both the incidence of dose limiting toxicities (first 28 days on therapy) as well as overall tolerability and toxicities observed beyond 28 days, the RD was chosen as 4 mg/kg of cabiralizumab + 3 mg/kg nivolumab every 2 weeks to be the dose used in the Phase 1b (dose expansion). No maximum tolerated dose was identified.
Analysis population: Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.
Groups in this outcome
Overall Phase 1a Dose Escalation
Participants received escalating doses of cabiralizumab monotherapy or cabiralizumab in combination with nivolumab.
| Group | Source count |
|---|---|
| Overall Phase 1a Dose Escalation | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Overall Phase 1a Dose Escalation | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- Using both the incidence of dose limiting toxicities (first 28 days on therapy) as well as overall tolerability and toxicities observed beyond 28 days, the RD was chosen as 4 mg/kg of cabiralizumab + 3 mg/kg nivolumab every 2 weeks to be the dose used in the Phase 1b (dose expansion). No maximum tolerated dose was identified.
- groups
- description
- Participants received escalating doses of cabiralizumab monotherapy or cabiralizumab in combination with nivolumab.
- id
- OG000
- title
- Overall Phase 1a Dose Escalation
- param Type
- NUMBER
- population Description
- Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a)
- type
- PRIMARY
- unit Of Measure
- mg/kg Q2W
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice