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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: Regorafenib; Drug: Nivolumab; Drug: BMS-986288

• Study Type: Interventional
• Enrollment (Estimated): 494
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1431
    • Local Institution - 0017
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution - 0016
  • Buenos Aires
    • Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina, 1426
      • Local Institution - 0011
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1096AAS
      • Local Institution - 0074
  • Cordoba
    • Córdoba, Cordoba, Argentina, X5000HXL
      • Local Institution - 0014
    • Río Cuarto, Cordoba, Argentina, 5800
      • Local Institution - 0013
  • Distrito Federal
    • ABB, Distrito Federal, Argentina, C1199
      • Local Institution - 0008
    • Caba, Distrito Federal, Argentina, C1430
      • Local Institution - 0012
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0006
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Local Institution - 0046
    • Montréal, Quebec, Canada, H2X 0A9
      • Local Institution - 0042
• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7510032
      • Local Institution - 0019
    • Santiago, Metropolitana, Chile, 8420383
      • Local Institution - 0009
  • Región Metropolitana De Santiago
    • Santiago, Región Metropolitana De Santiago, Chile, 7500921
      • Local Institution - 0036
    • Santiago, Región Metropolitana De Santiago, Chile, 7620002
      • Local Institution - 0035
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • Local Institution - 0010
• France
  • Bron Cedex, France, 69677
    • Local Institution - 0018
  • Marseille, France, 13915
    • Local Institution - 0026
  • Paris, France, 75248
    • Local Institution - 0015
  • Toulon, France, 83100
    • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
  • Gironde
    • Bordeaux, Gironde, France, 33075
      • Local Institution - 0034
  • Loire-Atlantique
    • Saint-Herblain, Loire-Atlantique, France, 44800
      • Local Institution - 0022
• Italy
  • Ancona, Italy, 60126
    • Local Institution - 0028
  • Catanzaro, Italy, 88100
    • Local Institution - 0033
  • Milan, Italy, 20162
    • Local Institution - 0031
  • Roma, Italy, 00168
    • Local Institution - 0039
  • Lombardia
    • Milan, Lombardia, Italy, 20133
      • Local Institution - 0040
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Local Institution - 0038
• Spain
  • Madrid, Spain, 28041
    • Local Institution - 0023
  • Majadahonda, Spain, 28222
    • Local Institution - 0024
  • Sevilla, Spain, 41013
    • Local Institution - 0055
  • València, Spain, 46026
    • Local Institution - 0025
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Local Institution - 0056
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08036
      • Local Institution - 0054
• United States
  • California
    • Costa Mesa, California, United States, 92627
      • Local Institution - 0075
    • Orange, California, United States, 92868
      • Local Institution - 0050
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Local Institution - 0005
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Local Institution - 0002
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Local Institution - 0004
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: BMS-986288 Monotherapy	Drug: BMS-986288; Specified dose on specified days
Experimental: Arm B: BMS-986288 in combination with Nivolumab	Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: BMS-986288; Specified dose on specified days
Experimental: Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib	Drug: Regorafenib; Specified dose on specified days; Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: BMS-986288; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Events (SAEs)		Up to 2 years
Incidence of AEs leading to discontinuation		Up to 2 years
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 death		Up to 2 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review	Part 2C	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Concentration (Cmax) of BMS-986288	Up to 2 years
Time of Maximum Observed Concentration (Tmax) of BMS-986288	Up to 2 years
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
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
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
Accumulation Index (AI) of BMS-986288	Up to 4 months
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
Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment	Up to 4 years
Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment	Up to 4 years
Time to Response (TTR) 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 meeting protocol-defined Dose Limiting Toxicities (DLT) criteria	Up to 100 days following last dose of study treatment
Incidence of AEs leading to discontinuation	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Estimated): April 14, 2024
• Study Completion (Estimated): May 14, 2025

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA043-001; 2021-004284-27 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No