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An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400332
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.

Condition or disease Intervention/treatment Phase
Cancer Drug: BMS-986253 Biological: Nivolumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : November 26, 2023
Estimated Study Completion Date : November 26, 2023

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: Dose Finding
BMS-986253 administered in combination with Nivolumab
 Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Dose Expansion
BMS-986253 administered in combination with Nivolumab
 Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
  2. Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
  3. Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
  5. Incidence of deaths [ Time Frame: Approximately 5 years ]
  6. Incidence of labornatory abnormalities [ Time Frame: Approximately 5 years ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
  2. Median duration of response (mDOR) [ Time Frame: Approximately 5 years ]
  3. Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
  4. Serum biomarker concentration [ Time Frame: Approximately 5 years ]
  5. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
  6. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
  7. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
  8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
  9. Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
  10. Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 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 a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
  • At least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
  • Participants with active, known or suspected autoimmune disease
  • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

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): NCT03400332


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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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:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03400332    
Other Study ID Numbers: CA027-002
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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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