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.
Parallel
Gemcitabine (1000 mg/m2)
DrugGemcitabine 1,000 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
Nab-paclitaxel (Abraxane)
DrugNab-P 125 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
NLM-001
DrugNLM-001: 800 mg/day, p.o, once daily (4 tablets of 200 mg) days -4 to -1 and 10-13 of each cycle.
Botensilimab
DrugBotensilimab: 75 mg every 6 weeks for 4 administrations, from D1C1.
Balstililmab
DrugBalstilimab: 240 mg IV Day 1 and Day 15 of each 28-day cycle.
To evaluate the response rate in each of the study arms, assessed according to iRECIST criteria, including the confirmation of progression to distinguish true progression from potential pseudoprogression.
Objective Response Rate (ORR): Complete Response (CR) + Partial Response (PR), according to iRECIST 1.1 criteria, according to investigator criteria. Suspected progression (including possible pseudoprogression due to immune-related effects or new lesions) must be confirmed with repeat imaging performed 4-8 weeks after the initial assessment before considering the patient as having true disease progression.
To evaluate safety profile and tolerability of study treatment according to NCI-CTCAE v 5.0 criteria.
Safety profile will be assessed according to NCI-CTCAE v 5.0 criteria. The number of patients experiencing each AE will be summarized by CTCAE grade.
To evaluate treatment efficacy according to progression free survival (PFS)
Progression Free Survival (PFS): PFS is defined as the time in months from the patient's randomization until patient progression according to iRECIST 1.1 criteria or death.
To evaluate treatment efficacy according to 6 months PFS
Progression Free Survival (PFS): PFS is defined as the time in months from the patient's randomization until patient progression according to iRECIST 1.1 criteria or death.
To evaluate treatment efficacy according todisease control rate (DCR)
Disease Control Rate (DCR): Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated by iRECIST 1.1 criteria according to investigator criteria.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
