A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
- Conditions
- Advanced Cancer
- Interventions
- Registration Number
- NCT03369223
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 607
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2A Arm D: ipilimumab + nivo then nivo Ipilimumab Previously untreated unresectable stage III-IV melanoma Part 2A Arm D: ipilimumab + nivo then nivo Nivolumab Previously untreated unresectable stage III-IV melanoma Part 1A: BMS-986249 BMS-986249 - Part 1B: BMS-986249 + nivolumab (nivo) Nivolumab - Part 2A Arm C: BMS-986249 + nivo BMS-986249 Previously untreated unresectable stage III-IV melanoma Part 2A Arm A: BMS-986249 + nivo then nivo BMS-986249 * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm Part 2A Arm B: BMS-986249 + nivo BMS-986249 * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm Part 2A Arm B: BMS-986249 + nivo Nivolumab * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm Part 2A Arm E: Nivo Nivolumab * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm Part 1B: BMS-986249 + nivolumab (nivo) BMS-986249 - Part 2A Arm C: BMS-986249 + nivo Nivolumab Previously untreated unresectable stage III-IV melanoma Part 2A Arm F: BMS-986249 + nivo BMS-986249 Previously untreated unresectable stage III-IV melanoma Part 2A Arm F: BMS-986249 + nivo Nivolumab Previously untreated unresectable stage III-IV melanoma Part 2B Cohort 1: BMS-986249 + nivo BMS-986249 Advanced or intermediate hepatocellular carcinoma (HCC) Part 2B Cohort 1: BMS-986249 + nivo Nivolumab Advanced or intermediate hepatocellular carcinoma (HCC) Part 2B Cohort 2: BMS-986249 + nivo BMS-986249 Metastatic castration-resistant prostate cancer (CRPC) Part 2B Cohort 2: BMS-986249 + nivo Nivolumab Metastatic castration-resistant prostate cancer (CRPC) Part 2B Cohort 3: BMS-986249 + nivo BMS-986249 Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) Part 2B Cohort 3: BMS-986249 + nivo Nivolumab Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) Part 2A Arm A: BMS-986249 + nivo then nivo Nivolumab * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
- Primary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation Up to 2.5 years Incidence of treatment-related Grade 3-5 AEs Within 24 weeks Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 2.5 years Incidence of death Up to 4 years Number of participants with laboratory abnormalities Up to 2.5 years Incidence of Serious Adverse Events (SAEs) Up to 2.5 years Incidence of Adverse Events (AEs) Up to 2.5 years Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria Up to 2.5 years
- Secondary Outcome Measures
Name Time Method Cmax (Maximum observed serum concentration) Up to 2 years Tmax (Time of maximum observed concentration) Up to 2 years AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) Up to 2 years Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) Up to 4 years Incidence of SAEs in Part 2 of Study Up to 2.5 years ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer) Up to 4 years Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) Up to 4 years Incidence of AEs leading to discontinuation in Part 2 of study Up to 2.5 years Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer) Up to 4 years Incidence of AEs in Part 2 of Study Up to 2.5 years Time to Deterioration (TTD) in Part 2 of study Up to 4 Years Incidence of death in Part 2 of study Up to 4 years Number of participants with clinical laboratory abnormalities Part 2 of study Up to 2.5 years
Trial Locations
- Locations (45)
Local Institution - 0025
🇦🇺Frankston, Victoria, Australia
Local Institution - 0056
🇨🇦Ottawa, Ontario, Canada
Local Institution - 0020
🇮🇹Napoli, Italy
Local Institution - 0049
🇮🇹Siena, Italy
Local Institution - 0005
🇺🇸Aurora, Colorado, United States
Local Institution - 0006
🇺🇸Denver, Colorado, United States
Local Institution - 0017
🇺🇸Miami, Florida, United States
Local Institution - 0024
🇺🇸Baltimore, Maryland, United States
Local Institution - 0001
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0002
🇺🇸New York, New York, United States
Local Institution - 0003
🇺🇸New York, New York, United States
Local Institution - 0029
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0013
🇺🇸Eugene, Oregon, United States
Local Institution - 0004
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0008
🇺🇸Greenville, South Carolina, United States
Local Institution - 0010
🇺🇸Austin, Texas, United States
Local Institution - 0009
🇺🇸Dallas, Texas, United States
Local Institution - 0021
🇺🇸Houston, Texas, United States
Local Institution - 0016
🇺🇸San Antonio, Texas, United States
Local Institution - 0011
🇺🇸Tyler, Texas, United States
Local Institution - 0012
🇺🇸Leesburg, Virginia, United States
Local Institution - 0007
🇺🇸Norfolk, Virginia, United States
Local Institution - 0018
🇺🇸Vancouver, Washington, United States
Local Institution - 0038
🇦🇷Buenos Aires, Distrito Federal, Argentina
Local Institution - 0052
🇦🇷Caba, Distrito Federal, Argentina
Local Institution - 0037
🇦🇷Buenos Aires, Argentina
Local Institution - 0015
🇦🇺North Sydney, New South Wales, Australia
Local Institution - 0014
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0047
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0026
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0036
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0039
🇫🇮Helsinki, Finland
Local Institution - 0030
🇩🇪Essen, Germany
Local Institution - 0035
🇩🇪Hamburg, Germany
Local Institution - 0031
🇩🇪Heidelberg, Germany
Local Institution - 0048
🇮🇹Milan, Italy
Local Institution - 0040
🇵🇱Warszawa, Poland
Local Institution - 0045
🇷🇴Bucharest, Romania
Local Institution - 0041
🇷🇴Craiova, Romania
Local Institution - 0042
🇪🇸Badalona, Barcelona [Barcelona], Spain
Local Institution - 0022
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0044
🇪🇸Barcelona, Spain
Local Institution - 0023
🇪🇸Madrid, Spain
Local Institution - 0050
🇪🇸Madrid, Spain
Local Institution - 0043
🇪🇸Malaga, Spain