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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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)

Status
Active
Cancer Type
Pancreatic Cancer
Trial Phase
Phase II
Phase III
Eligibility
, Male and Female
Study Type
Treatment
NCT ID
NCT07076121
Protocol IDs
CA240-0030 (primary)
2025-522598-12 ( Other Identifier ) (OTHER: EU CTR
U1111-1320-4708 ( Other Identifier ) (OTHER: WHO)
Study Sponsor
Bristol-Myers Squibb

Summary

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.

Eligibility

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.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


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