This study is currently not recruiting participants.

A multicentre open label randomized Phase II trial of the MEK inhibitor pimasertib or dacarbazine in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma

Phase 2 Study: Investigating Treatment Options for N-Ras Mutated Melanoma

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

Detailed description of study

This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Melanoma
  • Age: 18 years - 100 years
  • Gender: All

This study investigates treatment options for people with N-Ras mutated melanoma, a type of skin cancer that can spread to other parts of the body. The purpose is to compare how well two treatments work in stopping the cancer from growing. One treatment involves an investigational medication, while the other uses a standard treatment.

Participants will be assigned to one of two study arms. In one arm, participants will receive the investigational medication, and in the other arm, they will receive the standard treatment. The study will also look at the safety of the treatments and how they interact with participants' genes.

  • Who can participate: Individuals aged 18 and older with N-Ras mutated locally advanced or metastatic melanoma who have not received prior treatment.
  • Study details: Participants will receive either the investigational medication or the standard treatment. The study will also monitor the safety of the treatments and their effects on genetic markers.
Updated on 19 Feb 2024. Study ID: 1302010694

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