Clinical trial NCT03956680: An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
Official title: A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Cancers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* Must have experienced radiographically documented progressive disease on or after the most recent therapy
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Primary central nervous system (CNS) malignancy
* 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 toxicity (DLTs)
timeFrame: Cycle 1 (28 days)
measure: Incidence of adverse events (AEs)
timeFrame: From Baseline until study exit (up to approximately 2 years)
measure: Incidence of serious adverse events (SAEs)
timeFrame: From Baseline until study exit (up to approximately 2 years)
measure: Incidence of AEs leading to discontinuation
timeFrame: From Baseline until study exit (up to approximately 2 years)
measure: Incidence of deaths
timeFrame: From Baseline until study exit (up to approximately 2 years)
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: From Baseline until disease progression (approximately 2 years)
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: From Baseline until disease progression (approximately 2 years)
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: From Baseline until disease progression (approximately 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Local Institution - 0003
state: Illinois
city: Saint Louis
country: United States
facility: Local Institution - 0005
state: Missouri
city: Pittsburgh
country: United States
facility: Local Institution - 0006
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0002
state: Tennessee
city: Toronto
country: Canada
facility: Local Institution - 0001
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: