Trial Outcomes & Findings for A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy (NCT NCT03029832)
NCT ID: NCT03029832
Last Updated: 2019-05-31
Results Overview
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of \>= 5 millimeter (mm) in the sum of diameters.
TERMINATED
PHASE2
5 participants
Up to approximately 45 months
2019-05-31
Participant Flow
Participant milestones
| Measure |
MOXR0916 Plus Atezolizumab
Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Atezolizumab
Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
MOXR0916 Plus Atezolizumab
Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Atezolizumab
Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Overall Study
Safety Follow-Up Completed
|
2
|
0
|
|
Overall Study
Death due to Disease Progression
|
1
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
1
|
1
|
Baseline Characteristics
A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy
Baseline characteristics by cohort
| Measure |
MOXR0916 Plus Atezolizumab
n=4 Participants
Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Atezolizumab
n=1 Participants
Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Due to early termination, no formal analyses were performed for PFS.
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of \>= 5 millimeter (mm) in the sum of diameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Due to early termination, no formal analyses were performed for OS.
Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Due to early termination, no formal analyses were performed for OR.
OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Due to early termination, no formal analyses were performed for DOR.
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Due to early termination, no formal analyses were performed for time to pain progression, pain palliation and fatigue progression.
The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Due to early termination, no formal analyses were performed for percentage of participants reporting symptom interference with daily living at the time of progression according to the MDASI
The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: The safety population was defined as all participants who have received at least one dose of study medication. Data were collected but are not being summarized due to privacy concerns with the low number of patients analyzed.
An adverse event is any untoward medical occurrence, regardless of causal attribution.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predosePopulation: Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
AUC represents the body's exposure to an administered drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predosePopulation: Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predosePopulation: Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predosePopulation: Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predosePopulation: Due to early termination, no formal analyses were performed for percentage of participants with ATAs to MOXR0916 and Atezolizumab.
ATAs may be produced by the body in response to an administered drug.
Outcome measures
Outcome data not reported
Adverse Events
MOXR0916 Plus Atezolizumab
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 The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER