A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer… (NCT07578337) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.
Spain40 participantsStarted 2026-07-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. No prior treatment for advanced disease. Patients who have received chemotherapy for localized disease are eligible if they progress within six months from the last chemotherapy treatment.
. Measurable disease per iRECIST 1.1 as determined by the investigator.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. Sufficient hematopoietic, renal and liver function as defined as:
Exclusion criteria
. 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.
. Prior anti-PD-(L)1 or anti-CTLA-4 as prior therapy(ies).
. Pregnant or lactating women.
. History of allergic reactions attributed to compounds of similar chemical structure or similar biological study drug composition.
. History of life-threatening serious adverse events to Gemcitabine or Nab-Paclitaxel.