NYU Langone Health
The purpose of this study is to investigate the use of ctDNA measurements to guide first-lien therapy choice for patients with advanced or metastatic melanoma. Primary endpoints include progression-free survival. Secondary study endpoints include objective response rate and incidence and severity of immune-related adverse events.
This study's approach seeks to rationally, rather than empirically, choose one treatment approach over another, as well as to develop methods to predict disease recurrence at earlier time points. The combination of ipilimumab and nivolumab is the standard of care for first-line treatment of advanced melanoma. This study instead seeks to pioneer treatment choice based on evidence of molecular relapse, and to determine whether this results in superior outcomes compared with the current standard of care to treat until evidence of radiologic progression. Patients with sustained "zeroconversion" ma…
Inclusion Criteria: 1. Patient must be ≥ 18 years old. 2. Patients must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent from (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care. 3. Patients must be willing and able to comply with scheduled visits, laboratory tests, and other requirements of the study. 4. Patient must have active advanced melanoma, defined as unresectable stage IIIB-…
480 mg Nivolumab every 4 weeks
160 mg Relatlimab every 4 weeks
50 mg (1 mg/kg) intravenously every 8 weeks
SignateraTM is a personalized, tumor-informed circulating tumor DNA (ctDNA)-based test of molecular residual disease (MRD). The Signatera Designed on Genome test is a qualitative and quantitative test that reports the presence or absence of ctDNA as "ctDNA Positive" or "ctDNA Not Detected".
Arctuva estimate
Verify or correct the compensation shown for this listing.