An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers

• ClinicalTrials.gov Identifier: NCT03400332
• Recruitment Status: Active, not recruiting
• First Posted: January 17, 2018
• Last Update Posted: June 22, 2020
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: January 12, 2018
• First Posted Date: January 17, 2018
• Last Update Posted Date: June 22, 2020
• Actual Study Start Date: January 31, 2018
• Estimated Primary Completion Date: November 26, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2018)

• Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
• Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
• Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
• Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
• Incidence of deaths [ Time Frame: Approximately 5 years ]
• Incidence of labornatory abnormalities [ Time Frame: Approximately 5 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 12, 2018)

• Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
• Median duration of response (mDOR) [ Time Frame: Approximately 5 years ]
• Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
• Serum biomarker concentration [ Time Frame: Approximately 5 years ]
• Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
• Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
• Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
• Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers
• Official Title: A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers
• Brief Summary: The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.
• 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: Cancer

Intervention

• Drug: BMS-986253
  Specified dose on specified days
• Biological: Nivolumab
  Specified dose on specified days
  Other Names:

  • BMS-936558
  • Opdivo

Study Arms

• Experimental: Dose Finding
  BMS-986253 administered in combination with Nivolumab
  Interventions:

  • Drug: BMS-986253
  • Biological: Nivolumab
• Experimental: Dose Expansion
  BMS-986253 administered in combination with Nivolumab
  Interventions:

  • Drug: BMS-986253
  • Biological: Nivolumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 27, 2019): 320
• Original Estimated Enrollment (submitted: January 12, 2018): 260
• Estimated Study Completion Date: November 26, 2023
• Estimated Primary Completion Date: November 26, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

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: Belgium, Canada, Germany, Italy, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03400332
• Other Study ID Numbers: CA027-002
• 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
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

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

• PRS Account: Bristol-Myers Squibb
• Verification Date: June 2020