A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Prior treatment with PRMT5 and MAT2A inhibitors.
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to trial enrolment is not permitted.
Participants with other primary cancers are excluded, except for adequately treated nonmelanoma skin cancer, prostate cancer post-resection with undetectable PSA, in-situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or solid tumors (including lymphomas without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study entry.
Major surgery within 2 weeks of starting treatment is not permitted. Participants must have recovered from the effects of any major surgery.
Trial design
Treatments tested in this trial
- BMS-986504
- Gemcitabine
- Nab-paclitaxel
- mFOLFIRINOX
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov