A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
M.D. Anderson Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Age ≥18 years. * Homozygous MTAP deletion detected by NGS. Test can be performed on an archival tissue collected within 6 months from study enrollment and on blood samples. * ECOG performance status 0-1. * Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) * Adequate organ and marrow function as defined below * Hemoglobin ≥9.0 g/dL with no packed red blood cell transfusions in the past 7 days. * Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L. * Platelet count ≥100 x 10⁹/L with no platelet transfusions in the past 7 days. * Total bil…
Interventions
- DrugBMS-986504
Given by po
- DrugGemcitabine
Given by IV
- DrugNab-paclitaxel
Given by IV
- DrugmFOLFIRINOX
Given by iv
Location
- MD Anderson Cancer CenterHouston, Texas