Clinical trial NCT03444753: An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
Official title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* IO therapy resistant or insensitive tumors
* Have at least 2 tumor lesions accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

* Primary CNS malignancy
* Participants with other active malignancy requiring concurrent intervention
* Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: Up to 28 days
measure: Incidence of adverse events (AEs)
timeFrame: Approximately 2 years
measure: Incidence of clinical laboratory abnormalities
timeFrame: Approximately 2 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Approximately 2 years
measure: Incidence of AEs leading to discontinuation and deaths
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Approximately 2 years
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Approximately 2 years
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Approximately 2 years
measure: Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Local Institution - 0003
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: