NCT01688973.

Methods	Study type: interventional, randomised, parallel assignment, phase II Blinding: no, open‐label Accrual period: August 20, 2012 ‐ April 30, 2017 Cross‐over study: no Status: completed (as of January 3, 2019)
Participants	Estimated enrolment: N =55 Risk groups: no information Inclusion criteria: participants must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic, or locally advanced and unresectable; mixed histologies will be allowed provided that they contain >= 50% of the papillary component participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension participants with metastatic disease who have a resectable primary tumour and are deemed a surgical candidate may have undergone resection participants with a history of brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti‐seizure medications are allowed provided they are non‐enzyme inducing participants may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma; participants must not have received a MET inhibitor or erlotinib as prior therapy; at least 21 days must have elapsed since completion of prior systemic therapy, 42 days for nitrosourea or mitomycin C; participants must have recovered from all associated toxicities at the time of registration participants may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy; participants must have recovered from all associated toxicities at the time of registration participants must not be receiving or planning to receive any other investigational agents More inclusion criteria on CT.gov. Exclusion criteria: not reported Sample size: N = 55, 50 participants were analysed Age, median (years, range): experimental arm: 63.6 (22.8‐81.9), control arm: 62.1 (20.3 ‐ 76.1) Sex (m/f, (%)): experimental arm: 15/10 (60/40), control arm: 19/6 (76/24) Prognostic factors: Previous nephrectomy, n(%) Yes experimental arm: 18 (72), control arm: 21 (84)
Interventions	Experimental arm (n = 25): tivantinib orally twice daily and erlotinib hydrochloride orally once daily on days 1‐28 Control arm (n = 25): tivantinib orally twice daily on days 1‐28
Outcomes	Primary outcome(s) ‐ Secondary outcome(s) Frequency and severity of toxicities, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (time frame: up to 3 years) PFS (time frame: 30 months) Relevant to this review but not listed on CT.gov: OS, TFST, QoL, number of participants who discontinued treatment Other outcomes (not relevant to this review): response rate
Notes	Previous therapy: participants may have received prior therapy (see inclusion criteria). Awaiting results to check whether results for treatment‐naive participants are reported separately.