Clinical trial NCT03446040: An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
Official title: A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 92
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-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.


Eligibility criteria: Inclusion Criteria:

* Histologic confirmation of one of the 5 tumors \[renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)\] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Participants 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 solid tumor histologies
* Women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Active, known or suspected autoimmune disease
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
* Other active malignancy requiring concurrent intervention

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Approximately 2 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Approximately 2 years
measure: Incidence of AEs leading to discontinuation
timeFrame: Approximately 2 years
measure: Incidence of AEs leading to death
timeFrame: Approximately 2 years
measure: Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 12 months
measure: Median duration of response (mDOR)
timeFrame: Up to 12 months
measure: Progression free survival (PFS) rate
timeFrame: Up to 12 months
measure: Maximum observed serum concentration (Cmax)
timeFrame: Approximately 2 years
measure: Time of maximum observed 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: Observed concentration at the end of a dosing interval (Ctau)
timeFrame: Approximately 2 years
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
timeFrame: Approximately 2 years
measure: Trough observed serum concentration at the end of the dosing interval (Ctrough)
timeFrame: Approximately 2 years
measure: Concentration at the end of infusion (Ceoi)
timeFrame: Approximately 2 years
measure: Incidence of anti-drug antibody (ADA) to BMS-986258
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0004
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0006
state: California
city: Aurora
country: United States
facility: Local Institution - 0007
state: Colorado
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Ann Arbor
country: United States
facility: Local Institution - 0018
state: Michigan
city: Grand Rapids
country: United States
facility: Local Institution - 0010
state: Michigan
city: Lebanon
country: United States
facility: Local Institution - 0012
state: New Hampshire
city: Cincinnati
country: United States
facility: Local Institution - 0016
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0005
state: Pennsylvania
city: Germantown
country: United States
facility: Local Institution - 0002
state: Tennessee
city: Westmead
country: Australia
facility: Local Institution - 0013
state: New South Wales
city: Melbourne
country: Australia
facility: Local Institution - 0015
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution - 0014
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0019
state: British Columbia
city: Kobe-shi
country: Japan
facility: Local Institution - 0009
state: Hyogo
city: Chuo-ku
country: Japan
facility: Local Institution - 0008
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12.