Novel Clinical Trial for BRAFV600-Advanced Melanoma Initiates Patient Recruitment

Novel Clinical Trial for BRAFV600-Advanced Melanoma Initiates Patient Recruitment

The ECOG-ACRIN Cancer Research Group recently announced it will begin patient enrolment in its Phase III cancer clinical trial that will compare two differently acting treatments that have previously shown to be effective in the treatment of patients with advanced melanoma.

During the trial half of the melanoma patients will be randomised to start treatment with an investigational combination of two immunotherapy drugs. These two drugs activate the patient’s immune system to kill tumor cells. During the treatment, if the disease progresses or if the combination regimen stops working, patients will receive a different combination of two drugs known to block the molecular pathways that drive tumor cell survival and growth. The other half of the patients will be randomised to receive treatment with the two targeted drug agents and if the disease worsens and the drugs stop working, subjects will receive the combined immunotherapy regimen.

The EA6134 clinical trial aims to determine which regimen is better for patients’ clinical outcomes. “After many years of research we’ve ended up with exciting and effective new combination treatment regimens. Now we need to figure out how to sequence these treatment regimens in order to best extend the lives of our patient,” said study chair Michael B. Atkins, MD, a medical oncologist and deputy director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC.

“To be better, one sequence should significantly improve the number of patients alive at two and three years from the start of treatment when compared to the other sequence,” said Dr. Atkins.

Researchers intend to recruit 300 women and men aged over 18 years with a diagnosis of advanced melanoma and who carry a BRAFV600 mutation that cannot be removed by surgery because it has spread beyond its local area.

As Dr. Atkins explained: “We have an approved two-drug combination, dabrafenib and trametinib, which works by directly attacking BRAF-mutated melanomas. We also have two immunotherapy options, ipilimumab and nivolumab, each approved for separate use, that work in combination to unleash the body’s own immune system to attack the cancer. The question that remains is which of the two drug combinations should be used first and in whom?”

Because melanoma patients and their doctors have many treatment options to choose from, the trial offers the possibility to receive other therapeutic strategies, since researchers already know that for many patients melanoma can be highly aggressive and existing treatments often stop working.

Those involved in the trial will receive treatment with ipilimumab-nivolumab for up to two years and dabrafenib-trametinib will be administered for as long as it can control patients’ tumors.

After the study is closed, patients will be followed-up by their doctors to evaluate potential adverse side effects as well as to follow their condition. Importantly, those who have been previously treated with systemic therapy for an existing melanoma or treated with similar drug agents will be excluded from the study.

The trial identifier is NCT02224781 and more information can be found here and in the ECOG-ACRIN website.

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