A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Phase 1/2
949
about 7.1 years
18+
11 sites in CA, IA, NJ +4
What this study is about
This trial is testing a treatment called BMS-986340, either alone or with nivolumab or docetaxel, for people with advanced solid tumors. The goal is to determine the safety and best dose of BMS-986340.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take BMS-936558-01
- 2.Take BMS-986340
- 3.Take Docetaxel
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
docetaxel
infusion
Primary: Incidence of AEs leading to death, Incidence of AEs leading to discontinuation, Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria, Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs)
Secondary: Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator, Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator, Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator, PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)), PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau), PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax), PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU), PK parameters of BMS-986340 administered in combination with docetaxel: Cmax
Gastroenterology, Oncology