Study Summary
This trial is testing a new drug to see if it is safe and works well when used alone or with another existing cancer drug.
Video Summary
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 9 Secondary · Reporting Duration: Up to 24 months
Up to 100 days
Number of participants with AEs leading to discontinuation
Number of participants with adverse events (AEs)
Number of participants with death
Number of participants with serious adverse events (SAEs)
Up to 14 days
Incidence of anti-drug antibody (ADAs)
Maximum observed plasma concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)
Trough observed plasma concentration (Ctrough)
Up to 24 months
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
Disease control rate (DCR)
Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma
Objective response rate (ORR)
Up to 28 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Part 1A: BMS-986406 (Monotherapy Dose Escalation)
1 of 4
Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
1 of 4
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
1 of 4
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
1 of 4
Experimental Treatment
112 Total Participants · 4 Treatment Groups
Primary Treatment: BMS-986406 · No Placebo Group · Phase 1
Part 1A: BMS-986406 (Monotherapy Dose Escalation)
Biological
Experimental Group · 1 Intervention: BMS-986406 · Intervention Types: BiologicalPart 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)Experimental Group · 2 Interventions: Nivolumab, BMS-986406 · Intervention Types: Biological, Biological
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)Experimental Group · 2 Interventions: Nivolumab, BMS-986406 · Intervention Types: Biological, Biological
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)Experimental Group · 2 Interventions: Nivolumab, BMS-986406 · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5260
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,496 Previous Clinical Trials
3,930,215 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have normal organ function.
Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.
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Conditions
Cancer Related
Treatments