Clinical trial NCT03459222: An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
Official title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: Immunotherapy
Relatlimab
Nivolumab
Ipilimumab
BMS-986205
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 229
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 demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
* Available tumor tissue for biomarker analysis
* Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1

Exclusion Criteria:

* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
* History of interstitial lung disease / pneumonitis
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of clinical laboratory test abnormalities
timeFrame: Approximately 4 years
measure: Number of Adverse Events (AEs)
timeFrame: Approximately 4 years
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Approximately 4 years
measure: Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to 6 weeks
measure: Number of AEs leading to discontinuation
timeFrame: Approximately 4 years
measure: Number of AEs leading to death
timeFrame: Approximately 4 years
measure: Objective Response Rate (ORR)
timeFrame: Approximately 4 years
measure: Disease Control Rate (DCR)
timeFrame: Approximately 4 years
measure: Median Duration of Response (mDOR)
timeFrame: Approximately 4 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Local Institution - 0006
state: California
city: Aurora
country: United States
facility: Local Institution - 0003
state: Colorado
city: Baltimore
country: United States
facility: Local Institution - 0004
state: Maryland
city: Saint Louis
country: United States
facility: Local Institution - 0005
state: Missouri
city: Germantown
country: United States
facility: Local Institution - 0001
state: Tennessee
city: Wollstonecraft
country: Australia
facility: Local Institution - 0012
state: New South Wales
city: Nedlands
country: Australia
facility: Local Institution - 0011
state: Western Australia
city: Marseille Cedex 5
country: France
facility: Local Institution - 0017
city: Toulouse Cedex 9
country: France
facility: Local Institution - 0016
city: Villejuif
country: France
facility: Local Institution - 0015
city: Forlì
country: Italy
facility: Local Institution - 0010
city: Napoli
country: Italy
facility: Local Institution - 0009
city: Rome
country: Italy
facility: Local Institution - 0023
city: Barcelona
country: Spain
facility: Local Institution - 0019
city: Madrid
country: Spain
facility: Local Institution - 0021
city: Madrid
country: Spain
facility: Local Institution - 0018
city: Málaga
country: Spain
facility: Local Institution - 0022
city: Pamplona
country: Spain
facility: Local Institution - 0020
city: Lausanne
country: Switzerland
facility: Local Institution - 0008
city: Zuerich
country: Switzerland
facility: Local Institution - 0007
city: Headington
country: United Kingdom
facility: Local Institution - 0013
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution - 0014
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: