Advanced Cancer
Conditions
Brief summary
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.
Interventions
DRUGBMS-986310
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy. * ECOG performance status less than or equal to 1 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
* History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors. * Participants with an active, known or suspected autoimmune disease. * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | 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 |
| Summary changes of prostaglandin E metabolite (PGEM) in urine | up to 3 years |
| Objective response rate (ORR) | up to 3 years |
| Median duration of response (mDOR) | up to 3 years |
| Progression free survival rate (PFSR) | 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 |
Countries
Belgium, Canada, United States
Outcome results
None listed