NALIRIFOX + GnP for Pancreatic Cancer

Overseen By Lalta Dhanantwari, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwell Health

Disqualifiers: CNS metastases, Cardiac disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating metastatic pancreatic cancer, which has spread from the pancreas to other parts of the body. The trial alternates between two chemotherapy regimens, NALIRIFOX and GnP (Gemcitabine plus nab-Paclitaxel), to determine if this combination is more effective than past treatments. It is open to individuals diagnosed with certain types of pancreatic cancer that have spread and have not received chemotherapy for the metastatic disease. Participants should have a noticeable tumor on scans that can be measured to track changes during treatment.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments NALIRIFOX and Gemcitabine plus nab-Paclitaxel (GnP) are safe for people with pancreatic cancer.

Studies have found NALIRIFOX to be generally safe, with most individuals tolerating it without serious side effects. Some may need dose adjustments to minimize side effects, but this does not reduce the treatment's effectiveness.

Similarly, research indicates that Gemcitabine plus nab-Paclitaxel is generally safe. Patients typically experience mild to moderate side effects and tolerate the combination well. This treatment has been used for some time and has been shown to extend the lives of people with pancreatic cancer.

Overall, both treatments have demonstrated safety, with necessary adjustments made to manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for pancreatic cancer, which often involve traditional chemotherapy protocols, NALIRIFOX combines liposomal irinotecan, oxaliplatin, and fluorouracil (5-FU) in a novel regimen. This combination is designed to enhance the delivery and effectiveness of the drugs, potentially improving outcomes for patients. Gemcitabine plus nab-Paclitaxel (GnP), another treatment in the trial, is already known for its effectiveness but is administered in a slightly different schedule that might offer benefits in patient response and tolerability. Researchers are excited because these innovative approaches may lead to more effective and faster-acting therapies for a condition that is notoriously difficult to treat.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

This trial will compare the effectiveness of two treatments for pancreatic cancer: NALIRIFOX and Gemcitabine plus nab-Paclitaxel (GnP). Research has shown that the NALIRIFOX treatment could be promising for pancreatic cancer. In past studies, patients experienced an average of 3.7 months before cancer progression and lived an average of 7.7 months overall. This treatment might be safe and could extend patients' lives.

Conversely, studies have found that combining gemcitabine and nab-paclitaxel can extend the lives of patients with advanced pancreatic cancer. Patients using this combination have experienced a noticeable increase in both the time before cancer worsens and overall survival. The best response rate was 58%, with an average overall survival of 24.7 months. Both treatments in this trial have demonstrated effectiveness and potential benefits for patients with this type of cancer. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with metastatic pancreatic cancer, measurable lesions, and acceptable organ function can join. They must not have had chemotherapy for metastatic disease or certain genetic mutations (BRCA1/2, PALB2). Pregnant women and those with a short life expectancy or severe health issues are excluded.

Inclusion Criteria

Radiographic evidence of metastatic disease

At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Laboratory assessments within 14 days meeting specified criteria

Exclusion Criteria

Life expectancy < 12 weeks

Pregnant or breastfeeding women

Medical or social conditions likely to interfere with study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly alternating chemotherapy regimens of NALIRIFOX and GnP

6 months

Visits on Days 1, 8, and 15 of each month

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine plus nab-Paclitaxel
• NALIRIFOX

Trial Overview The trial is testing the effectiveness of alternating two chemotherapy regimens monthly: NALIRIFOX and GnP (Gemcitabine plus nab-Paclitaxel), against previous outcomes in patients with advanced pancreatic cancer.

How Is the Trial Designed?

Group I: NALIRIFOX Active Control 1 Intervention

NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15

Group II: Gemcitabine plus nab-Paclitaxel (GnP) Active Control 1 Intervention

GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1304369

Increased Survival in Pancreatic Cancer with nab ... In patients with metastatic pancreatic adenocarcinoma, nab-paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and ...

2. nature.com nature.com/articles/s41598-025-96157-6

Efficacy of gemcitabine plus nab-paclitaxel in second-line ... This study demonstrates the contribution of gemcitabine plus nab-paclitaxel in both OS and PFS in second-line treatment of metastatic pancreatic cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6254624/

Efficacy of Nab-Paclitaxel Plus Gemcitabine and ... The primary outcome measures were OS and progression-free survival (PFS). OS was determined from the date of first chemotherapy to death from any cause, whereas ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1424390324000772

Treatment outcomes of gemcitabine plus nab-paclitaxel in ... Gemcitabine plus nab-paclitaxel (GnP) therapy has been shown to improve the prognosis in patients with metastatic pancreatic cancer (PC); however, ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2018.36.4_suppl.407

Clinical outcomes of gemcitabine plus nab-paclitaxel (GnP) ... Best objective response rate was 58% and median time to partial response was 60 days (40-212). Median overall survival (mOS) was 24.7 months (95 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38599956/

Treatment outcomes of gemcitabine plus nab-paclitaxel in ... Conclusion: GnP showed moderate efficacy with manageable safety profile in PC patients with MA. However, PC patients with moderate to massive ascites still have ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00746

Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study TTFields therapy with gemcitabine ± nab-paclitaxel was feasible, safe, and active in patients with advanced pancreatic adenocarcinoma in the ...