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A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer

ConditionsDiffuse Pleural MesotheliomaGastroesophageal CarcinomaUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in people with metastatic/advanced unresectable MTAP-deleted solid tumor cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diffuse pleural mesothelioma (DPM)

Gastroesophageal carcinoma (GEC) including adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.

PD-L1 CPS ≥1 (using clone 73-10, DAKO)

HER2 overexpression negative (using clone 4B5, Ventana): HER2 IHC 0-1+, or HER2 2+ with ISH showing HER2:CEP17 ratio <2 and average HER2 copy number <6.0 signals/cell

Disqualifiers

Prior treatment with PRMT5i or MAT2Ai

Symptomatic CNS metastases

Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression and the patient is on a stable dose of corticosteroids

Received palliative radiation therapy within 3 days prior to initiation of study treatment or definitive SRS including CNS SRS within 14 days prior to initiation of study treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986504

    Drug

    BMS-986504 PO daily

  • Ipilimumab

    Drug

    Ipilimumab (1mg/kg Q6wk)

  • Nivolumab

    Drug

    Nivolumab (360mg flat dose Q3wk)

  • 5-FU

    Drug

    are continued until disease progression or intolerance

  • Leucovorin

    Drug

    are continued until disease progression or intolerance

  • Oxaliplatin

    Drug

    are continued until disease progression or intolerance

  • Gemcitabine

    Drug

    Gemcitabine are given for a maximum of 6 cycles

  • Platinum

    Drug

    Platinum are given for a maximum of 6 cycles

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Diffuse pleural mesothelioma (DPM): first-line treatmentExperimental treatment 3 interventions
Group B: Gastroesophageal carcinoma (GEC): first-line treatmentExperimental treatment 5 interventions
Group C: Urothelial carcinoma (UC): second- or third-line treatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

determine a recommended phase II dose (RP2D) of BMS-986504 in combination with standard-of-care therapy

The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 will be used to determine all adverse events and dose-limiting toxicities.

Time frame
2 years

Secondary outcomes

1

Overall Response Rate (ORR)

The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria will be used to determine ORR .

Time frame
2 years
2

Progression-free survival (PFS)

Determined by RECIST v1.1 or modified (m)RECIST criteria. Progression-free survival (PFS): is defined as the duration of time from the start of treatment to disease progression or death.

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Memorial Sloan Kettering Cancer Center

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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