Recurrent Non-Small Cell Lung Cancer
Conditions
Keywords
Lung Cancer Measles Nivolumab Opdivo
Brief summary
This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and metastatic NSCLC.
Detailed description
Phase 1, dose escalation study of the combination of intra-tumoral MV-NIS and systemic atezolizumab in patients with recurrent and metastatic NSCLC. After the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the MTD. A standard 3+3 design was to be used for the dose escalation part of the study. Starting at dose level 1, three patients were to be treated per dose level. MV-NIS was to be administered once intra-tumorally (IT) on Day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8
Interventions
BIOLOGICALMV-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
BIOLOGICALAtezolizumab
Atezolizumab will be administered every 3 weeks
Sponsors
Vyriad, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS. * Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. * Ability to provide informed consent. * Adequate hematological, liver and kidney function. * Must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration. Key
Exclusion criteria
* Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration * Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation). * Pregnant women. * Nursing women. * Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment. * Allergy to measles vaccine or history of severe reaction to prior measles vaccination. * History of organ transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab | 28 days after MV-NIS administration for each dose cohort | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MV-NIS and Atezolizumab 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 | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Investigator decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | MV-NIS and Atezolizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
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
Time frame: 28 days after MV-NIS administration for each dose cohort
Population: 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.