Trials / Recruiting
RecruitingNCT07283705
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To find out if the combination of BMS-986504 plus neoadjuvant/adjuvant chemotherapy and surgery (Cohort 1) or BMS-986504 plus standard of care chemotherapy (Cohorts 2 and 3) can help to control pancreatic cancer.
Detailed description
Primary Objectives * Cohort 1: To evaluate the safety and tolerability of BMS-986504 in combination with neoadjuvant/adjuvant chemotherapy and as maintenance therapy in participants with resectable/borderline resectable PDAC. Major pathological response (MPR) and incidence, severity and duration of pre- and post-operative complications (e.g. delay of surgery, inability to get surgery, type and rate of postoperative complications \[like pancreatic fistula\], rate of resection for borderline participants) will be evaluated. * Cohorts 2 and 3: To evaluate the safety, tolerability and efficacy of BMS-986504 in concomitant with SOC chemo and as maintenance therapy. Efficacy will be evaluated as disease control (PFS) at 6 months in participants with locally advanced (Cohort 2) and metastatic (Cohort 3) PDAC. Secondary Objectives • To evaluate 6-month overall response rate (ORR) and disease control rate (DCR) for Cohorts 1,2 and 3
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986504 | Given by po |
| DRUG | Gemcitabine | Given by IV |
| DRUG | Nab-paclitaxel | Given by IV |
| DRUG | mFOLFIRINOX | Given by iv |
Timeline
- Start date
- 2026-05-18
- Primary completion
- 2029-10-01
- Completion
- 2031-10-01
- First posted
- 2025-12-16
- Last updated
- 2026-04-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07283705. Inclusion in this directory is not an endorsement.