Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system CNS -directed therapy shows no evidence of progression within 4 weeks prior to randomization Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
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A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1 has achieved menarche at some point, 2 has not undergone a hysterectomy or bilateral oophorectomy; or 2 has not been naturally postmenopausal amenorrhea following cancer therapy does not rule out childbearing potential for at least 24 consecutive months i. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
To be eligible for this trial, patients should be class 2B or better. Patients with a history of congestive heart failure CHF or who are at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs must be willing to undergo evaluation of cardiac function including electrocardiogram EKG and echocardiogram ECHO as clinically indicated Patient must have the ability to understand and the willingness to sign a written informed consent document.
OncologyResearchSupport providence. Boucher providence. Research flhosp. Research rushcopley. Smith3 nm. Crofts trinity-health.
