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A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer

ConditionsPhase 2 StudyBMS-986504MTAP-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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BMS-986504

    Drug

    Given by po

  • Gemcitabine

    Drug

    Given by IV

  • Nab-paclitaxel

    Drug

    Given by IV

  • mFOLFIRINOX

    Drug

    Given by iv

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 3 interventions
Group B: Cohort 2Experimental treatment 3 interventions
Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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