About this trial
This is a single center, phase Ib/II study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will augment the clinical activity of those two drugs.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC.
Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the PD-L1 testing are not required for enrollment.
Measurable disease per RECIST 1.1.
At least 18 years of age.
Disqualifiers
Mixed histology including small cell lung cancer.
classic EGFR mutations
HER2 mutation
ALK fusion
Trial design
Treatments tested in this trial
- Ipilimumab
- Nivolumab
- Nogapendekin alfa inbakicept
Treatment groups
Sponsors and collaborators
Washington University School of Medicine
Lead sponsor
ImmunityBio, Inc.
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator