Clinical trial NCT03369223: A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Official title: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: Antibodies
Antineoplastic Agents
Immunologic Factors
Nivolumab
Antibodies, Monoclonal
Physiological Effects of Drugs
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 607
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 determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 2.5 years
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 2.5 years
measure: Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to 2.5 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 2.5 years
measure: Incidence of death
timeFrame: Up to 4 years
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 2.5 years
measure: Incidence of treatment-related Grade 3-5 AEs
timeFrame: Within 24 weeks
measure: Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 2.5 years
Secondary outcomes:
measure: Cmax (Maximum observed serum concentration)
timeFrame: Up to 2 years
measure: Tmax (Time of maximum observed concentration)
timeFrame: Up to 2 years
measure: AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration)
timeFrame: Up to 2 years
measure: ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer)
timeFrame: Up to 4 years
measure: Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
timeFrame: Up to 4 years
measure: Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
timeFrame: Up to 4 years
measure: Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
timeFrame: Up to 4 years
measure: Incidence of AEs in Part 2 of Study
timeFrame: Up to 2.5 years
measure: Incidence of SAEs in Part 2 of Study
timeFrame: Up to 2.5 years
measure: Incidence of AEs leading to discontinuation in Part 2 of study
timeFrame: Up to 2.5 years
measure: Incidence of death in Part 2 of study
timeFrame: Up to 4 years
measure: Number of participants with clinical laboratory abnormalities Part 2 of study
timeFrame: Up to 2.5 years
measure: Time to Deterioration (TTD) in Part 2 of study
timeFrame: Up to 4 Years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Local Institution - 0005
state: Colorado
city: Denver
country: United States
facility: Local Institution - 0006
state: Colorado
city: Miami
country: United States
facility: Local Institution - 0017
state: Florida
city: Baltimore
country: United States
facility: Local Institution - 0024
state: Maryland
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0002
state: New York
city: New York
country: United States
facility: Local Institution - 0003
state: New York
city: Cincinnati
country: United States
facility: Local Institution - 0029
state: Ohio
city: Eugene
country: United States
facility: Local Institution - 0013
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 0004
state: Pennsylvania
city: Greenville
country: United States
facility: Local Institution - 0008
state: South Carolina
city: Austin
country: United States
facility: Local Institution - 0010
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0009
state: Texas
city: Houston
country: United States
facility: Local Institution - 0021
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0016
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0011
state: Texas
city: Leesburg
country: United States
facility: Local Institution - 0012
state: Virginia
city: Norfolk
country: United States
facility: Local Institution - 0007
state: Virginia
city: Vancouver
country: United States
facility: Local Institution - 0018
state: Washington
city: Buenos Aires
country: Argentina
facility: Local Institution - 0038
state: Distrito Federal
city: Caba
country: Argentina
facility: Local Institution - 0052
state: Distrito Federal
city: Buenos Aires
country: Argentina
facility: Local Institution - 0037
city: North Sydney
country: Australia
facility: Local Institution - 0015
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution - 0014
state: South Australia
city: Frankston
country: Australia
facility: Local Institution - 0025
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0047
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution - 0026
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution - 0056
state: Ontario
city: Santiago
country: Chile
facility: Local Institution - 0036
state: Metropolitana
city: Helsinki
country: Finland
facility: Local Institution - 0039
city: Essen
country: Germany
facility: Local Institution - 0030
city: Hamburg
country: Germany
facility: Local Institution - 0035
city: Heidelberg
country: Germany
facility: Local Institution - 0031
city: Milan
country: Italy
facility: Local Institution - 0048
city: Napoli
country: Italy
facility: Local Institution - 0020
city: Siena
country: Italy
facility: Local Institution - 0049
city: Warszawa
country: Poland
facility: Local Institution - 0040
city: Bucharest
country: Romania
facility: Local Institution - 0045
city: Craiova
country: Romania
facility: Local Institution - 0041
city: Badalona
country: Spain
facility: Local Institution - 0042
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Local Institution - 0022
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Local Institution - 0044
city: Madrid
country: Spain
facility: Local Institution - 0023
city: Madrid
country: Spain
facility: Local Institution - 0050
city: Malaga
country: Spain
facility: Local Institution - 0043
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: