Phase II, open label, randomized multicenter study to evaluate efficacy and safety of study treatment in previously untreated patients with advanced pancreatic cancer. Patients will receive study treatment for a maximum of 24 months or until progression disease or until unacceptable toxicity. In the experimental arm, patients who discontinue chemotherapy for reasons other than disease progression may continue receiving the remaining study drugs (NLM-001, botensilimab and balstilimab) up to a maximum of 24 months, according to schedule.
Investigators must ensure that patients are able to understand the requirements of the study and provide informed consent.
Age ≥18 years.
Histological or cytological diagnosis of pancreatic adenocarcinoma.
Stage IV disease.
Active or uncontrolled infectious disease or serious medical condition that may interfere with the patient's eligibility or treatment.
History of psychiatric condition that would compromise the patient's ability to understand or comply with the requirements of the protocol, or the ability to provide informed consent.
Concurrent antineoplastic therapy.
Prior chemotherapy or chemo-radiation therapy for advanced pancreatic cancer.