ICON: Immunotherapy in combination with chemotherapy

ICON is a randomized phase IIb study evaluating immune stimulating chemotherapy combined with ipilimumab and nivolumab in patients with luminal B breast cancer.

Immunotherapy has improved the treatment of several cancer forms the last couple of years. Antibodies blocking the break mechanisms in the immune system have shown efficiency in treatment of e.g. malignant melanoma. The drugs block molecules that the cancer cells use to become «invisible» to the immune system, thus an immune response can attack the cancer cells. Several drugs of this class exists, but none are routinely used in breast cancer treatment today.

Some types of chemotherapy initiate an immune response. These drugs kill the cancer cells in a way that send signals to the immune system, thus an immune response against the remaining cancer cells is initiated.

In the ICON study we want to test whether the combination of immune stimulating chemotherapy is more efficient than the same chemotherapy given as mono treatment.

The target group for this study is luminal B subtype breast cancer patients with metastasis. The luminal B subtype is an aggressive form of hormone sensitive breast cancer. The patients eligible for the ICON study can not have received more than one line of chemotherapy after the metastasis diagnosis, but several lines of hormone therapy is acceptable. The patients will be randomly distributed into two treatment arms: 40 % of the patient will get immune stimulating chemotherapy alone (doxorubicin and cyclophosphamide), and 60 % will in addition receive two immunotherapeutic drugs, nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor). If a patient is submitted for the chemotherapy alone and this does not show sufficient effect to prevent disease progression, the patient can be offered immunotherapy.

Oslo University Hospital is the coordinating center for the study. The treatment will be offered at Oslo University Hospital, Stavanger University Hospital and Sørlandet Hospital Kristiansand. Patients from all over the country can be referred to these centers by the general practitioner or other hospitals.

PI: Jon Amund Kyte, Oslo University Hospital.