Trial Outcomes & Findings for Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab (NCT NCT02919449)
NCT ID: NCT02919449
Last Updated: 2023-07-21
Results Overview
To determine the maximum tolerated dose (MTD) of the intra-tumoral administration of an Edmonston strain MV genetically engineered to produce NIS (MV-NIS), in combination with the PD-L1 inhibitor atezolizumab
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
28 days after MV-NIS administration for each dose cohort
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
MV-NIS and Atezolizumab
MV-NIS will be administered intratumorally as a single dose on day 1. Atezolizumab 1200 mg IV will be given at day 15 and then every 3 weeks.
MV-NIS: This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
Atezolizumab: Atezolizumab will be administered every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
MV-NIS and Atezolizumab
MV-NIS will be administered intratumorally as a single dose on day 1. Atezolizumab 1200 mg IV will be given at day 15 and then every 3 weeks.
MV-NIS: This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
Atezolizumab: Atezolizumab will be administered every 3 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Investigator decision
|
1
|
Baseline Characteristics
Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab
Baseline characteristics by cohort
| Measure |
MV-NIS and Atezolizumab
n=2 Participants
MV-NIS will be administered intratumorally as a single dose on day 1. Atezolizumab will be given at day 15 and then every 3 weeks.
MV-NIS: This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
Atezolizumab: Atezolizumab will be administered every 3 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after MV-NIS administration for each dose cohortPopulation: The study was prematurely closed for administrative reasons. The very limited number of patients (n=2) and short duration of study treatment does not allow any meaningful conclusions to be drawn from the available data.
To determine the maximum tolerated dose (MTD) of the intra-tumoral administration of an Edmonston strain MV genetically engineered to produce NIS (MV-NIS), in combination with the PD-L1 inhibitor atezolizumab
Outcome measures
Outcome data not reported
Adverse Events
MV-NIS and Atezolizumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MV-NIS and Atezolizumab
n=2 participants at risk
MV-NIS will be administered intratumorally as a single dose on day 1. Atezolizumab will be given at day 15 and then every 3 weeks.
MV-NIS: This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
Atezolizumab: Atezolizumab will be administered every 3 weeks
|
|---|---|
|
Infections and infestations
Chills
|
100.0%
2/2 • Number of events 2 • AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.
|
|
Infections and infestations
Viral illness
|
100.0%
2/2 • Number of events 2 • AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
2/2 • Number of events 3 • AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.
|
|
Gastrointestinal disorders
Nausa
|
50.0%
1/2 • Number of events 1 • AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place