Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

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: NCT03369223
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: BMS-986249 Biological: Nivolumab Biological: Ipilimumab Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 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-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : September 19, 2024
Estimated Study Completion Date : September 19, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part 1A: BMS-986249 Biological: BMS-986249
Specified dose on specified days
Experimental: Part 1B: BMS-986249 + nivolumab (nivo) Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced or intermediate hepatocellular carcinoma (HCC)
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm B: BMS-986249 + nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
 Biological: BMS-986249
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm E: Nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 2.5 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2.5 years ]
  3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 2.5 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2.5 years ]
  5. Incidence of death [ Time Frame: Up to 4 years ]
  6. Number of participants with laboratory abnormalities [ Time Frame: Up to 2.5 years ]
  7. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
  8. Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2.5 years ]

Secondary Outcome Measures :
  1. Cmax (Maximum observed serum concentration) [ Time Frame: Up to 2 years ]
  2. Tmax (Time of maximum observed concentration) [ Time Frame: Up to 2 years ]
  3. AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) [ Time Frame: Up to 2 years ]
  4. ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer) [ Time Frame: Up to 4 years ]
  5. Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  6. Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  7. Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) [ Time Frame: Up to 4 years ]
  8. Incidence of AEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  9. Incidence of SAEs in Part 2 of Study [ Time Frame: Up to 2.5 years ]
  10. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
  11. Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
  12. Number of participants with clinical laboratory abnormalities Part 2 of study [ Time Frame: Up to 2.5 years ]
  13. Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • 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 tumor type, if such a therapy exists
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
  • Other active malignancy requiring concurrent intervention
  • Prior organ allograft
  • Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03369223


Contacts
Layout table for location contacts
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 48 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03369223    
Other Study ID Numbers: CA030-001
2018-000416-21 ( EudraCT Number )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Antibodies
Antineoplastic Agents
Immunologic Factors
 Nivolumab
Antibodies, Monoclonal
Physiological Effects of Drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action