Melanoma Clinical Trial
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma
Male or female must be â‰¥ 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:
Participants with NRAS mutation:
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.
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.
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.
Participants with BRAFV600 mutant disease:
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.
A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents with CPI are permitted.
A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy.
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.
Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
â‰¤ 4 weeks for radiation therapy or â‰¤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
â‰¤ 2 weeks for small molecule therapeutics.
â‰¤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
â‰¤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents.
â‰¤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c.
Participants participating in additional parallel investigational drug or medical device studies.
All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Other protocol-defined exclusion criteria may apply
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There are 35 Locations for this study
Los Angeles California, 90025, United States
San Francisco California, 94143, United States
Fort Myers Florida, 33901, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
New York New York, 10016, United States
New York New York, 10017, United States
Pittsburgh Pennsylvania, 15213, United States
Houston Texas, 77030, United States
Caba Buenos Aires, C1426, Argentina
North Sydney New South Wales, 2060, Australia
Wooloongabba Queensland, 4102, Australia
Subiaco Western Australia, 6008, Australia
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Lille Cedex , 59037, France
Marseille Cedex 05 , 13885, France
Paris Cedex 10 , 75475, France
Pierre Benite , 69495, France
Toulouse , 31059, France
Villejuif Cedex , 94800, France
Dresden , 01307, Germany
Essen , 45147, Germany
Heidelberg , 69120, Germany
Tuebingen , 72076, Germany
Ramat Gan , 52621, Israel
Milano MI, 20133, Italy
Napoli , 80131, Italy
Maastricht , 6229 , Netherlands
Oslo , 0379, Norway
Lausanne , 1011, Switzerland
Zuerich , 8091, Switzerland
Manchester , M20 2, United Kingdom
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