A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Nivolumab + Relatlimab
- drug: rHuPH20
Eligibility
Inclusion Criteria
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status
of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging
system.
- Participants must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and <
18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed
consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the AJCC staging system (8th edition).
Exclusion Criteria
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either
corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other
immunosuppressive medications within 14 days of start of study treatment. Inhaled or
topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone
equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Phuong Q Pham
650-725-9810
I'm interested
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.