A Phase 1 interventional study of BMS-986310 and Nivolumab in Advanced Cancer, sponsored by Bristol-Myers Squibb. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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.
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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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:
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
Drug: BMS-986310 · Biological: Nivolumab
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.
Drug: BMS-986310 · Biological: Nivolumab
Specified dose on specified days
Specified dose on specified days
Also known as: Opdivo, BMS-936558
Incidence of Adverse Events (AE)
Time frame: up to 3 years
Incidence of Serious Adverse Events (SAE)
Time frame: up to 3 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: up to 3 years
Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
Time frame: up to 3 years
Incidence of Laboratory abnormalities
Time frame: up to 3 years
Incidence of death
Time frame: up to 3 years
Objective response rate (ORR)
Time frame: up to 3 years
Median duration of response (mDOR)
Time frame: up to 3 years
Progression free survival rate (PFSR)
Time frame: up to 24 months
Maximum observed serum concentration (Cmax)
Time frame: up to 3 years
Observed serum concentration at the end of a dosing interval (Ctau)
Time frame: up to 3 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: up to 3 years
Apparent total body clearance (CLT/F)
Time frame: up to 3 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time frame: up to 3 years
AUC accumulation index (AI_AUC)
Time frame: up to 3 years
Cmax accumulation index (AI_Cmax)
Time frame: up to 3 years
Summary changes of prostaglandin E metabolite (PGEM) in urine
Time frame: up to 3 years
Summary changes of tumor necrosis factor (TNFa) in blood
Time frame: up to 3 years
Summary of PK parameters at T-HALF
Time frame: up to 3 years
Summary of PK parameter AUC(INF) after single dose
Time frame: up to 3 years
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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