The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Specified dose on specified days
Local Institution - 0009
Navi Mumbai, Maharashtra, India
Local Institution - 0008
Pune, Maharashtra, India
Local Institution - 0003
Bhubaneswar, Odisha, India
Local Institution - 0002
Chennai, India
Incidence of adverse events (AEs)
Time frame: Up to 30 weeks
Incidence of drug-related AEs
Time frame: Up to 30 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 30 weeks
Incidence of drug-related SAEs
Time frame: Up to 30 weeks
Incidence of immune-mediated adverse events (IMAEs)
Time frame: Up to 30 weeks
AEs leading to discontinuation of treatment
Time frame: Up to 30 weeks
Number of deaths
Time frame: Up to 30 weeks
Number of participants with laboratory abnormalities
Time frame: Up to 30 weeks
Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 30 weeks
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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CONTACT
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Local Institution - 0006
Mumbai, India
Local Institution - 0005
Nagpur, India
Local Institution - 0004
New Delhi, India
Local Institution - 0001
New Delhi, India