Clinical trial NCT05543629: A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
Official title: A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Non-small Cell Lung Cancer
Keywords: BMS-986442
Nivolumab
Chemotherapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.


Eligibility criteria: Inclusion Criteria:

* Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion Criteria:

* Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
* Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
* Participants with an active, known, or suspected autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
measure: Number of Participants With Serious Adverse Events
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
measure: Number of Participants With Dose Limiting Toxicities
timeFrame: From Cycle 1 day 1 to day 28 (28 Days)
measure: Number of Participants Who Died
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
Secondary outcomes:
measure: CMax
timeFrame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
measure: Tmax
timeFrame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
measure: AUC (Tau)
timeFrame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
measure: Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
measure: Objective Response Rate (ORR) Per Recist v1.1 by Investigator
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
measure: Disease Control Rate (DCR) Per Recist v1.1 by Investigator
timeFrame: From first dose to 100 days post last dose (Approximately 6 Months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix
state: Arizona
city: Costa Mesa
country: United States
facility: Local Institution - 0096
state: California
city: Orange
country: United States
facility: Local Institution - 0075
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0027
state: Florida
city: Fort Wayne
country: United States
facility: Local Institution - 0029
state: Indiana
city: New Orleans
country: United States
facility: Local Institution - 0022
state: Louisiana
city: Grand Rapids
country: United States
facility: Local Institution - 0005
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Hackensack
country: United States
facility: Local Institution - 0003
state: New Jersey
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0019
state: Ohio
city: Allentown
country: United States
facility: Local Institution - 0046
state: Pennsylvania
city: Houston
country: United States
facility: Local Institution - 0016
state: Texas
city: Darlinghurst
country: Australia
facility: Local Institution - 0018
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0001
state: New South Wales
city: Southport
country: Australia
facility: Local Institution - 0086
state: Queensland
city: Clayton
country: Australia
facility: Local Institution - 0002
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0084
state: Western Australia
city: Milan
country: Italy
facility: Local Institution - 0065
state: Milano
city: Candiolo
country: Italy
facility: Local Institution - 0064
state: Torino
city: Siena
country: Italy
facility: Local Institution - 0077
state: Toscana
city: Napoli
country: Italy
facility: Local Institution - 0062
city: Warszawa
country: Poland
facility: Local Institution - 0067
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Local Institution - 0073
state: Pomorskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0069
city: Barcelona
country: Spain
facility: Local Institution - 0080
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Local Institution - 0083
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0079
state: Madrid, Comunidad De
city: Málaga
country: Spain
facility: Local Institution - 0082
city: Sevilla
country: Spain
facility: Local Institution - 0087
city: València
country: Spain
facility: Local Institution - 0081
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: