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Ícono de BMS, estudio Activo, no reclutando

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ID del estudio 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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Lo sentimos, este estudio ya no acepta nuevos participantes, pero aún está en curso.
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Resumen

  • Phase 2/Phase 3
  • Ícono de género masculino y femenino
  • 18+
  • Ícono de BMS, estudio Activo, no reclutando
    Active, Not Recruiting

Descripción general

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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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • 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.

              Criterios de exclusión

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

                  Opciones de tratamiento

                  Brazos del estudio

                  INTERVENCIÓN ASIGNADA

                  Brazos del estudio

                  Experimental: Arm A

                  INTERVENCIÓN ASIGNADA
                  • Drug: BMS-986504, Gemcitabine, Nab-paclitaxel

                  Brazos del estudio

                  Experimental: Arm B

                  INTERVENCIÓN ASIGNADA
                  • Drug: BMS-986504, Gemcitabine, Nab-paclitaxel

                  Brazos del estudio

                  Placebo Comparator: Arm C

                  INTERVENCIÓN ASIGNADA
                  • Drug: Gemcitabine, Nab-paclitaxel, Placebo

                  Brazos del estudio

                  Placebo Comparator: Arm D

                  INTERVENCIÓN ASIGNADA
                  • Drug: Gemcitabine, Nab-paclitaxel, Placebo

                  Brazos del estudio

                  Experimental: Arm E

                  INTERVENCIÓN ASIGNADA
                  • Drug: BMS-986504, Gemcitabine, Nab-paclitaxel

                  Brazos del estudio

                  Placebo Comparator: Arm F

                  INTERVENCIÓN ASIGNADA
                  • Drug: Gemcitabine, Nab-paclitaxel, Placebo

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