Full Title
A Randomized, Open-Label Phase 3 Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination Of Naporafenib + Trametinib to Physician’s Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization Lead-in (SEACRAFT-2)Purpose
Researchers want to see how well the drugs naporafenib and trametinib work when given together to treat melanoma. The people in this study have melanoma of the skin that has spread or cannot be removed with surgery (inoperable). In addition, their cancers have a mutation (change) in the NRAS gene. Naporafenib and trametinib each work by blocking proteins melanoma needs to grow.
The researchers will assess different doses of naporafenib and trametinib to learn which one works best. They will then see if this two-drug combination works as well as standard treatments for NRAS-mutated cutaneous melanoma. The standard treatments include dacarbazine, temozolomide, and trametinib alone.
Who Can Join
To join this study, there are a few conditions. You must:
- Have NRAS-mutated melanoma of the skin (cutaneous melanoma) that has spread or is inoperable.
- Have melanoma that keeps growing even after immunotherapy.
- Have recovered from the serious side effects of prior therapies before getting the study treatment.
- Be able to walk and do routine activities for more than half the time you are awake.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Parisa Momtaz’s office at 914-367-7346.