BMS-813160 + Nivolumab + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byKian-Huat Lim, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new combination of four drugs to treat pancreatic cancer. It aims to see if combining immune-boosting and cancer-killing drugs can improve treatment outcomes.

Eligibility Criteria

Adults with locally advanced or borderline resectable pancreatic ductal adenocarcinoma, who haven't had prior chemotherapy or radiation for this disease. They must have good organ function and blood counts, not be on immunosuppressants, agree to use two forms of contraception if applicable, and sign a consent form. Exclusions include those with certain heart diseases, recent major surgeries, active infections requiring therapy, known HIV or hepatitis B/C infection.

Inclusion Criteria

My bone marrow and organs are functioning normally.

I am 18 years old or older.

I am fully active and can carry on all my pre-disease activities without restriction.

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Exclusion Criteria

I have no stomach or intestine problems affecting my medication absorption.

I do not have any uncontrolled illnesses or infections needing treatment within the last week.

I have had an organ or stem cell transplant from a donor.

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Treatment Details

Interventions

Biopsy (Other)
BMS-813160 (Other)
Gemcitabine (Chemotherapy)
Nab-paclitaxel (Chemotherapy)
Nivolumab (Monoclonal Antibodies)
Peripheral blood (Other)

Trial OverviewThe trial is testing a new drug combination for treating pancreatic cancer: BMS-813160 with nivolumab (an immune system booster), gemcitabine and nab-paclitaxel (chemotherapy drugs). The study aims to evaluate the side effects and how well the disease responds to this treatment regimen.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Part B - Dose expansionExperimental Treatment6 Interventions

* BMS-813160 300 mg twice per day * Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle * Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle * Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle * Post-treatment biopsy at the end of cycle 2 * Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles

Group II: Part A - Experimental Dose Level 0Experimental Treatment6 Interventions

* BMS-813160 300 mg twice per day * Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle * Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle * Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle * Post-treatment biopsy at the end of cycle 2 * Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cyclesore cycles

Group III: Part A - Control (chemotherapy only)Active Control4 Interventions

* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle * Post treatment biopsy at the end of cycle 2 * Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles