This phase 2 trial will investigate the safety and efficacy of niraparib (Zejula) in advanced melanoma with abnormal genes.
The main outcome will be the objective response rate (ORR). This trial is recruiting in California, United States.
The details
In many cases, melanoma is not diagnosed until an advanced stage. Melanoma can be aggressive and standard treatment may not always prevent cancer growth. Many new drug targets have been identified in advanced cancers including melanoma. Gene mutations (abnormalities) are common in melanoma. One treatment target is a molecular pathway that tumor cells use to repair DNA. This is called the homologous repair pathway (HRP). PARP inhibitors are drugs that target the HRP. This stops cancer cell growth. Niraparib is a PARP inhibitor. It is already licensed to treat ovarian cancer.
This trial will investigate the safety and efficacy of niraparib in advanced melanoma. The main outcome will be the ORR.
Who are they looking for?
This study will include 41 participants with advanced melanoma.Participants must have a HRP mutation. Patients must have been unable to tolerate standard treatments or have cancer that has progressed under standard treatments. Any side events from standard treatment must be resolved.
Patients cannot take part in the trial if they have had previous treatment with a PARP inhibitor. Patients with brain metastasis (tumors) cannot take part in the trial. Other exclusion criteria are immune system conditions, steroid treatment, treatment for another cancer in the last 2 years or cancer treatment in the previous 14 days.
How will it work
All patients will be treated with nariparib. It will be taken orally. Patients will take a 300 mg dose of nariparib every day. This will continue until the disease progresses or the side effects are intolerable. The trial will last up to 2 years.
