{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"}],"units":"Participants"}],"description":"Dose-limiting toxicity (DLT) were defined as any treatment-related grade 3 or 4 nonhematologic toxicity during the first cycle of therapy, including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities during the first cycle of therapy: thrombocytopenia and neutropenia of more than 7 days duration, neutropenia of any duration with fever or documented infection; additionally, treatment delay of 14 days or greater during Cycle 1 due to unresolved toxicity will be considered a DLT.","groups":[{"description":"Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial.\n\nBiospecimen Collection: Undergo blood sample collection\n\nCabozantinib S-malate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nNivolumab: Given IV","id":"OG000","title":"Treatment (Cabozantinib S-malate, Nivolumab)"}],"paramType":"NUMBER","populationDescription":"All treated patients","reportingStatus":"POSTED","timeFrame":"28 days","title":"Incidence of Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"patients"}