Advanced solid tumors (squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), cutaneous melanoma, triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), urothelial carcinoma, gastric, esophageal, cervical, and colorectal cancer (CRC)).
Conditions
Brief summary
For Part 1, 2A, 2B: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities, For Part 2C: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by BICR
Detailed description
For Part 1, 2A, 2B: Maximum Observed Concentration (Cmax) of BMS-986288, For Part 1, 2A, 2B: Time of Maximum Observed Concentration (Tmax) of BMS-986288, For Part 1, 2A, 2B: Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288, For Part 1, 2A, 2B: Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288, For Part 1, 2A, 2B: Observed Concentration at the end of a Dosing Interval (Ctau) of BMS- 986288, For Part 1, 2A, 2B: Trough Observed Concentrations (Ctrough) of BMS-986288, For Part 1, 2A, 2B: Total Body Clearance (CLT) of BMS-986288, For Part 1, 2A, 2B: Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288, For Part 1, 2A, 2B: Accumulation Index (AI) of BMS-986288, For Part 1, 2A, 2B: Terminal Half-Life (T-HALF) of BMS-986288, For Part 1, 2A, 2B: Objective Response Rate (ORR) of Participants, For Part 1, 2A, 2B: Duration of Response (DOR) of Participants, For Part 1, 2A, 2B: Progression-Free Survival (PFS) of Participants, For Part 1, 2A, 2B: Time to Response (TTR) of Participants, For Part 2C: Objective Response Rate (ORR) by RECIST V1.1 by BICR, For Part 2C: Duration of Response (DOR) by RECIST V1.1 by BICR, For Part 2C: Progression-Free Survival (PFS) by RECIST V1.1 by BICR, For Part 2C: Overall Survival (OS) by RECIST V1.1 by BICR, For Part 2C: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation and death.
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGanti-CTLA-4 NF Probody® mAb
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Part 1, 2A, 2B: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities, For Part 2C: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by BICR | — |
Secondary
| Measure | Time frame |
|---|---|
| For Part 1, 2A, 2B: Maximum Observed Concentration (Cmax) of BMS-986288, For Part 1, 2A, 2B: Time of Maximum Observed Concentration (Tmax) of BMS-986288, For Part 1, 2A, 2B: Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288, For Part 1, 2A, 2B: Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288, For Part 1, 2A, 2B: Observed Concentration at the end of a Dosing Interval (Ctau) of BMS- 986288, For Part 1, 2A, 2B: Trough Observed Concentrations (Ctrough) of BMS-986288, For Part 1, 2A, 2B: Total Body Clearance (CLT) of BMS-986288, For Part 1, 2A, 2B: Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288, For Part 1, 2A, 2B: Accumulation Index (AI) of BMS-986288, For Part 1, 2A, 2B: Terminal Half-Life (T-HALF) of BMS-986288, For Part 1, 2A, 2B: Objective Response Rate (ORR) of Participants, For Part 1, 2A, 2B: Duration of Response (DOR) of Participants, For | — |
Countries
France, Italy, Spain
Outcome results
None listed