Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT07283705
Brief 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
Study:
NCT07283705
Study Brief:
Protocol Section:
NCT07283705