A Phase II Study of LGX818 plus a Second Investigational Drug in Patients with Locally Advanced or Metastatic Melanoma that Continued to Grow on LGX818 Alone

Protocol
13-233
Full Title
A Phase II, Multi-center, Open-label Study of Single-agent LGX818 Followed by a Rational Combination with Targeted Agents after Progression on LGX818, to Overcome Resistance in Adult Patients with Locally Advanced or Metastatic BRAF V600 Melanoma (The LOGIC Trial)
Phase
II
Purpose

LGX818 is an investigational drug that blocks the activity of an abnormal form of a protein called BRAF, which promotes the growth of melanoma. This study is assessing LGX818 plus a second drug in patients whose melanoma has continued to grow while on LGX818 therapy alone. Patients will receive LGX818 with one of the following investigational anticancer drugs: MEK162, BGJ398, BKM120, INC280, or LEE011.

These other drugs work in the following ways:

  • MEK162 inhibits a protein called MEK1/2, which drives cancer growth.
  • BGJ398 works by inhibiting an enzyme involved in cancer growth called FGFR kinase.
  • BKM120 blocks a molecule called PI3 kinase, which appears to function abnormally in many cancers.
  • INC280 is designed to inhibit cancer growth by blocking the activity of an enzyme cancer cells need called “c-MET receptor tyrosine kinase.”
  • LEE011 blocks a protein called CDK, which tells melanoma cells to divide.

All of the drugs being assessed in this study 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 stage III melanoma or metastatic (stage IV) melanoma that is positive for the V600 BRAF mutation and has continued to grow despite therapy with LGX818.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Michael Postow at 646-888-4589.

Disease(s)
Melanoma
Locations
Related Diseases