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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002108-15 | EudraCT Number |
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The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Part 1: BMS-986310 + Nivolumab Combination Dose Escalation Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy. Sub-Study B: A cohort of PD[L]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab |
|
| Cohort Expansion | Experimental | Part 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1. BMS-986310 + Nivolumab combination will be administered in specific patient populations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986310 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AE) | up to 3 years | |
| Incidence of Serious Adverse Events (SAE) | up to 3 years | |
| Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | up to 3 years | |
| Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC) | up to 3 years | |
| Incidence of Laboratory abnormalities | up to 3 years | |
| Incidence of death | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | up to 3 years | |
| Median duration of response (mDOR) | up to 3 years | |
| Progression free survival rate (PFSR) |
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Inclusion Criteria:
Part 1 and Sub-study B:
i) Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible.
ii) Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, in one of the following tumor types: Renal cell carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck (SCCHN), and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy
Sub-study A:
i) Participants must be newly diagnosed, no prior history of treatment for bladder cancer ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor.
iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure or mixed histology urothelial carcinoma Part 2 - Patients with relapsed / refractory solid tumors where no other standard of care treatment option is available.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| Hackensack University Medical Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Nivolumab |
| Biological |
Specified dose on specified days |
|
|
| up to 24 months |
| Maximum observed serum concentration (Cmax) | up to 3 years |
| Observed serum concentration at the end of a dosing interval (Ctau) | up to 3 years |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | up to 3 years |
| Apparent total body clearance (CLT/F) | up to 3 years |
| Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] | up to 3 years |
| AUC accumulation index (AI_AUC) | up to 3 years |
| Cmax accumulation index (AI_Cmax) | up to 3 years |
| Summary changes of prostaglandin E metabolite (PGEM) in urine | up to 3 years |
| Summary changes of tumor necrosis factor (TNFa) in blood | up to 3 years |
| Summary of PK parameters at T-HALF | up to 3 years |
| Summary of PK parameter AUC(INF) after single dose | up to 3 years |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Ghent | 9000 | Belgium |
| Local Institution | Toronto | Ontario | M5G 1Z5 | Canada |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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