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Protocol NumberCA2400030
Active

2025-07-15 - 2029-11-13

Phase II/III

Recruiting4

ICD-10C25.0

Malignant neoplasm of head of pancreas

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9157.0

Malignant neoplasm of head of pancreas

A randomized, phase 2/3 trial was conducted in treatment-naïve patients with homologous MTAP deficiency in metastatic pancreatic ductal adenocarcinoma. The efficacy of BMS-986504 combined with Nab-paclitaxel and Gemcitabine was compared with placebo combined with Nab-paclitaxel and Gemcitabine.

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/23

Investigators and Locations

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 姜乃榕 Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Chi Chou
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic pancreatic duct adenocarcinoma

Objectives

The study evaluated the disease progression-free survival (PFS) of BMS-986504 plus nab-p/gem compared to placebo plus nab-p/gem in treatment-naïve participants with homologous MTAP deletion.

Test Drug

BMS-986504

Active Ingredient

BMS-986504

Dosage Form

Tablets

Dosage

200 mg

Endpoints

PFS, as assessed by the trial administrator according to RECIST v1.1, is defined as the time from randomization to disease progression (PD) or death from any cause (whichever occurs first).

Inclution Criteria

● Metastatic PDAC confirmed by histological or cytological methods.

● Evidence of homologous MTAP loss or depletion detected in tumor tissue.

● At least one metastatic lesion measurable according to RECIST v1.1.

● Subjects must not have received any systemic anticancer therapy in metastatic cases.

● Subjects may receive up to one cycle of nab-p/gem in metastatic cases if clinically necessary and at the discretion of the trial administrator, provided their disease has not progressed or treatment has been discontinued due to intolerable toxicity.

● The initial nab-p/gem cycle in metastatic cases must be completed before randomization, and the last dose of this cycle must be administered 14 days prior to randomization.

Exclusion Criteria

● (Present during the screening period) a concurrent malignant tumor requiring treatment, or a history of malignant tumor within 2 years prior to screening.

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    470 participants

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