The purpose of this trial is to find out how safe and effective it is to have either one or two immunotherapy drugs alongside the parp inhibitor Rucaparib. Researchers want to find out if using the different combination of drugs will prolong the time it takes for your cancer to come back compared with being treated with Rucaparib on its own.
The drugs involved in this trial are:
- Rucaparib – a PARP inhibitor. This is a tablet taken by mouth.
- Nivolumab – an antibody, which blocks a receptor called Programme Death Receptor-1 (PD-1) on the surface of your T cells (immune fighting cells). By blocking these receptors, the antibodies are thought to help your immune system fight cancer cells. It's been approved and licensed in the UK for standard use in lung cancer, advanced melanoma and kidney cancer. Nivolumab is given intravenously (through a vein).
- Ipilimumab – an antibody which blocks a different receptor called Cytotoxic T-Lymphocyte Antigen-4 (CTLA4) on the surface of T cells (immune fighting cells). By blocking these receptors, the antibodies help your immune system to fight your cancer cells. Ipilimumab has been used in the treatment of more than 19,000 patients. It's been approved and licensed in the UK for standard use in patients with advanced melanoma. Ipilimumab is given intravenously (through a vein).
Researchers are testing these drugs in women who either:
- have a mutation in their BRCA 1 or 2 genes
- have normal BRCA genes but they show Loss of Heterozygosity (LoH) in their tumour genes
Loss of heterozygosity is a scoring system applied to tumour tissue to reflect how much scarring is present in the genes of that tissue. One of the drugs used in this study, rucaparib, has been shown to prolong the remission of those patients carrying the BRCA1 and 2 genetic mutations. Rucaparib also prolongs remission in patients with normal BRCA and a high LoH score, but not generally for as long as it can for women with BRCA1 and 2 gene mutations.
