Trial Outcomes & Findings for Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer (NCT NCT03455556)
NCT ID: NCT03455556
Last Updated: 2023-01-06
Results Overview
Maximum tolerated dose (MTD) of anetumab ravtansine combined with atezolizumab defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)
TERMINATED
PHASE1
1 participants
Up to 21 days
2023-01-06
Participant Flow
One (1) patient was recruited from August 2018 to September 2019 at Mayo Clinic. This trial was permanently closed on September 11, 2019. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Participant milestones
| Measure |
Treatment (Anetumab Ravtansine, Atezolizumab)
Participants receive 5.5 mg/kg anetumab ravtansine IV over 60 minutes and 1200 mg atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Maximum tolerated dose (MTD) of anetumab ravtansine combined with atezolizumab defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Defined as a patient who has achieved a partial response (PR) or complete response (CR) on two consecutive evaluations at least 4 weeks apart. Will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 21 days after last dosePopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
The number and severity of all adverse events (overall and by dose-level) will be tabulated and summarized in this patient population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year and up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan Meier. Will also report the 1-year progression free survival (PFS) rate for the combination of anetumab ravtansine and atezolizumab in 2nd-line non-small cell lung cancer (NSCLC).
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Anetumab Ravtansine, Atezolizumab)
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