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A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508954-25-00
Acronym
CA043-001
Enrollment
96
Registered
2024-01-16
Start date
2022-05-11
Completion date
2024-08-20
Last updated
2024-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumors (squamous cell carcinoma of the head and neck (SCCHN), and colorectal cancer (CRC))., cervical, cutaneous melanoma, esophageal, gastric, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), triple-negative breast cancer (TNBC), urothelial carcinoma

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
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Source: EU CTIS · Data processed: Feb 4, 2026