BMS-986340 Combination for Pancreatic Cancer

Not yet recruiting at 2 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Pregnancy, HIV, Autoimmune diseases, 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: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment for individuals with pancreatic cancer that has spread or recurred after remission. It combines a new monoclonal antibody, BMS-986340, with other treatments to determine if they can safely and effectively slow or halt cancer growth. This trial may suit those diagnosed with metastatic or recurrent pancreatic cancer seeking new treatment options. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing access to promising new therapies.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

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

A study found that BMS-986340, whether used alone or with nivolumab, demonstrated a promising safety profile in patients with various cancer types. This suggests it might be well-tolerated in other situations as well. Research has shown that nab-paclitaxel can improve survival rates in pancreatic cancer, though it may cause some side effects. Additionally, nivolumab has been tested with other treatments for pancreatic cancer and was found to be tolerable. Given the phase of this trial, the treatment is expected to be safe, but researchers are closely monitoring it for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination treatment involving BMS-986340 for pancreatic cancer because it introduces a novel component to the existing treatment regimens. Unlike the standard of care, which typically includes chemotherapy agents like nab-paclitaxel and gemcitabine, this treatment adds BMS-986340, an experimental drug that targets cancer cells differently. This approach aims to enhance the immune response against the cancer by incorporating nivolumab, an immunotherapy drug, alongside the chemotherapy. The hope is that this combination will improve effectiveness and offer a new avenue for tackling pancreatic cancer, which is notoriously difficult to treat.

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

In this trial, participants will receive a combination of treatments: BMS-986340, nivolumab, gemcitabine, and nab-paclitaxel. Studies have shown that gemcitabine and nab-paclitaxel together effectively and safely treat advanced pancreatic cancer by stopping cancer cells from growing and spreading. Nivolumab, an immunotherapy drug, may help the immune system attack and slow down the cancer. BMS-986340, a monoclonal antibody, may target specific parts of cancer cells to halt their growth. Together, these treatments could effectively address pancreatic cancer that has spread or recurred. Early research suggests this approach may be safe and manageable for patients. ^{1 5 6 7 8}

Who Is on the Research Team?

Tanios S. Bekaii-Saab, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with pancreatic adenocarcinoma that has spread or returned after treatment. Specific eligibility criteria are not provided, but typically include factors like age, health status, and cancer stage.

Inclusion Criteria

Willing to return to enrolling institution for follow-up

I am 18 years old or older.

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

Exclusion Criteria

Pregnant persons

Nursing persons

Participants of childbearing potential unwilling to employ adequate contraception

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab, BMS-986340, nab-paclitaxel, and gemcitabine in 28-day cycles for up to 2 years

Up to 2 years

Visits on days 1 and 15 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986340
• Nab-paclitaxel
• Nivolumab

Trial Overview The trial tests BMS-986340 combined with nivolumab (an immunotherapy), gemcitabine (a chemotherapy drug), and nab-paclitaxel (a formulation of a chemo drug) to see safety, side effects, best dose, and effectiveness against metastatic or recurrent pancreatic cancer.

How Is the Trial Designed?

Group I: Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel) Experimental Treatment 8 Interventions

Patients receive nivolumab IV over 30 minutes and BMS-986340 IV over 60 minutes on day 1, as well as nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, tissue biopsy, and CT throughout the study. Additionally, patients with known or suspected brain metastases may also undergo brain MRI throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226856?cond=cancer

BMS-986340 in Combination With Nivolumab ... Giving BMS-986340 in combination with nivolumab, gemcitabine, and nab-paclitaxel may be safe, tolerable, and/or effective in treating patients with metastatic ...

2. trial.medpath.com trial.medpath.com/clinical-trial/3df3a1b5c27a310f/nct07226856-bms-986340-nivolumab-gemcitabine-nab-paclitaxel-pancreatic-adenocarcinoma

BMS-986340 in Combination With Nivolumab, Gemcitabine ... Giving BMS-986340 in combination with nivolumab, gemcitabine, and nab-paclitaxel may be safe, tolerable, and/or effective in treating patients with metastatic ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32554514/

Open-label, Phase I Study of Nivolumab Combined with ... The safety profile of nivolumab plus nab-paclitaxel and gemcitabine at standard doses in advanced pancreatic cancer was manageable, with no unexpected safety ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40125795/

Neoadjuvant BMS-813160, nivolumab, gemcitabine and ... Conclusions: Neoadjuvant BMS-813160/nivolumab/GnP was well tolerated and appears to achieve comparable ORR and resectability to historical data, ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-018-5244-2

Real world evidence on gemcitabine and nab-paclitaxel ... This study confirms the effectiveness and safety of first-line Gem/NabP in both locally advanced and metastatic PDA in a real world setting.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04895709

NCT04895709 | A Study of BMS-986340 as Monotherapy ... The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or ...

7. bcan.org bcan.org/clinicaltrials/bms-986340-as-monotherapy-and-in-combination-with-nivolumab-or-docetaxel-in-participants-with-advanced-solid-tumors/

BMS-986340 as Monotherapy and in Combination With ... The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or ...

8. clinicaltrials.eu clinicaltrials.eu/inn/bms-986340/

Bms-986340 – Application in Therapy and Current Clinical ... The study aims to assess the safety, tolerability, and recommended dosage of BMS-986340 in patients with different types of cancer, including lung, gastric, ...