Trial Outcomes & Findings for Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets (NCT NCT04899921)
NCT ID: NCT04899921
Last Updated: 2024-03-26
Results Overview
Global PFS is defined as the time from random assignment to the earlier of death or documented disease progression in the intracranial or extracranial compartments. The follow-up of patients who have neither died nor progressed will be censored at the date of the last follow-up visit. Disease assessment was based on RECIST 1.1 for all extracranial lesions and modified RECIST 1.1 for all brain lesions. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated,
TERMINATED
PHASE2
1 participants
Participants would be followed up to 5 years.
2024-03-26
Participant Flow
Participant milestones
| Measure |
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1]
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
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Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2]
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity,
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Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Participants would be followed up to 5 years.Population: Terminated with 1 patient enrolled; no data due to patient privacy.
Global PFS is defined as the time from random assignment to the earlier of death or documented disease progression in the intracranial or extracranial compartments. The follow-up of patients who have neither died nor progressed will be censored at the date of the last follow-up visit. Disease assessment was based on RECIST 1.1 for all extracranial lesions and modified RECIST 1.1 for all brain lesions. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated,
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants were followed up to 5 years.Population: Terminated with 1 patient enrolled; no data due to patient privacy.
OS was defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Estimates of OS would be from a PHMC model.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
Intracranial response rate was defined as the proportion of participants who have achieved complete response (CR) or partial response (PR) based on modified RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 5 years.Population: Terminated with 1 patient enrolled; no data due to patient privacy.
Intracranial PFS was defined as the time from first dose of study therapy to documented intracranial progression or death, whichever occurs first. Per modified RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
The extracranial response rate was defined as the proportion of participants who have achieved complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) for all extracranial lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented extracranial progression or date of death from any cause, whichever came first, assessed up to 5 years.Population: Terminated with 1 patient enrolled; no data due to patient privacy.
Extracranial PFS is defined as the time from first dose of study therapy to documented extracranial progression (per RECIST) or death, whichever occurs first. Evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)39 for all extracranial lesions and modified RECIST 1.1 for all brain lesions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
Number of induction cycles was defined as the number of induction cycles administered.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
Number of maintenance cycles was defined as the number of maintenance cycles administered.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
Corticosteroids usage was defined by number of participants who require prednisone ≥1 mg/kg or equivalent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy.
Frequency of clinically-indicated stereotactic radiation therapy to the brain was defined as the number of participants who received on-study brain-directed stereotactic radiation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to end of treatment up to 5 yearsPopulation: Terminated with 1 patient enrolled; no data due to patient privacy."
Frequency of clinically-indicated surgical intervention to the brain was defined as the number of participants who received on-study surgical intervention to the brain.
Outcome measures
Outcome data not reported
Adverse Events
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1]
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2]
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place