Nivolumab With Ipilimumab Combined With TGFβ-15 Peptide Vaccine and Radiotherapy for Pancreatic Cancer
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
"Non-immunogenicity" of PC with high prevalence of immunosuppressive cells and typically a
scarcity of tumor-infiltrating effector lymphocytes is considered as one of the reasons for
lacking responsiveness to single-agent immunotherapies. Considering the emerging role of the
tumor microenvironment, the combination of checkpoint blocking antibodies with
immunomodulation of the tumor microenvironment could lead to better responses in tumor
historically resistant to radiation and checkpoint blocking antibody approaches as single
modalities. For example, the data from the phase 2 study CheckPAC (NCT02866383) showed
durable clinical benefit in a small subgroup of patients after adding SBRT of 15 Gy to a
combination of nivolumab and ipilimumab (presented at ASCO GI 2022, San Fransisco) in
patients with resistant metastatic PC. Furthermore, we have found that the TGFβ-15 immune
response is corelated to clinical benefit, supporting the rationale for combining of TGFβ-15
peptide vaccine with CheckPAC strategy (SBRT of 15 in combination with nivolumab and
ipilimumab).