Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC
Status:
Active, not recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy
of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC.
Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA
Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab]
The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded
to 20 subjects (inclusive of subjects from the run-in).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborators:
Boehringer Ingelheim Cancer Research Institute, New York City CureVac AG MedImmune LLC PharmaJet, Inc.