ctDNA Assay for Pancreatic Cancer

Overseen By Gretel Terrero, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

Must be taking: Folfirinox

Disqualifiers: Neuroendocrine neoplasms, Brain metastases, 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: Unknown

Duration: 8 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a blood test called ctDNA to determine if it can quickly indicate treatment effectiveness for individuals with advanced pancreatic cancer. The goal is to assess whether ctDNA can help doctors make faster treatment decisions instead of waiting for standard imaging scans. Participants will receive various chemotherapy drugs, including 5-Fluorouracil, Gemcitabine, Irinotecan, Leucovorin, Nab Paclitaxel, and Oxaliplatin, and the trial will monitor the effectiveness of these treatments. Individuals diagnosed with advanced pancreatic cancer and having a tumor measurable on a scan might be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

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

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

Research on the safety of treatments in this study has revealed important findings for both mFOLFIRINOX and the combination of gemcitabine with nab-paclitaxel.

Studies have shown that mFOLFIRINOX, a mix of four chemotherapy drugs, is commonly used to treat pancreatic cancer. Research indicates that patients receiving mFOLFIRINOX often respond better to treatment compared to some other options. However, patients might experience side effects, including low blood cell counts and digestive issues.

Similarly, the combination of gemcitabine and nab-paclitaxel is a well-established treatment for pancreatic cancer. Research indicates that this combination can help patients live longer. Still, patients may experience side effects like tiredness, low blood counts, and nerve damage.

Both treatments are commonly used in practice, demonstrating general safety. However, each person's experience can vary, so discussions with a healthcare provider can help clarify personal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ctDNA monitoring for pancreatic cancer because it adds a new layer of personalization to treatment. Unlike traditional chemotherapy, which is given on a set schedule regardless of individual response, ctDNA monitoring allows doctors to tailor the chemotherapy regimen based on real-time changes in tumor DNA in the blood. This means treatment can be adjusted more quickly if the current approach isn’t working, potentially improving patient outcomes. By detecting changes in tumor DNA early, this method could help in switching treatments sooner, possibly enhancing effectiveness and reducing unnecessary side effects.

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

Research has shown that the combination of Gemcitabine and Nab-Paclitaxel, which participants in this trial may receive, effectively treats pancreatic cancer. Studies have found that this combination extends patient survival and slows disease progression, with manageable side effects. Another treatment option in this trial is mFOLFIRINOX, which includes four drugs: 5-Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin. mFOLFIRINOX also improves survival and controls the disease better than some other treatments. Patients using mFOLFIRINOX responded well and experienced longer periods without cancer worsening. Both treatments have strong evidence supporting their effectiveness in managing pancreatic cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Gretel Terrero, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic pancreatic ductal adenocarcinoma. Participants should be starting first-line mFOLFIRINOX chemotherapy. The study aims to include those who haven't yet had imaging scans post-chemotherapy initiation.

Inclusion Criteria

Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.

Adequate biological parameters as demonstrated by specified blood counts and blood chemistry levels.

My pancreatic cancer is confirmed and has spread, but it's not purely neuroendocrine.

Exclusion Criteria

My ability to care for myself has worsened since my last doctor's visit.

Pregnant or nursing.

I do not have any major heart problems or irregular heart rhythms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ctDNA monitoring in combination with standard of care chemotherapy (mFOLFIRINOX) for up to 8 months

8 months

Regular visits for ctDNA monitoring and chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to receive treatment based on ctDNA results and radiographic response

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• 5-Fluorouracil
• Gemcitabine
• Irinotecan
• Leucovorin
• Nab Paclitaxel
• Oxaliplatin

Trial Overview The study tests if a blood test (ctDNA assay) can quickly show how well the tumor responds to mFOLFIRINOX chemo, compared to waiting for the first imaging scans at 8 weeks. It may lead to faster treatment adjustments.

How Is the Trial Designed?

Group I: Part 2 Arm B: Early Switch of Chemotherapy Interventional Cohort Experimental Treatment 7 Interventions

Participants in this group will receive ctDNA monitoring in combination with standard of care Gemcitabine and Nab-Paclitaxel therapy, after completion of up to three cycles of mFOLFIRINOX from Part 2 Arm A. Participants will receive standard of care treatment for up to 8 months. Total participation duration is approximately 18 months.

Group II: Part 1: Early Switch of Chemotherapy Interventional Cohort Experimental Treatment 5 Interventions

Participants in this group will receive ctDNA monitoring in combination with standard of care (SOC) of 5-fluorouracil, leucovorin, irinotecan, oxaliplatin (mFOLFIRINOX). Participants will receive standard of care treatment for up to 8 months. Total participation duration is approximately 18 months.

Group III: Part 2 Arm A: Early Switch of Chemotherapy Interventional Cohort Active Control 5 Interventions

Participants in this group will receive ctDNA monitoring in combination with standard of care (SOC) of 5-fluorouracil, leucovorin, irinotecan, oxaliplatin (mFOLFIRINOX). After completing three cycles of therapy, participants with methylated-ctDNA fold change of less than threshold determined in Part 1 will continue to receive additional cycles of mFOLFIRINOX for up to 8 months. Participants with methylated-ctDNA fold-change of greater than threshold determined in Part 1 may switch to Part 2 Arm B. Total participation duration is approximately 18 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

BillionToOne, Inc

Collaborator

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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 ... Our findings revealed a PFS of 5.1 months and an OS of 8.6 months. The majority of observed adverse effects were manageable.

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. apc.amegroups.org apc.amegroups.org/article/view/8541/html

Efficacy and toxicity of gemcitabine plus nab-paclitaxel in ... Results: The study population consists of 29 patients. The overall response rate (ORR) was 17.2% and the disease control rate (DCR) was 48.3%.

5. 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 demonstrated to be effective for improving the survival prognosis in patients with metastatic PC, and is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8953820/

A Review on the Efficacy and Safety of Nab-Paclitaxel ... Pancreatic cancer has one of the highest mortality rates among cancers, and a combination of nab-paclitaxel with gemcitabine remains the cornerstone of first- ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/1120009X.2023.2190712

Clinical outcome and safety profile of metastatic pancreatic ... It has been reported that the five-year survival rate is less than 8% for metastatic pancreatic cancer (mPC) [Citation4]. The optimal regimen is not well ...