Trials / Completed
CompletedNCT03496662
BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase I/II Study to Evaluate the Tolerability and Efficacy of BMS-813160 (CCR2/5 Inhibitor) With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-813160 | BMS-813160 will be supplied by Bristol Myers Squibb |
| DRUG | Nivolumab | Nivolumab will be supplied by Bristol Myers Squibb |
| DRUG | Gemcitabine | Gemcitabine will be given as per routine care from commercial supply. |
| DRUG | Nab-paclitaxel | Nab-paclitaxel will be given as per routine care from commercial supply. |
| PROCEDURE | Biopsy | Pre-treatment, end of cycle 2, end of treatment for patients who progress or otherwise do not go to surgery, and surgery for patients who do go to surgery |
| PROCEDURE | Peripheral blood | -Cycle 1 Day 1 before treatment begins, after 2 cycles of treatment +/- 3 days of mandatory tumor biopsy, end of treatment for patients who progress or otherwise do not go to surgery, and no more than 24 hours prior to time of surgery (if applicable) |
Timeline
- Start date
- 2018-08-31
- Primary completion
- 2021-10-28
- Completion
- 2024-07-25
- First posted
- 2018-04-12
- Last updated
- 2025-07-29
- Results posted
- 2022-11-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03496662. Inclusion in this directory is not an endorsement.