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Nivolumab (brand name Opdivo): IV, administered per standard of care according to institutional guidelines at the discretion of the treating medical oncologist, until disease progression or unacceptable toxicity; SABR, dose variable, in 1-3 fractions.
Full description
A single institution, safety lead-in phase II trial with SAbR to multiple metastatic sites concurrently administered with Nivolumab for patients with metastatic clear cell renal cell cancer who have failed at least one anti-angiogenic therapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
At least 18 years of age
Willing and able to provide consent
Pathologic diagnosis of metastatic RCC with clear cell component
Measurable disease in at least 2 non-radiated sites. Progression or intolerance to at least one prior systemic anti-angiogenic therapy.
Eligible for extra-CNS SAbR to 1-6 sites of disease
Must have received at least one prior anti-angiogenic therapy in the advanced or metastatic setting. Prior cytokine therapy (eg, IL-2, IFN-α), vaccine therapy, or treatment with cytotoxic therapy is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Previous treatment with surgery, radiation, chemotherapy, targeted agents (see above) are allowed provided that: Chemotherapy/Major surgery was administered > 14 days before the start Nivolumab; Minor surgery, radiation, or any targeted agents were administered > 7 days before the start of Nivolumab
Performance status ECOG 0, 1, 2 or 3.
Adequate organ and marrow function as defined below (obtained within 14 days of first dose of drug):
Women of child-bearing potential
Adequate Renal function with Cr ≤ 2.5 mg/dL.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
7 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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