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Trial ID CA240-0030  |   NCT07076121

A Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)

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Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 143
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
    1. Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue.
      1. Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1).
        1. Participants must not have received any systemic anticancer treatments in the metastatic setting.
          1. If clinically indicated and as per investigator discretion, participants may receive up to 1 cycle of Nab-paclitaxel/Gemcitabine (nab-p/gem) in the metastatic setting and must have not progressed or required discontinuation due to intolerable toxicity.
            1. Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization.

              Exclusion Criteria

              Exclusion Criteria Icon
              :
              • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Arm A

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986504, Gemcitabine, Nab-paclitaxel

                  Study Arms

                  Experimental: Arm B

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986504, Gemcitabine, Nab-paclitaxel

                  Study Arms

                  Placebo Comparator: Arm C

                  ASSIGNED INTERVENTION
                  • Drug: Gemcitabine, Nab-paclitaxel, Placebo

                  Study Arms

                  Placebo Comparator: Arm D

                  ASSIGNED INTERVENTION
                  • Drug: Gemcitabine, Nab-paclitaxel, Placebo

                  Study Arms

                  Experimental: Arm E

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986504, Gemcitabine, Nab-paclitaxel

                  Study Arms

                  Placebo Comparator: Arm F

                  ASSIGNED INTERVENTION
                  • Drug: Gemcitabine, Nab-paclitaxel, Placebo
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