A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1A: BMS-986253 + nivolumab
|
Drug: BMS-986253
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
Experimental: Part 1B: BMS-986253 + nivolumab
|
Drug: BMS-986253
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab
|
Drug: BMS-986253
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab
Specified dose on specified days
Other Names:
|
Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab
|
Drug: BMS-986253
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab
Specified dose on specified days
Other Names:
|
Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab
Specified dose on specified days
Other Names:
Other: Placebo
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events (AE) [Approximately 5 years]
Part 1
- Incidence of serious adverse events (SAE) [Approximately 5 years]
Part 1
- Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [Approximately 5 years]
Part 1
- Incidence of AEs leading to discontinuation [Approximately 5 years]
Part 1
- Incidence of deaths [Approximately 5 years]
Part 1
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Approximately 5 years]
Part 1
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Approximately 5 years]
Part 1
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Approximately 5 years]
Part 1
- 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, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1
Secondary Outcome Measures
- Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Approximately 5 years]
Part 1 and Part 2
- Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 [Approximately 5 years]
Part 1
- Incidence of anti-drug antibody (ADA) to BMS-986253 [Approximately 5 years]
Part 1 and Part 2
- Serum biomarker concentration [Approximately 5 years]
Part 1
- Maximum observed serum concentration (Cmax) [Approximately 5 years]
Part 1 and Part 2
- Time of maximum observed serum concentration (Tmax) [Approximately 5 years]
Part 1 and Part 2
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Approximately 5 years]
Part 1 and Part 2
- Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [Approximately 5 years]
Part 1 and Part 2
- Observed serum concentration at the end of a dosing interval (CTAU) [Approximately 5 years]
Part 1 and Part 2
- Trough observed serum concentration at the end of the dosing interval (CTROUGH) [Approximately 5 years]
Part 1 and Part 2
- 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)
- Overall Survival (OS) [Approximately 5 years]
Part 2
- 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 death [Approximately 5 years]
Part 2
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution | Springdale | Arkansas | United States | 72762 |
2 | Local Institution | Aurora | Colorado | United States | 80045 |
3 | Rocky Mountain Cancer Centers | Denver | Colorado | United States | 80218 |
4 | Local Institution | Miami Beach | Florida | United States | 33140 |
5 | Local Institution | Atlanta | Georgia | United States | 30322 |
6 | Maryland Oncology Hematology P.A. | Columbia | Maryland | United States | 21044 |
7 | Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Lutherville | Maryland | United States | 21093 |
8 | University Of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
9 | Local Institution | Omaha | Nebraska | United States | 68130 |
10 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
11 | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
12 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08901 |
13 | Icahn School Of Medicine At Mount Sinai | New York | New York | United States | 10029 |
14 | Columbia University Medical Center (Cumc) | New York | New York | United States | 10032 |
15 | Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
16 | Willamette Valley Cancer Institute And Research Center | Eugene | Oregon | United States | 97401 |
17 | Local Institution | Philadelphia | Pennsylvania | United States | 19111 |
18 | UPMC Cancer Center | Pittsburgh | Pennsylvania | United States | 15213 |
19 | Greenville Health System | Greenville | South Carolina | United States | 29605 |
20 | Texas Oncology-Austin Midtown | Austin | Texas | United States | 78705 |
21 | Texas Oncology - Baylor Charles A. Simmons Cancer Center | Dallas | Texas | United States | 75246 |
22 | Local Institution | Fort Worth | Texas | United States | 76104-3927 |
23 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
24 | Texas Oncology-San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
25 | Texas Oncology - DFWW | Tyler | Texas | United States | 75702 |
26 | Local Institution | Salt Lake City | Utah | United States | 84112 |
27 | Virginia Cancer Specialists, PC | Fairfax | Virginia | United States | 22031 |
28 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
29 | Local Institution | Richmond | Virginia | United States | 23298 |
30 | Local Institution | Wollstonecraft | New South Wales | Australia | 2065 |
31 | Local Institution | Adelaide | South Australia | Australia | 5000 |
32 | Local Institution | Ballarat Central | Victoria | Australia | 3350 |
33 | Local Institution | Epping | Victoria | Australia | 3076 |
34 | Local Institution - 0095 | Melbourne | Victoria | Australia | 3004 |
35 | Local Institution | Nedlands | Western Australia | Australia | 6009 |
36 | Local Institution | Bruxelles | Belgium | 1200 | |
37 | Local Institution - 0036 | Gent | Belgium | 9000 | |
38 | Local Institution | Edmonton | Alberta | Canada | T6G 1Z2 |
39 | Local Institution - 0029 | Vancouver | British Columbia | Canada | V5Z 4E6 |
40 | Local Institution | Victoria | British Columbia | Canada | V8R 6V5 |
41 | Local Institution | Toronto | Ontario | Canada | M5G 1Z5 |
42 | Local Institution | Toronto | Ontario | Canada | M5G 2M9 |
43 | Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies | Montréal | Canada | H2X 3E4 | |
44 | Local Institution - 0067 | Marseille | France | 13385 | |
45 | Local Institution - 0085 | Nantes | France | 44000 | |
46 | Local Institution - 0068 | Paris | France | 75010 | |
47 | Local Institution | Villejuif | France | 94800 | |
48 | Local Institution | Berlin | Germany | 12203 | |
49 | Local Institution | Gerlingen | Germany | 70839 | |
50 | Local Institution | Hamburg | Germany | 20246 | |
51 | Local Institution | Hamburg | Germany | 20251 | |
52 | Local Institution | Mainz | Germany | 55131 | |
53 | Local Institution | Mainz | Germany | 55131 | |
54 | Local Institution | Tuebingen | Germany | 72076 | |
55 | IRST Meldola | Forlì | Italy | 47014 | |
56 | Local Institution - 0042 | Milano | Italy | 20132 | |
57 | Istituto Nazionale Tumori Fondazione Pascale | Napoli | Italy | 80131 | |
58 | Local Institution | Rozzano-milano | Italy | 20089 | |
59 | Local Institution | Krakow | Poland | 31-115 | |
60 | Local Institution | Warszawa | Poland | 02-781 | |
61 | Local Institution - 0045 | Madrid | Spain | 28034 | |
62 | Local Institution - 0022 | Madrid | Spain | 28040 | |
63 | Local Institution - 0023 | Madrid | Spain | 28050 | |
64 | Hospital Universitario Virgen De La Victoria | Malaga | Spain | 29010 | |
65 | Local Institution - 0021 | Pamplona | Spain | 31008 | |
66 | Hospital Clinico Univ. de Santiago-CHUS | Santiago Compostela | Spain | 15706 | |
67 | Chu Vaudois Lausanne | Lausanne | Switzerland | 1011 | |
68 | Kantonsspital St. Gallen | St.Gallen | Switzerland | 9007 | |
69 | University Hospital Zuerich | Zuerich | Switzerland | 8091 | |
70 | Local Institution - 0024 | Manchester | Greater Manchester | United Kingdom | M20 4BX |
71 | Local Institution | Birmingham | West Midlands | United Kingdom | B15 2TH |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA027-002
- 2018-000340-26