Protocol: SWOG – S2200
Please Note: Below is partial eligibility, for full eligibility requirements, please contact Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!
Eligibility:
- Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component.
- Participants must have measurable disease. All measurable lesions must be assessed by CT or MRI within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration).
- Participants with new or progressive brain metastases (active brain metastases) must not require immediate CNS specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling.
- Participants with measurable disease, per RECIST v1.1, must be present outside the CNS.
- Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage.
- Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
- Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease.
- Participants, if needed, must receive a stable dose of anti-convulsant therapy.
- Participants must not have cavitating pulmonary lesions.
10. Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery.
11. Participants must not have had prior treatment with cabozantinib for any reason.
12. Participants must not have had prior treatment or adjuvant therapy with PD-1/PDL1 checkpoint inhibitors for any reason within the past 6 months.
13. Participants must not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor FDA-approved for advanced RCC (i.e., pazopanib, bevacizumab,
sorafenib or axitinib). If a participant develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC.
14. Participants must complete all prior radiation therapy at least 14 days prior to registration. Participants must have recovered to ≤ grade 1 from all associated toxicities at the time of registration unless the toxicity is determined to be not
clinically significant by the registering investigator.
15. Participants must not be receiving or planning to receive any other investigational agents at time of registration.
16. Participants must be ≥ 18 years of age.
17. Participants must have a Zubrod performance status of 0-2.
18. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.