Clinical trial NCT04943900: A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
Official title: A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: BMS-986416
Nivolumab
Opdivo
Non-small cell lung cancer (NSCLC)
Urothelial carcinoma (UC)
Squamous cell carcinoma of the head and neck (SCCHN)
Hepatocellular carcinoma (HCC)
Microsatellite-stable colorectal carcinoma (MSS CRC)
Pancreatic ductal adenocarcinoma (PDAC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
* Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
* Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
* Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
* Disease amenable to serial biopsy

Exclusion Criteria:

* Uncontrolled or significant cardiovascular disease
* Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
* Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Incidence of AEs leading to death
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
timeFrame: Up to 100 days after the last treatment of study intervention(s)
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of BMS-986416
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Time of maximum observed serum concentration (Tmax) of BMS-986416
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Trough observed serum concentration (Ctrough) of BMS-986416
timeFrame: Up to 100 days after the last treatment of study intervention(s)
measure: Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment
timeFrame: Up to 2 years
measure: Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
timeFrame: Up to 2 years
measure: Incidence of clinically significant changes in ECG parameters: QTcF
timeFrame: Up to 100 days after the last treatment of study intervention(s)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Local Institution - 0006
state: Georgia
city: Baltimore
country: United States
facility: Local Institution - 0005
state: Maryland
city: Hackensack
country: United States
facility: Local Institution - 0002
state: New Jersey
city: Cleveland
country: United States
facility: Local Institution - 0013
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0003
state: Pennsylvania
city: Houston
country: United States
facility: Local Institution - 0004
state: Texas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0021
state: Buenos Aires
city: ABB
country: Argentina
facility: Local Institution - 0027
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Local Institution - 0022
state: Ciudad Autónoma De Buenos Aires
city: Edegem
country: Belgium
facility: Local Institution - 0043
state: Antwerpen
city: Gent
country: Belgium
facility: Local Institution - 0016
state: Oost-Vlaanderen
city: Edmonton
country: Canada
facility: Local Institution - 0009
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 0008
state: Ontario
city: Montréal
country: Canada
facility: Local Institution - 0001
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0026
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0025
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0024
state: Región Metropolitana De Santiago
city: Chuo-ku
country: Japan
facility: Local Institution - 0010
state: Tokyo
city: Maastricht
country: Netherlands
facility: Local Institution - 0020
state: Limburg
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: