An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004284-27-ES

Enrollment

200

Registered

2021-12-10

Start date

2022-03-28

Completion date

Unknown

Last updated

2022-04-04

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), 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)). MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864

Interventions

Product Name: anti-CTLA-4 NF Probody mAb Product Code: BMS-986288 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available Current Sponsor code: BMS-986288 Other descriptive name

anti-CTLA-4 NF Probody mAb Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies Other protocol defined inclusion criteria apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160

Exclusion criteria

Exclusion criteria: - Participants with active, known or suspected autoimmune disease - Participants with other active malignancy requiring concurrent intervention - Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded Other protocol defined exclusion criteria apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors;Secondary Objective: - To characterize the Pharmacokinetic (PK) of BMS-986288 when administered alone and in combination with nivolumab - To assess the preliminary efficacy of BMS-986288 alone and in combination with nivolumab in advanced solid tumors using RECIST v1.1 - To measure T-regulatory cells (Tregs), and assess Treg change over time and in association with response;Primary end point(s): 1. 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;Timepoint(s) of evaluation of this end point: 1. Up to 2 years	—

Measure

Time frame

Main Objective: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors;Secondary Objective: - To characterize the Pharmacokinetic (PK) of BMS-986288 when administered alone and in combination with nivolumab - To assess the preliminary efficacy of BMS-986288 alone and in combination with nivolumab in advanced solid tumors using RECIST v1.1 - To measure T-regulatory cells (Tregs), and assess Treg change over time and in association with response;Primary end point(s): 1. 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;Timepoint(s) of evaluation of this end point: 1. Up to 2 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Maximum Observed Concentration (Cmax) of BMS-986288 2. Time of Maximum Observed Concentration (Tmax) of BMS-986288 3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 4. Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 5. Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 6. Trough Observed Concentrations (Ctrough) of BMS-986288 7. Total Body Clearance (CLT) of BMS-986288 8. Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 9. Accumulation Index (AI) of BMS-986288 10. Terminal Half-Life (T-HALF) of BMS-986288 11. Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 12. Objective Response Rate (ORR) of Participants 13. Duration of Response (DOR) of Participants 14. Progression-Free Survival (PFS) of Participants 15. Time to Response (TTR) of Participants 16 Percentage of change from baseline in T-regulatory cells (Tregs);Timepoint(s) of evaluation of this end point: 1. Up to 2 years 2. Up to 2 years 3. Up to 2 years 4. Up to 2 years 5. Up to 2 years 6. Up to 2 years 7. Up to 4 months 8. Up to 4 months 9. Up to 4 months 10. Up to 4 months 11. Up to 2 years 12. Up to 4 years 13. Up to 4 years 14. Up to 4 years 15. Up to 4 years 16. Up to 2 years	—

Measure

Time frame

Secondary end point(s): 1. Maximum Observed Concentration (Cmax) of BMS-986288 2. Time of Maximum Observed Concentration (Tmax) of BMS-986288 3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 4. Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 5. Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 6. Trough Observed Concentrations (Ctrough) of BMS-986288 7. Total Body Clearance (CLT) of BMS-986288 8. Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 9. Accumulation Index (AI) of BMS-986288 10. Terminal Half-Life (T-HALF) of BMS-986288 11. Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 12. Objective Response Rate (ORR) of Participants 13. Duration of Response (DOR) of Participants 14. Progression-Free Survival (PFS) of Participants 15. Time to Response (TTR) of Participants 16 Percentage of change from baseline in T-regulatory cells (Tregs);Timepoint(s) of evaluation of this end point: 1. Up to 2 years 2. Up to 2 years 3. Up to 2 years 4. Up to 2 years 5. Up to 2 years 6. Up to 2 years 7. Up to 4 months 8. Up to 4 months 9. Up to 4 months 10. Up to 4 months 11. Up to 2 years 12. Up to 4 years 13. Up to 4 years 14. Up to 4 years 15. Up to 4 years 16. Up to 2 years

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Countries

Argentina, Canada, Chile, France, Italy, Spain, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com+ 34 91 456 53 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026