A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
- Conditions
- CancerMelanoma
- Interventions
- Drug: BMS-986253Biological: NivolumabBiological: IpilimumabOther: Placebo
- Registration Number
- NCT03400332
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 281
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1A: BMS-986253 + nivolumab BMS-986253 - Part 1C: BMS-986253 + nivolumab + ipilimumab Nivolumab - Part 2A: BMS-986253 + nivolumab + ipilimumab Ipilimumab - Part 1A: BMS-986253 + nivolumab Nivolumab - Part 2B: Placebo + nivolumab + ipilimumab Nivolumab - Part 1B: BMS-986253 + nivolumab BMS-986253 - Part 1C: BMS-986253 + nivolumab + ipilimumab Ipilimumab - Part 2A: BMS-986253 + nivolumab + ipilimumab BMS-986253 - Part 2A: BMS-986253 + nivolumab + ipilimumab Nivolumab - Part 1C: BMS-986253 + nivolumab + ipilimumab BMS-986253 - Part 1B: BMS-986253 + nivolumab Nivolumab - Part 2B: Placebo + nivolumab + ipilimumab Placebo - Part 2B: Placebo + nivolumab + ipilimumab Ipilimumab -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AE) Approximately 5 years Part 1
Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria Approximately 5 years Part 1
Incidence of deaths Approximately 5 years Part 1
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Approximately 5 years Part 1
Incidence of serious adverse events (SAE) Approximately 5 years Part 1
Incidence of AEs leading to discontinuation Approximately 5 years Part 1
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Approximately 5 years Part 1
Incidence of clinically significant changes in clinical laboratory results: Hematology tests Approximately 5 years Part 1
ORR based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized patients Approximately 5 years Part 2
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Approximately 5 years Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)
Serum biomarker concentration Approximately 5 years Part 1
Time of maximum observed serum concentration (Tmax) Approximately 5 years Part 1
Trough observed serum concentration at the end of the dosing interval (CTROUGH) Approximately 5 years Part 1
Maximum observed serum concentration (Cmax) Approximately 5 years Part 1
Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator Approximately 5 years Part 1
Incidence of anti-drug antibody (ADA) to BMS-986253 Approximately 5 years Part 1
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Approximately 5 years Part 1
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] Approximately 5 years Part 1
Duration of response (DOR) per response evaluation criteria in solid tumors (RECIST) v1.1 per investigator Approximately 5 years Part 1
Observed serum concentration at the end of a dosing interval (CTAU) Approximately 5 years Part 1
Incidence of AEs Approximately 5 years Part 2
Incidence of SAEs Approximately 5 years Part 2
Incidence of AEs leading to discontinuation Approximately 5 years Part 2
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Approximately 5 years Part 2
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Approximately 5 years Part 2
Incidence of death Approximately 5 years Part 2
Incidence of clinically significant changes in clinical laboratory results: Hematology tests Approximately 5 years Part 2
Trial Locations
- Locations (72)
Local Institution - 0007
🇺🇸Lakewood, Colorado, United States
Local Institution - 0087
🇺🇸Atlanta, Georgia, United States
Local Institution - 0025
🇺🇸New York, New York, United States
Local Institution - 0017
🇺🇸Eugene, Oregon, United States
Local Institution - 0096
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0020
🇨🇦Toronto, Ontario, Canada
Local Institution - 0036
🇧🇪Gent, Belgium
Local Institution - 0056
🇨🇦Montréal, Quebec, Canada
Local Institution - 0102
🇫🇷Toulouse, France
Local Institution - 0052
🇩🇪Mainz, Rheinland-Pfalz, Germany
Local Institution - 0019
🇬🇧Birmingham, West Midlands, United Kingdom
Local Institution - 0024
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0060
🇺🇸Boston, Massachusetts, United States
Comprehensive Cancer Centers Of Nevada
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0006
🇺🇸San Antonio, Texas, United States
Local Institution - 0097
🇦🇺Perth, Western Australia, Australia
Local Institution - 0028
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 0058
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0059
🇺🇸Springdale, Arkansas, United States
Local Institution - 0099
🇺🇸Los Angeles, California, United States
Local Institution - 0100
🇺🇸Atlanta, Georgia, United States
Local Institution - 0003
🇺🇸Lutherville, Maryland, United States
Local Institution - 0101
🇺🇸Marietta, Georgia, United States
Local Institution - 0012
🇺🇸Columbia, Maryland, United States
Local Institution - 0005
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0032
🇺🇸New Brunswick, New Jersey, United States
Local Institution - 0002
🇺🇸New York, New York, United States
Local Institution - 0009
🇺🇸Greenville, South Carolina, United States
Local Institution - 0001
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0014
🇺🇸Fort Worth, Texas, United States
Local Institution - 0011
🇺🇸Austin, Texas, United States
Local Institution - 0018
🇺🇸Houston, Texas, United States
Local Institution - 0015
🇺🇸Fairfax, Virginia, United States
Local Institution - 0013
🇺🇸Tyler, Texas, United States
Local Institution - 0008
🇺🇸Norfolk, Virginia, United States
Local Institution - 0088
🇦🇺Wollstonecraft, New South Wales, Australia
Local Institution - 0091
🇦🇺Ballarat Central, Australia
Local Institution - 0082
🇧🇪Kortrijk, Belgium
Local Institution - 0030
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0055
🇨🇦Toronto, Ontario, Canada
Local Institution - 0067
🇫🇷Marseille, Bouches-du-Rhône, France
Local Institution - 0085
🇫🇷Nantes, France
Local Institution - 0068
🇫🇷Paris, France
Local Institution - 0069
🇫🇷Villejuif, France
Local Institution - 0034
🇩🇪Berlin, Germany
Local Institution - 0053
🇩🇪Hamburg, Germany
Local Institution - 0043
🇮🇹Forlì, Italy
Local Institution - 0042
🇮🇹Milano, Italy
Local Institution - 0027
🇮🇹Napoli, Italy
Local Institution - 0026
🇮🇹Rozzano-milano, Italy
Local Institution - 0071
🇵🇱Krakow, Poland
Local Institution - 0077
🇵🇱Warszawa, Poland
Local Institution - 0022
🇪🇸Madrid, Spain
Local Institution - 0045
🇪🇸Madrid, Spain
Local Institution - 0023
🇪🇸Madrid, Spain
Local Institution - 0044
🇪🇸Malaga, Spain
Local Institution - 0021
🇪🇸Pamplona, Spain
Local Institution - 0047
🇪🇸Santiago de Compostela, Spain
Local Institution - 0049
🇸🇪Lund, Sweden
Local Institution - 0039
🇨🇭Zuerich, Switzerland
Local Institution - 0040
🇨🇭Lausanne, Switzerland
Local Institution - 0083
🇬🇧Glasgow, Lanarkshire, United Kingdom
Local Institution - 0010
🇺🇸Dallas, Texas, United States
Local Institution - 0078
🇨🇦Victoria, British Columbia, Canada
Local Institution - 0037
🇧🇪Bruxelles, Belgium
Local Institution - 0090
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0054
🇩🇪Tübingen, Baden-Württemberg, Germany
Local Institution - 0095
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0041
🇨🇭St.Gallen, Switzerland
Local Institution - 0004
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0076
🇺🇸Omaha, Nebraska, United States
Local Institution - 0029
🇨🇦Vancouver, British Columbia, Canada
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