Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
The objective of the proposed clinical trial is to investigate the safety and tolerability of
CV301 in combination with Anti-PD1-Therapy in subjects with non-small cell lung cancer
(NSCLC).
The clinical trial is designed to evaluate the possible enhanced antitumor activity of CV301
with Anti-PD1-Therapy. The rationale for combining CV301 with Anti-PD1-Therapy is based on
the hypothesis that CV301 can induce specific immune response in the tumor, and that in
combination, Anti-PD1-Therapy may augment the T cell-mediated immune response generated by
CV301 by blocking the inhibitory signal of the PD-1.
The trial will include a Phase 1 portion and a Phase 1b portion with 2 cohorts. The Phase 1
portion is a dose escalation part to assess the safety and tolerability of CV301 alone, prior
to moving into the combination with Anti-PD1-Therapy (the Phase 1b component).
The following Phase 1b portion of the trial aims to test the safety and tolerability of the
combination treatment using a two cohort approach with cohort 1 receiving CV301 plus
Nivolumab and cohort 2 receiving CV301 plus Pembrolizumab.
n/a
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