Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Locally Advanced Pancreatic Cancer.
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
Pancreatic ductal adenocarcinoma (PDAC) remains a dreadful disease due to its often advanced
stage at diagnosis and poor sensitivity to chemotherapy. A locally unresectable tumor
(locally advanced pancreatic cancer (LAPC)) is present in 30% of the cases and is defined as
a surgically unresectable tumor encasing the adjacent arteries [celiac axis, superior
mesenteric artery (SMA)]. In these patients, chemotherapy has been the standard treatment for
decades, optionally combined with radiotherapy. The results of small randomized trials
comparing chemoradiotherapy with chemotherapy of patients with LAPC are divergent.
Considering the emerging role of the tumor microenvironment (TME), the combination of
checkpoint blocking antibodies with agents that target the inhibitory effects of the TME
could lead to better responses in tumor historically resistant to checkpoint blocking
antibody approaches. Furthermore, the addition of standard-of-care chemotherapy could further
potentiate the anti-tumor effects of immunotherapy approaches by reducing the tumor burden,
exposing antigens, and directly affecting the immunosuppressive TME compartment.
To explore the safety and synergy of the proposed combinatorial approach, participants with
locally advanced PC will receive nivolumab and ipilimumab administered in combination with
gemcitabine and nab-paclitaxel followed by immune-chemoradiation.