Clinical trial NCT03400332: A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Official title: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cancer
Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of adverse events (AE)
timeFrame: Approximately 5 years
measure: Incidence of serious adverse events (SAE)
timeFrame: Approximately 5 years
measure: Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
timeFrame: Approximately 5 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Approximately 5 years
measure: Incidence of deaths
timeFrame: Approximately 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Approximately 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Approximately 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Approximately 5 years
measure: ORR based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized patients
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator
timeFrame: Approximately 5 years
measure: Duration of response (DOR) per response evaluation criteria in solid tumors (RECIST) v1.1 per investigator
timeFrame: Approximately 5 years
measure: Incidence of anti-drug antibody (ADA) to BMS-986253
timeFrame: Approximately 5 years
measure: Serum biomarker concentration
timeFrame: Approximately 5 years
measure: Maximum observed serum concentration (Cmax)
timeFrame: Approximately 5 years
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Approximately 5 years
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Approximately 5 years
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
timeFrame: Approximately 5 years
measure: Observed serum concentration at the end of a dosing interval (CTAU)
timeFrame: Approximately 5 years
measure: Trough observed serum concentration at the end of the dosing interval (CTROUGH)
timeFrame: Approximately 5 years
measure: Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Approximately 5 years
measure: Incidence of AEs
timeFrame: Approximately 5 years
measure: Incidence of SAEs
timeFrame: Approximately 5 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Approximately 5 years
measure: Incidence of death
timeFrame: Approximately 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Approximately 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Approximately 5 years
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Local Institution - 0059
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution - 0099
state: California
city: Lakewood
country: United States
facility: Local Institution - 0007
state: Colorado
city: Atlanta
country: United States
facility: Local Institution - 0087
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0100
state: Georgia
city: Marietta
country: United States
facility: Local Institution - 0101
state: Georgia
city: Columbia
country: United States
facility: Local Institution - 0012
state: Maryland
city: Lutherville
country: United States
facility: Local Institution - 0003
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0060
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 0004
state: Michigan
city: Omaha
country: United States
facility: Local Institution - 0076
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers Of Nevada
state: Nevada
city: Hackensack
country: United States
facility: Local Institution - 0005
state: New Jersey
city: New Brunswick
country: United States
facility: Local Institution - 0032
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0025
state: New York
city: New York
country: United States
facility: Local Institution - 0002
state: New York
city: Oklahoma City
country: United States
facility: Local Institution - 0028
state: Oklahoma
city: Eugene
country: United States
facility: Local Institution - 0017
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 0001
state: Pennsylvania
city: Greenville
country: United States
facility: Local Institution - 0009
state: South Carolina
city: Austin
country: United States
facility: Local Institution - 0011
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0010
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 0014
state: Texas
city: Houston
country: United States
facility: Local Institution - 0018
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0006
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0013
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution - 0058
state: Utah
city: Fairfax
country: United States
facility: Local Institution - 0015
state: Virginia
city: Norfolk
country: United States
facility: Local Institution - 0008
state: Virginia
city: Wollstonecraft
country: Australia
facility: Local Institution - 0088
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution - 0096
state: South Australia
city: Melbourne
country: Australia
facility: Local Institution - 0090
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0095
state: Victoria
city: Perth
country: Australia
facility: Local Institution - 0097
state: Western Australia
city: Ballarat Central
country: Australia
facility: Local Institution - 0091
city: Bruxelles
country: Belgium
facility: Local Institution - 0037
city: Gent
country: Belgium
facility: Local Institution - 0036
city: Kortrijk
country: Belgium
facility: Local Institution - 0082
city: Edmonton
country: Canada
facility: Local Institution - 0030
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0029
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution - 0078
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0020
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0055
state: Ontario
city: Montréal
country: Canada
facility: Local Institution - 0056
state: Quebec
city: Marseille
country: France
facility: Local Institution - 0067
state: Bouches-du-Rhône
city: Nantes
country: France
facility: Local Institution - 0085
city: Paris
country: France
facility: Local Institution - 0068
city: Toulouse
country: France
facility: Local Institution - 0102
city: Villejuif
country: France
facility: Local Institution - 0069
city: Tübingen
country: Germany
facility: Local Institution - 0054
state: Baden-Württemberg
city: Mainz
country: Germany
facility: Local Institution - 0052
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Local Institution - 0034
city: Hamburg
country: Germany
facility: Local Institution - 0053
city: Forlì
country: Italy
facility: Local Institution - 0043
city: Milano
country: Italy
facility: Local Institution - 0042
city: Napoli
country: Italy
facility: Local Institution - 0027
city: Rozzano-milano
country: Italy
facility: Local Institution - 0026
city: Krakow
country: Poland
facility: Local Institution - 0071
city: Warszawa
country: Poland
facility: Local Institution - 0077
city: Madrid
country: Spain
facility: Local Institution - 0045
city: Madrid
country: Spain
facility: Local Institution - 0022
city: Madrid
country: Spain
facility: Local Institution - 0023
city: Malaga
country: Spain
facility: Local Institution - 0044
city: Pamplona
country: Spain
facility: Local Institution - 0021
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0047
city: Lund
country: Sweden
facility: Local Institution - 0049
city: Lausanne
country: Switzerland
facility: Local Institution - 0040
city: St.Gallen
country: Switzerland
facility: Local Institution - 0041
city: Zuerich
country: Switzerland
facility: Local Institution - 0039
city: Manchester
country: United Kingdom
facility: Local Institution - 0024
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Local Institution - 0083
state: Lanarkshire
city: Birmingham
country: United Kingdom
facility: Local Institution - 0019
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: