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

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ClinicalTrials.gov Identifier: NCT03994601
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : February 17, 2020
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 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-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 : July 31, 2019
Estimated Primary Completion Date : February 13, 2023
Estimated Study Completion Date : February 13, 2024

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

Drug: Nivolumab
Specified dose on specified days
Other Name: Opdivo/BMS 936558


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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) of Participants [ Time Frame: Up to 4 years ]
  13. Duration of Response (DOR) of Participants [ Time Frame: Up to 4 years ]
  14. Progression-Free Survival (PFS) of Participants [ Time Frame: Up to 4 years ]
  15. Time to Response (TTR) of Participants [ 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
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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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
  • Participants must have 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:

  • Participants with active, known or suspected autoimmune disease
  • Participants with other active malignancy requiring concurrent intervention
  • Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol defined inclusion/exclusion criteria could 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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Stephen Leong, Site 0005         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dung Le, Site 0002         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Andrea Wang-gillam, Site 0004         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0001         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: Site 0006         
Sponsors and Collaborators
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
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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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