Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The primary objective is to assess tolerability and safety of a personalized neo-antigen
vaccine containing up to 15 peptides derived from somatic mutation of the individual
patient's cancer, with CAF09b as adjuvant. The vaccine formulation will be administered in
combination with an approved anti-PD-1 or anti-PD-L1 inhibitor to patients with advanced
solid tumors. The endpoint is the characterization of adverse events (AE) assessed by CTCAE
4.0.
The secondary objective is feasibility to manufacture a personalized neo-antigen vaccine
within 6 weeks of enrolment with the PIONEER pipeline, and to evaluate the immune response
before, during and after treatment with the personalized neo-antigen vaccine. And evaluate
the effect on the immune response correlated to dose escalation of peptides in the vaccine.
The endpoint is to evaluate the induction of adaptive immune responses to the personalized
neo-antigen vaccine measured by functional assays and peptide-MHC multimer stainings.
The tertiary objective is to evaluate the clinical efficacy of the treatment. The endpoints
will be objective responses (OR), progression free survival (PFS) and overall survival (OS).