This trial is examining the effectiveness of nivolumab (Opdivo) in combination with cabozantinib (Cometriq) for metastatic triple-negative breast cancer (cancer that is not dependent on hormones or HER2 for growth). The outcome to be measured will be the response rate of the cancer to this treatment. This study is recruiting in Boston, Massachusetts.
There are several treatment options for hormone negative, HER-2 negative advanced breast cancer. New treatments are also being developed. Nivolumab is a treatment that inhibits proteins that can increase the body's immune response against the tumor. Cabozantinib is a treatment that targets tyrosine kinase receptors, which are also involved in cancer growth. Both nivolumab and cabozantinib have been approved for use in other types of cancer.
The main outcome to be measured is tumor response, as well as side effects experienced.
Who are they looking for?
This trial is recruiting 35 participants. Patients must agree to a biopsy of the tumor. Patients may have received 0-3 chemotherapy cycles but must be off treatment for 14 days prior to registration. Patients must also be off targeted therapy for 14 days prior to treatment. Prior radiotherapy treatment may have been carried out to bone lesions two weeks prior to treatment commencement or four weeks for any other site. Patients should have normal marrow and organ function. Participants must not be pregnant or breastfeeding and must agree to use contraception if pregnancy is possible.
Patients should not have active infections, gastrointestinal disorders, or cardiovascular disease. Patients should not have had major surgery 12 weeks prior to treatment, prior c-Met inhibitor, anti-PD-1, anti-PD-L1, anti-CD137 or CTLA-4 antibody. The patient should not have HIV.
How will it work
All patients will receive nivolumab and cabozantinib. Nivolumab will be given every 4 weeks intravenously and cabozantinib is taken daily by mouth. Patients will be followed up until 2021. Outcomes will be measured in terms of disease progression and side-effects from the treatment.