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OpenTrials
Active, not recruiting

NCT Number: NCT07076121

A Study Comparing Navlimetostat (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)

The purpose of this study is to assess the safety and efficacy of Navlimetostat (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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Británico de Buenos Aires, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Navlimetostat

Drug

Specified dose on specified days

Other names: BMS-986504, MRTX1719

Gemcitabine

Drug

Specified dose on specified days

Nab-paclitaxel

Drug

Specified dose on specified days

Other names: Abraxane

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)

    Time frame: Up to 3 years after last participant is randomized

    Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)

  2. Overall Survival (OS)

    Time frame: Up to 3 years after last participant is randomized

    Defined as the time from the randomization date to the date of death from any cause

Secondary outcomes

  1. Objective Response (OR) as assessed by RECIST v1.1

    Time frame: Up to 3 years after last participant is randomized

  2. Duration of Response (DOR) as assessed by RECIST v1.1

    Time frame: Up to 3 years after last participant is randomized

    Defined as the time between the date of the first documentation of objective tumor response (complete response (CR) or partial response (PR)) and the date of disease progression or to death from any cause (whichever occurs first)

  3. Time to Objective Response (TTOR) as assessed by RECIST v1.1

    Time frame: Up to 3 years after last participant is randomized

    Defined as the time between randomization to the date of the first documentation of objective tumor response

  4. Disease control as assessed by RECIST v1.1

    Time frame: Up to 3 years after last participant is randomized

    Defined as the best overall response (BOR) of confirmed CR, PR, or stable disease (SD)

  5. Number of participants with treatment-related adverse events (TRAEs)

    Time frame: Up to 28 days after the last drug administration

  6. Number of participants with all-cause treatment-emergent adverse events (TEAEs)

    Time frame: Up to 28 days after the last drug administration

  7. Number of participants with treatment-emergent serious adverse events (TESAEs)

    Time frame: Up to 28 days after the last drug administration

  8. Number of participants with TEAEs leading to dose interruption, reduction, or discontinuation

    Time frame: Up to 28 days after the last drug administration

  9. Number of participants with laboratory abnormalities

    Time frame: Up to 28 days after the last drug administration

  10. PFS as assessed by RECIST v1.1

    Time frame: Up to 3 years after last participant is randomized

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Phase 2/3 Study Comparing Navlimetostat (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 Harboring Homozygous MTAP Deletion

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 21, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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