Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

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 : February 6, 2020
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 : 375 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 5, 2017
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : July 15, 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 day
Experimental: Part 1B: BMS-986249+nivolumab (nivo) Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm A: BMS-986249+nivo then nivo Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm B: BMS-986249+nivo Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm C: BMS-986249+nivo Biological: BMS-986249
specified dose on specified day

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part 2A Arm D: ipilimumab+nivo then nivo 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 E: Nivo 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 (AE) [ Time Frame: up to 2.5 years ]
  2. Incidence of Serious Adverse Events (SAE) [ 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 2.5 years ]
  6. Incidence of Laboratory abnormalities [ Time Frame: up to 4 years ]
  7. Incidence of treatment-related Grade 3-5 AEs [ Time Frame: At 24 weeks ]
  8. Objective Response Rate as assessed by investigator using (Response Evaluation Criteria in Solid Tumors) RECIST v1.1 [ Time Frame: up to 4 years ]

Secondary Outcome Measures :
  1. Cmax (Maximum observed serum concentration) of BMS-986249 [ Time Frame: up to 2 years ]
  2. Tmax (Time of maximum observed concentration) of BMS-986249 [ 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) of BMS-986249 [ Time Frame: up to 2 years ]
  4. AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) of BMS-986249 [ Time Frame: up to 2 years ]
  5. Ctau (Observed concentration at the end of a dosing interval) of BMS-986249 [ Time Frame: up to 2 years ]
  6. Ctrough (Trough observed concentrations) of BMS-986249 [ Time Frame: up to 2 years ]
  7. Objective Response Rate (ORR) [ Time Frame: up to 4 years ]
  8. Duration of response (DOR) [ Time Frame: up to 4 years ]
  9. Progression-Free survival (PFS) [ Time Frame: up to 4 years ]
  10. Time to response (TTR) [ Time Frame: up to 4 years ]
  11. Total body clearance (CLT) of BMS-986249 [ Time Frame: up to 2 years ]
  12. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) of BMS-986249 [ Time Frame: up to 2 years ]
  13. Terminal serum half-life if data permit (T-HALF) of BMS-986249 [ Time Frame: up to 2 years ]
  14. Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] of BMS-986249 [ Time Frame: up to 2 years ]
  15. Incidence of Adverse Events (AE) in Part 2 of Study [ Time Frame: up to 2.5 years ]
  16. Incidence of Serious Adverse Events (SAEs) [ Time Frame: up to 2.5 years ]
  17. Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: up to 2.5 years ]
  18. Incidence of Deaths [ Time Frame: up to 2.5 years ]
  19. Incidence of laboratory abnormalities [ Time Frame: up to 4 years ]
  20. Time to Deterioration (TTD) [ 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

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 and have at least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Some 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 solid tumor histologies
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some patients
  • Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Participants with primary CNS malignancies, tumors with CNS metastases as the only site of disease, active brain metastases, or leptomeningeal metastasis will be excluded
  • Active, known, or suspected autoimmune disease
  • Participants with other active malignancy requiring concurrent intervention.
  • Prior organ allograft.

Other protocol defined inclusion/exclusion criteria could 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: 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
Show Show 31 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:
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

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: February 6, 2020
Last Verified: February 2020

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
Antibodies
Immunologic Factors
 Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents