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  • NCT07076121

Not Yet Recruiting

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) - CA240-0030

Aktualisiert: 18 August, 2025   |   ClinicalTrials.gov

Zusammenfassung zum Ausdrucken

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Studiendetails

  • Phase 2/Phase 3

    Phase

  • Geschlecht(er)

  • 18+

    Altersgruppe

  • 140

    Standort(e)

  • Not Yet Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: Arm A
Drug: BMS-986504, Gemcitabine, Nab-paclitaxel
Experimental: Arm B
Drug: BMS-986504, Gemcitabine, Nab-paclitaxel
Placebo Comparator: Arm C
Drug: Gemcitabine, Nab-paclitaxel, Placebo
Placebo Comparator: Arm D
Drug: Gemcitabine, Nab-paclitaxel, Placebo
Experimental: Arm E
Drug: BMS-986504, Gemcitabine, Nab-paclitaxel
Placebo Comparator: Arm F
Drug: Gemcitabine, Nab-paclitaxel, Placebo

Wichtigste Eignungskriterien

Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC). - Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue. - Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1). - Participants must not have received any systemic anticancer treatments in the metastatic setting. - 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. - Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization. Exclusion Criteria: - Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening. - Other protocol-defined Inclusion/Exclusion criteria apply.

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