Health Trials

A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.

Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.

Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.

Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.

Disqualifiers

Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.

Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).

Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.

Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.

Trial design

Design model

Single group

Treatments tested in this trial

  • BMS-986504

    Drug

    Specified dose on specified days

  • Daraxonrasib

    Drug

    Specified dose on specified days

  • Nivolumab + Relatlimab FDC

    Drug

    Specified dose on specified days

  • Temozolomide

    Drug

    Specified dose on specified days

  • Pumitamig

    Drug

    Specified dose on specified days

  • Pemetrexed

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Nab-paclitaxel

    Drug

    Specified dose on specified days

  • Gemcitabine

    Drug

    Specified dose on specified days

  • Paclitaxel

    Drug

    Specified dose on specified days

Treatment groups

260 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1aExperimental treatment 1 intervention
Group B: Part 1bExperimental treatment 1 intervention
Group C: Part 2: Cohort 1Experimental treatment 6 interventions
Group D: Part 2: Cohort 2aExperimental treatment 2 interventions
Group E: Part 2: Cohort 2bExperimental treatment 2 interventions
Group F: Part 2: Cohort 2cExperimental treatment 4 interventions
Group G: Part 2: Cohort 3Experimental treatment 2 interventions
Group H: Part 2: Cohort 4Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number of participants who achieve Objective Response (OR)

OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1

Time frame
Up to approximately 2 years
2

Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria

Time frame
Up to approximately 2 years
3

Part 2: Number of participants with adverse events (AE)

Time frame
Up to approximately 2 years
4

Part 2: Number of participants with Serious AEs (SAEs)

Time frame
Up to approximately 2 years

Secondary outcomes

1

Part 1 and 2: Time to objective response (TTOR)

Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1

Time frame
Up to approximately 2 years
2

Part 1 and 2: Duration of response (DOR)

Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1

Time frame
Up to approximately 2 years
3

Part 1 and 2: Number of participants who achieve disease control (DC)

Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1

Time frame
Up to approximately 2 years
4

Part 1: Number of participants with adverse events (AE)

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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