ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
Patient must be ≥ 18 years old.
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.
Patients must be willing and able to comply with scheduled visits, laboratory tests, and other requirements of the study.
Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients with mucosal melanoma defined as unresectable stage III or regional/distant metastatic disease are eligible.
Disqualifiers
Patients with carcinomatosis meningitis or a history of current ocular/uveal melanoma are excluded.
Patients with a history of myocarditis.
Patients with active, known, or suspected autoimmune disease requiring immunosuppression beyond 10 mg daily of prednisone. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent.
Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of C1D1. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Trial design
Treatments tested in this trial
- Nivolumab
- Relatlimab
- Ipilimumab
- Signatera genome MRD assay
Treatment groups
90 Participants
are divided into 4 treatment groupsLocations
1NYU Langone Health10016, New YorkNew York, United States
Sponsors and collaborators
NYU Langone Health
Lead sponsor
Source ClinicalTrials.gov