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

  • STATUS
    Recruiting
  • End date
    Sep 8, 2023
  • participants needed
    320
  • sponsor
    Novartis Pharmaceuticals
Updated on 29 November 2021
metastatic melanoma
combinations
systemic therapy
NRAS
targeted therapy
trametinib
cytotoxic t-lymphocyte antigen 4
metastatic cutaneous melanoma

Summary

The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma

Details
Condition melanoma, Melanoma, skin cancer, Malignant Melanoma, Skin Cancer, Metastatic Melanoma
Treatment Ribociclib, Trametinib, LXH254, LTT462
Clinical Study IdentifierNCT04417621
SponsorNovartis Pharmaceuticals
Last Modified on29 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 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
Participants with BRAFV600 mutant disease
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

Exclusion Criteria

Treatment with any of the following anti-cancer therapies prior to the first
dose of study treatment within the stated timeframes
weeks for radiation therapy or 2 weeks for limited field radiation for palliation prior to the first dose of study treatment
weeks for small molecule therapeutics
weeks for any immunotherapy treatment including immune checkpoint inhibitors
weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents
Participants participating in additional parallel investigational drug or
weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c
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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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