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

  • STATUS
    Recruiting
  • End date
    Apr 27, 2023
  • participants needed
    320
  • sponsor
    Novartis Pharmaceuticals
Updated on 27 July 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (7.4 mi away) Contact
+33 other location
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, skin cancer, Metastatic Melanoma, Malignant Melanoma
Treatment Ribociclib, Trametinib, LXH254, LTT462
Clinical Study IdentifierNCT04417621
SponsorNovartis Pharmaceuticals
Last Modified on27 July 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 an anti-PD-1/PD-L1 checkpoint inhibitor as a single agent or in combination with anti-CTLA-4. No additional systemic treatment is allowed for unresectable or metastatic melanoma
A maximum of two prior lines of systemic immunotherapy for unresectable or metastatic melanoma are allowed
The last dose of prior therapy (anti-PD-1, anti-PD-L1 or anti-CTLA-4) must have been received more than four weeks before randomization
Participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. The last progression must have occurred within 12 weeks prior to randomization in the study
Participants with BRAFV600 mutant disease
Participants must have received prior systemic therapy for unresectable or metastatic melanoma with anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi as the last prior therapy. No additional systemic treatment is allowed for advanced or metastatic melanoma
A maximum of three prior lines of systemic therapy for unresectable or metastatic melanoma are allowed
The last dose of targeted therapy (last prior therapy) must have been received more than 2 weeks prior to randomization
Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy. The last progression must have occurred within 12 weeks prior to randomization in the study 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 or 5 half-life (whichever is shorter) for small molecule therapeutics
weeks for any immunotherapy treatment including immune checkpoint inhibitors
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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