| Methods |
Study type: interventional, randomised, parallel assignment, phase II
Blinding: no, open‐label
Accrual period: May 15, 2018 ‐ July 31, 2022 (estimated study completion date)
Countries: multicenter (N = 3 in the USA)
Cross‐over study: no
Status: active, not recruiting (as of June 1st, 2022) |
| Participants |
Estimated enrolment: N = 84
Risk groups: no information
Inclusion criteria:
the participant has a histologic or cytologic diagnosis of a variant histology renal cell carcinoma including papillary, chromophobe, Xp.11 translocation, undifferentiated, or unclassified which is treatment‐naïve or has previously been treated with one systemic treatment line not containing any vascular endothelial growth factor antibody or vascular endothelial growth factor receptor tyrosine kinase inhibitors. The patient may have received treatment with immune checkpoint therapy including nivolumab as a single agent or nivolumab plus ipilimumab in combination. Previous treatment with mammalian target of rapamycin agents such as temsirolimus or everolimus is acceptable measurable disease per RECIST v1.1 as determined by the investigator the participant has had an assessment of all known disease sites e.g. by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib or sunitinib the participant is >/=18 years old on the day of consent the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of </=2 recovery to baseline or </= Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are clinically non significant and/or stable on supportive therapy
Exclusion criteria:
the participant has a variant histology that includes renal medullary carcinoma or collecting duct renal cell carcinoma. Any clear cell component in the tumour will lead to exclusion the participant has received any previous anti‐angiogenic agent. Prior treatment with cabozantinib radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible the participant has received any other type of investigational agent within 28 days before the first dose of study treatment known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible participants must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
More inclusion and exclusion criteria on CT.gov. |
| Interventions |
Experimental arm: cabozantinib orally once daily on days 1‐42)
Control arm: sunitinib malate (orally once daily on days 1‐28 |
| Outcomes |
Primary outcome(s)
Secondary outcome(s)
Relevant to this review but not reported: SAE, TFST, participants who discontinued treatment due to an AE, QoL
Other outcomes (not relevant to this review): ORR |
| Notes |
Funding sources: M.D. Anderson Cancer CenterExelixisNational Cancer Institute (NCI)
Previous therapy: participants may have received prior therapy (see inclusion criteria). Awaiting results to check whether results for treatment‐naive participants are reported separately. |
