A Phase II Study of LXH254 in Combination with Other Drugs in People with Previously Treated Inoperable or Metastatic Melanoma

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Full Title

A Randomized, Open-Label, Multi-Arm, Two-Part, Phase II Study to Assess The Efficacy And Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

Purpose

The purpose of this study is to assess whether the investigational drug LXH254 given in combination with LTT462, trametinib, or ribociclib is an effective treatment for people with inoperable or metastatic melanoma containing a BRAF V600 or NRAS mutation. LXH254 targets cancer cells with these mutations and prevents them from taking in an energy source called ATP, causing the cells to die.

Patients in this study will be randomly assigned to receive LXH254 in combination with either LTT462, trametinib, or ribociclib.

  • LXH254 targets BRAF proteins and should help stop BRAF V600- and NRAS-mutant cancers from growing
  • LTT462 blocks proteins called ERK1/2, which cancer cells need to grow and survive.
  • Trametinib may cause cancer cells to die by blocking proteins called MEK.
  • Ribociclib blocks proteins called CDKs, which cells need to divide and grow.

All of these medications are taken orally (by mouth).

 

 

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic melanoma that continues to grow despite prior immunotherapy with a PD-1 blocker (pembrolizumab or nivolumab) or CTLA-4 blocker (ipilimumab).
  • At least 4 weeks must pass between completion of immunotherapy and receipt of the study medications.
  • Patients’ tumors must contain a BRAF V600 or NRAS mutation.
  • Patients with BRAF V600-mutant melanomas must have received BRAF and MEK inhibitors as the most recent treatment prior to this study, and the prior number of treatments must be no more than three.
  • Patients with NRAS-mutant melanomas must have received no more than two prior regimens of treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

20-526

Phase

II

Co-Investigators

Diseases