Clinical trial NCT03994601: An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Official title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-06-21
Enrollment: 219
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-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Exclusion Criteria:

* Active, known or suspected autoimmune disease
* Active malignancy requiring concurrent intervention
* Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 2 years
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 2 years
measure: Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria
timeFrame: Up to 2 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 2 years
measure: Incidence of AEs leading to death
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review
timeFrame: Up to 2 years
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of BMS-986288
timeFrame: Up to 2 years
measure: Time of Maximum Observed Concentration (Tmax) of BMS-986288
timeFrame: Up to 2 years
measure: Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
timeFrame: Up to 2 years
measure: Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
timeFrame: Up to 2 years
measure: Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288
timeFrame: Up to 2 years
measure: Trough Observed Concentrations (Ctrough) of BMS-986288
timeFrame: Up to 2 years
measure: Total Body Clearance (CLT) of BMS-986288
timeFrame: Up to 4 months
measure: Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288
timeFrame: Up to 4 months
measure: Accumulation Index (AI) of BMS-986288
timeFrame: Up to 4 months
measure: Terminal Half-Life (T-HALF) of BMS-986288
timeFrame: Up to 4 months
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
timeFrame: Up to 4 years
measure: Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment
timeFrame: Up to 4 years
measure: Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment
timeFrame: Up to 4 years
measure: Time to Response (TTR) by RECIST v1.1 by Investigator Assessment
timeFrame: Up to 4 years
measure: DOR by RECIST v1.1 by blinded independent central review
timeFrame: Up to 4 years
measure: PFS by RECIST v1.1 by blinded independent central review
timeFrame: Up to 4 years
measure: Overall Survival (OS) by RECIST v1.1 by blinded independent central review
timeFrame: Up to 4 years
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 100 days following last dose of study treatment
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 100 days following last dose of study treatment
measure: Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria
timeFrame: Up to 100 days following last dose of study treatment
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 100 days following last dose of study treatment
measure: Incidence of AEs leading to death
timeFrame: Up to 100 days following last dose of study treatment
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Local Institution - 0075
state: California
city: Orange
country: United States
facility: Local Institution - 0050
state: California
city: Aurora
country: United States
facility: Local Institution - 0005
state: Colorado
city: Baltimore
country: United States
facility: Local Institution - 0002
state: Maryland
city: Saint Louis
country: United States
facility: Local Institution - 0004
state: Missouri
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Local Institution - 0011
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0074
state: Ciudad Autónoma De Buenos Aires
city: Córdoba
country: Argentina
facility: Local Institution - 0014
state: Cordoba
city: Río Cuarto
country: Argentina
facility: Local Institution - 0013
state: Cordoba
city: ABB
country: Argentina
facility: Local Institution - 0008
state: Distrito Federal
city: Caba
country: Argentina
facility: Local Institution - 0012
state: Distrito Federal
city: Buenos Aires
country: Argentina
facility: Local Institution - 0017
city: Buenos Aires
country: Argentina
facility: Local Institution - 0016
city: Toronto
country: Canada
facility: Local Institution - 0006
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0046
state: Quebec
city: Montréal
country: Canada
facility: Local Institution - 0042
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0019
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0035
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0009
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0036
state: Región Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Local Institution - 0010
state: Valparaiso
city: Bordeaux
country: France
facility: Local Institution - 0034
state: Gironde
city: Saint-Herblain
country: France
facility: Local Institution - 0022
state: Loire-Atlantique
city: Bron Cedex
country: France
facility: Local Institution - 0018
city: Marseille
country: France
facility: Local Institution - 0026
city: Paris
country: France
facility: Local Institution - 0015
city: Toulon
country: France
facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
city: Milan
country: Italy
facility: Local Institution - 0040
state: Lombardia
city: Padova
country: Italy
facility: Local Institution - 0038
state: Veneto
city: Ancona
country: Italy
facility: Local Institution - 0028
city: Catanzaro
country: Italy
facility: Local Institution - 0033
city: Milan
country: Italy
facility: Local Institution - 0031
city: Roma
country: Italy
facility: Local Institution - 0039
city: Barcelona
country: Spain
facility: Local Institution - 0056
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Local Institution - 0054
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Local Institution - 0023
city: Majadahonda
country: Spain
facility: Local Institution - 0024
city: Sevilla
country: Spain
facility: Local Institution - 0055
city: València
country: Spain
facility: Local Institution - 0025
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: