Clinical trial NCT03978611: A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment
Official title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.


Eligibility criteria: Inclusion Criteria:

* Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab
* Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
* Eastern Cooperative Oncology Group (ECOG) 0-1

Exclusion Criteria:

* History of uveal melanoma
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
* Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
measure: Number of Participants With Adverse Events Including Dose Limiting Toxicity
timeFrame: Up to 28 days after last study drug dose (approximately up to 2 years)
measure: Number of Participants with AEs resulting in Discontinuation
timeFrame: Up to end of study (approximately 2.4 years)
measure: Number of Participants with AEs resulting in Death
timeFrame: Up to end of study (approximately 2.4 years)
measure: Number of Participants with AEs resulting in Laboratory Abnormalities
timeFrame: Up to end of study (approximately 2.4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0023
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0002
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0005
state: California
city: Santa Monica
country: United States
facility: Local Institution - 0001
state: California
city: Miami
country: United States
facility: Local Institution - 0015
state: Florida
city: Chicago
country: United States
facility: Local Institution - 0004
state: Illinois
city: Ann Arbor
country: United States
facility: Local Institution - 0003
state: Michigan
city: Morristown
country: United States
facility: Local Institution - 0008
state: New Jersey
city: Bruxelles
country: Belgium
facility: Local Institution - 0018
state: Brussels
city: Antwerpen
country: Belgium
facility: Local Institution - 0017
city: Brussels
country: Belgium
facility: Local Institution - 0016
city: Bruxelles
country: Belgium
facility: Local Institution - 0038
city: Ottawa
country: Canada
facility: Local Institution - 0044
state: Ontario
city: Erlangen
country: Germany
facility: Local Institution - 0037
city: Essen
country: Germany
facility: Local Institution - 0034
city: Gera
country: Germany
facility: Local Institution - 0036
city: Hannover
country: Germany
facility: Local Institution - 0035
city: Heidelberg
country: Germany
facility: Local Institution - 0033
city: Lübeck
country: Germany
facility: Local Institution - 0032
city: Nuremberg
country: Germany
facility: Local Institution - 0040
city: Padova
country: Italy
facility: Local Institution - 0053
city: Siena
country: Italy
facility: Local Institution - 0055
city: Barcelona
country: Spain
facility: Local Institution - 0026
city: Cordoba
country: Spain
facility: Local Institution - 0030
city: Hospitalet de Llobregat - Barcelona
country: Spain
facility: Local Institution - 0027
city: Madrid
country: Spain
facility: Local Institution - 0029
city: San Sebastian
country: Spain
facility: Local Institution - 0031
city: Valencia
country: Spain
facility: Local Institution - 0028
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: