Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (NCT04417621)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight \> 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma Previously treated for unresectable or metastatic melanoma:
2. Participants with NRAS mutation:
3. Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents.
4. A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents administered with CPI are permitted.
5. To rule out pseudo-progression, participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. Confirmation is not required for patients who remained on treatment for \>6 months.
6. Participants with BRAFV600 mutant disease:
7. Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI allowed) as the last prior therapy.
8. A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents with CPI are permitted.
9. A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy.
10. Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy. Other protocol-defined inclusion criteria may apply.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (36 Sites)

• The Angeles Clinic and Research Institute — Los Angeles, California
• UCSF Medical Center — San Francisco, California
• Florida Cancer Specialists — Fort Myers, Florida
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
• Massachusetts General Hospital — Boston, Massachusetts
• Dana Farber Cancer Institute — Boston, Massachusetts
• Mayo Clinic Mayo Rochester — Rochester, Minnesota
• Mayo Clinic Rochester — Rochester, Minnesota
• NYU Laura and Isaac Perlmutter Cancer Center — New York, New York
• Memorial Sloan Kettering — New York, New York
• University of Pittsburgh Med Center — Pittsburgh, Pennsylvania
• Univ of TX MD Anderson Cancer Cntr — Houston, Texas
• Novartis Investigative Site — CABA, Buenos Aires
• Novartis Investigative Site — North Sydney, New South Wales
• Novartis Investigative Site — Wooloongabba, Queensland
• Novartis Investigative Site — Subiaco, Western Australia
• Novartis Investigative Site — Leuven,
• Novartis Investigative Site — Wilrijk,
• Novartis Investigative Site — Lille,
• Novartis Investigative Site — Marseille,
• Novartis Investigative Site — Paris,
• Novartis Investigative Site — Pierre-Bénite,
• Novartis Investigative Site — Toulouse,
• Novartis Investigative Site — Villejuif,
• Novartis Investigative Site — Dresden, Saxony

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.