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

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: BMS-986288; Drug: Nivolumab; Drug: Regorafenib

• Registration Number: NCT03994601
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Study Start: 2019-09-06
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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
• 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

Exclusion Criteria

• Active, known or suspected autoimmune disease
• Active malignancy requiring concurrent intervention
• Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: BMS-986288 Monotherapy	BMS-986288	-
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib	BMS-986288	-
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib	Regorafenib	-
Arm B: BMS-986288 in combination with Nivolumab	Nivolumab	-
Arm B: BMS-986288 in combination with Nivolumab	BMS-986288	-
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 2 years
Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria	Up to 2 years
Incidence of AEs leading to discontinuation	Up to 2 years
Incidence of Serious Adverse Events (SAEs)	Up to 2 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review	Up to 2 years	Part 2C
Incidence of AEs leading to death	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of AEs leading to discontinuation	Up to 100 days following last dose of study treatment
Maximum Observed Concentration (Cmax) of BMS-986288	Up to 2 years
Time of Maximum Observed Concentration (Tmax) of BMS-986288	Up to 2 years
Accumulation Index (AI) of BMS-986288	Up to 4 months
Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment	Up to 4 years
DOR by RECIST v1.1 by blinded independent central review	Up to 4 years
PFS by RECIST v1.1 by blinded independent central review	Up to 4 years
Overall Survival (OS) by RECIST v1.1 by blinded independent central review	Up to 4 years
Incidence of Adverse Events (AEs)	Up to 100 days following last dose of study treatment
Incidence of Serious Adverse Events (SAEs)	Up to 100 days following last dose of study treatment
Incidence of AEs leading to death	Up to 100 days following last dose of study treatment
Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288	Up to 2 years
Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288	Up to 2 years
Total Body Clearance (CLT) of BMS-986288	Up to 4 months
Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288	Up to 4 months
Time to Response (TTR) by RECIST v1.1 by Investigator Assessment	Up to 4 years
Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria	Up to 100 days following last dose of study treatment
Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment	Up to 4 years
Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288	Up to 2 years
Trough Observed Concentrations (Ctrough) of BMS-986288	Up to 2 years
Terminal Half-Life (T-HALF) of BMS-986288	Up to 4 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment	Up to 4 years

Trial Locations

Locations (40)

Local Institution - 0075; 🇺🇸 Costa Mesa, California, United States

Local Institution - 0050; 🇺🇸 Orange, California, United States

Local Institution - 0024; 🇪🇸 Majadahonda, Spain

Local Institution - 0005; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0074; 🇦🇷 Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Local Institution - 0004; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0012; 🇦🇷 Caba, Distrito Federal, Argentina

Local Institution - 0006; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0035; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0034; 🇫🇷 Bordeaux, Gironde, France

Local Institution - 0010; 🇨🇱 Viña del Mar, Valparaiso, Chile

Local Institution - 0040; 🇮🇹 Milan, Lombardia, Italy

Local Institution - 0028; 🇮🇹 Ancona, Italy

Local Institution - 0015; 🇫🇷 Paris, France

Local Institution - 0038; 🇮🇹 Padova, Veneto, Italy

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer; 🇫🇷 Toulon, France

Local Institution - 0054; 🇪🇸 Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0056; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0023; 🇪🇸 Madrid, Spain

Local Institution - 0055; 🇪🇸 Sevilla, Spain

Local Institution - 0025; 🇪🇸 València, Spain

Local Institution - 0031; 🇮🇹 Milan, Italy

Local Institution - 0046; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0002; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0001; 🇺🇸 Hackensack, New Jersey, United States

Local Institution - 0011; 🇦🇷 Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina

Local Institution - 0013; 🇦🇷 Río Cuarto, Cordoba, Argentina

Local Institution - 0016; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0042; 🇨🇦 Montréal, Quebec, Canada

Local Institution - 0019; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0014; 🇦🇷 Córdoba, Cordoba, Argentina

Local Institution - 0017; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0022; 🇫🇷 Saint-Herblain, Loire-Atlantique, France

Local Institution - 0026; 🇫🇷 Marseille, France

Local Institution - 0033; 🇮🇹 Catanzaro, Italy

Local Institution - 0009; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0039; 🇮🇹 Roma, Italy

Local Institution - 0008; 🇦🇷 ABB, Distrito Federal, Argentina

Local Institution - 0018; 🇫🇷 Bron Cedex, France

Local Institution - 0036; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile