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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994601
Recruitment Status : Active, not recruiting
First Posted : June 21, 2019
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Advanced Cancer Drug: BMS-986288 Drug: Nivolumab Drug: Regorafenib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : April 14, 2024
Estimated Study Completion Date : May 14, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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: BMS-986288
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib 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


Outcome Measures
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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. 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


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. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment [ Time Frame: Up to 4 years ]
  12. Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
  13. Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
  14. Time to Response (TTR) by RECIST v1.1 by Investigator Assessment [ Time Frame: Up to 4 years ]
  15. DOR by RECIST v1.1 by blinded independent central review [ Time Frame: Up to 4 years ]
  16. PFS by RECIST v1.1 by blinded independent central review [ Time Frame: Up to 4 years ]
  17. Overall Survival (OS) by RECIST v1.1 by blinded independent central review [ Time Frame: Up to 4 years ]
  18. Incidence of Adverse Events (AEs) [ Time Frame: Up to 100 days following last dose of study treatment ]
  19. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 100 days following last dose of study treatment ]
  20. Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria [ Time Frame: Up to 100 days following last dose of study treatment ]
  21. Incidence of AEs leading to discontinuation [ Time Frame: Up to 100 days following last dose of study treatment ]
  22. Incidence of AEs leading to death [ Time Frame: Up to 100 days following last dose of study treatment ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994601


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03994601    
Other Study ID Numbers: CA043-001
2021-004284-27 ( EudraCT Number )
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action