Untreated Metastatic Pancreatic Ductal Adenocarcinoma Advanced pancreatic cancer
Conditions
Interventions
Sponsors
Bristol-Myers Squibb Company
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for clinical performance study: Patients with PDAC that harbour homozygous MTAP deletions, for whom biomarkers are detected by F1CDx are included in this CPS. Alternatively, participants can be enrolled to the CA2400030 study based on other Sponsor-provided central tests or an available, sponsor pre-approved, local NGS result. Tumor tissue samples from these participants will be retrospectively tested with F1CDx and the results will be used for clinical bridging. Refer to Section 6.1 of the CA2400030 study protocol for additional inclusion criteria for subjects participating in the CA2400030 study. One FFPE tumour specimen per patient will be needed for each F1CDx test. Each sample must include 10 unstained FFPE slides and 1 hematoxylin and eosin (H&E) slide for pathology review OR 11 unstained slides to allow for the use of one slide for H&E staining.
Exclusion criteria
Exclusion criteria: Exclusion criteria for clinical performance study: Patients without homozygous MTAP deletions as detected by the enrolment assays in the CA2400030 study. Refer to Sections 6.2 of the CA2400030 study protocol for exclusion criteria for subjects participating in the CA2400030 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint that will be used in the CPS to establish the clinical performance of F1CDx as a CDx for BMS-986504 in combination with nab-paclitaxel and gemcitabine in PDAC patients with homozygous MTAP deletion will be progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumours Guideline (RECIST v1.1) per investigator assessment, defined as the time between the randomization date and the date of disease progression or death from any cause (whichever occurs first). In addition, overall survival (OS), defined as the time from the randomization date to the date of death from any cause, is evaluated as a dual primary endpoint with PFS for phase 3. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Turkey
Contacts
Public ContactS Bollinger
Bristol-Myers Squibb Company
Outcome results
None listed