Summary

Eligibility
for people ages 12-120 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Adil Daud
Headshot of Adil Daud
Adil Daud

Description

Summary

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

Official Title

A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

Keywords

Melanoma LXH254 NRAS BRAF LTT462 Trametinib Ribocliclib Ribociclib LXH254 + LTT462 LXH254 + trametinib LXH254 + ribociclib

Eligibility

You can join if…

Open to people ages 12-120

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 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.

You CAN'T join if...

Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:

  • ≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
  • ≤ 2 weeks for small molecule therapeutics.
  • ≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
  • ≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents.
  • ≤ 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

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • The Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States

Lead Scientist at UCSF

  • Adil Daud
    Professor, Medicine, School of Medicine. Authored (or co-authored) 188 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04417621
Phase
Phase 2 research study
Study Type
Interventional
Last Updated