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

• ClinicalTrials.gov Identifier: NCT03994601
• Recruitment Status: Active, not recruiting
• First Posted: June 21, 2019
• Last Update Posted: April 18, 2024
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: June 17, 2019
• First Posted Date: June 21, 2019
• Last Update Posted Date: April 18, 2024
• Actual Study Start Date: September 6, 2019
• Estimated Primary Completion Date: April 14, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2023)

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

• Original Primary Outcome Measures (submitted: June 20, 2019): 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 [ Time Frame: Up to 2 years ]

Current Secondary Outcome Measures (submitted: April 19, 2023)

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

Original Secondary Outcome Measures (submitted: June 20, 2019)

• Maximum Observed Concentration (Cmax) of BMS-986288 [ Time Frame: Up to 2 years ]
• Time of Maximum Observed Concentration (Tmax) of BMS-986288 [ Time Frame: 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 [ Time Frame: Up to 2 years ]
• Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 [ Time Frame: Up to 2 years ]
• Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 [ Time Frame: Up to 2 years ]
• Trough Observed Concentrations (Ctrough) of BMS-986288 [ Time Frame: Up to 2 years ]
• Total Body Clearance (CLT) of BMS-986288 [ Time Frame: Up to 4 months ]
• Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 [ Time Frame: Up to 4 months ]
• Accumulation Index (AI) of BMS-986288 [ Time Frame: Up to 4 months ]
• Terminal Half-Life (T-HALF) of BMS-986288 [ Time Frame: Up to 4 months ]
• Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288 [ Time Frame: Up to 2 years ]
• Objective Response Rate (ORR) of Participants [ Time Frame: Up to 4 years ]
• Duration of Response (DOR) of Participants [ Time Frame: Up to 4 years ]
• Progression-Free Survival (PFS) of Participants [ Time Frame: Up to 4 years ]
• Time to Response (TTR) of Participants [ Time Frame: Up to 4 years ]
• Percentage of change from baseline in T-regulatory cells (Tregs) [ Time Frame: Up to 2 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
• Official Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Cancer

Intervention

• Drug: BMS-986288
  Specified dose on specified days
• Drug: Nivolumab
  Specified dose on specified days
  Other Names:

  • Opdivo
  • BMS-936558
• Drug: Regorafenib
  Specified dose on specified days

Study Arms

• Experimental: Arm A: BMS-986288 Monotherapy
  Intervention: Drug: BMS-986288
• Experimental: Arm B: BMS-986288 in combination with Nivolumab
  Interventions:

  • Drug: BMS-986288
  • Drug: Nivolumab
• Experimental: Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
  Interventions:

  • Drug: BMS-986288
  • Drug: Nivolumab
  • Drug: Regorafenib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 19, 2023): 494
• Original Estimated Enrollment (submitted: June 20, 2019): 200
• Estimated Study Completion Date: May 14, 2025
• Estimated Primary Completion Date: April 14, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Canada, Chile, France, Italy, Spain, United States

Administrative Information

• NCT Number: NCT03994601
• Other Study ID Numbers: CA043-001; 2021-004284-27 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: April 2024