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

  • Clinicaltrials.gov identifier

    NCT03994601

  • Recruitment Status

    Recruiting

  • First Posted

    June 21, 2019

  • Last update posted

    April 25, 2022

Study Description

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.

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Drug: BMS-986288
    Drug: Nivolumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 344 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: April 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A BMS-986288
Drug: BMS-986288
Specified dose on specified days
Experimental: Arm B BMS-986288 in combination with Nivolumab
Drug: BMS-986288
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 2 years ]
  • 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years ]
  • 3. Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria [ Time Frame: Up to 2 years ]
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
  • 5. Incidence of AEs leading to death [ Time Frame: Up to 2 years ]
  • 6. Incidence of AEs leading to laboratory abnormalities [ Time Frame: Up to 2 years ]
  • Secondary Outcome Measures: 1. Maximum Observed Concentration (Cmax) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 2. Time of Maximum Observed Concentration (Tmax) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 4. Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 5. Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 6. Trough Observed Concentrations (Ctrough) of BMS-986288 [ Time Frame: Up to 2 years ]
  • 7. Total Body Clearance (CLT) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 8. Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 9. Accumulation Index (AI) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 10. Terminal Half-Life (T-HALF) of BMS-986288 [ Time Frame: Up to 4 months ]
  • 11. Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 [ Time Frame: Up to 2 years ]
  • 12. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment [ Time Frame: Up to 4 years ]
  • 13. Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
  • 14. Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
  • 15. Time to Response (TTR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
  • 16. Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 2 years ]

Eligibility Criteria

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

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 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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Colorado
University Of Colorado
Aurora

United States, Maryland
Johns Hopkins University
Baltimore

United States, Missouri
Washington University
Saint Louis

United States, New Jersey
Hackensack University Medical Center
Hackensack

Argentina, Buenos Aires
Local Institution
Ciudad Autónoma De Buenos Aires

Argentina, Cordoba
Local Institution
Río Cuarto

Argentina, Distrito Federal
Local Institution
ABB

Argentina, Distrito Federal
Local Institution
Buenos Aires

Argentina, Distrito Federal
Local Institution - 0012
Caba

Argentina, Distrito Federal
Local Institution
Capital

Argentina
Local Institution
Cordoba

Canada, Ontario
Local Institution - 0006
Toronto

Chile, Metropolitana
Local Institution - 0019
Santiago

Chile, Metropolitana
Local Institution - 0009
Santiago

Chile, Valparaiso
Local Institution
Viña del Mar

France
Local Institution
Bron

France
Local Institution
Marseille

France
Local Institution
Paris

France
Local Institution
Toulon Cedex

Italy
Local Institution
Ancona

Italy
Local Institution
Catanzaro

Italy
Local Institution
Milano

Italy
Local Institution
Milano

Italy
Local Institution
Monza

Spain
Local Institution
Madrid

Spain
Local Institution
Majadahonda

Spain
Local Institution
Valencia

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03994601 History of Changes
  • Other Study ID Numbers: CA043-001
  • First Posted: June 21, 2019 Key Record Dates
  • Last Update Posted: April 25, 2022
  • Last Verified: April 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No