NCT01392183.

Study characteristics
Methods	Study name: TemPa Study design: a two‐arm, RCT, phase II Blinding: none, open‐label Study dates: November 2012 ‐ June 2017 (date of enrolment) Date of data cut‐off: not reported Location: 1 country (USA), type of centre: cancer centre (1 study location) Cross‐over study or cross over permitted: yes, cross‐over study* *For cross‐over studies, only data on period 1 were extracted for analyses.
Participants	Inclusion criteria: all sexes 18 years and older pathologic confirmation of metastatic or locally advanced RCC with a major clear cell component measurable disease by RECIST criteria age >/= 18 years ECOG PS 0‐2 or KPS >/= 60% meets criteria for poor‐risk defined as 3 or more of the following: ECOG performance status 2, anaemia (haemoglobin lower than reference range), elevated serum LDH > 1.5x upper limit of normal (ULN), hypercalcaemia (corrected serum calcium level > upper limit of normal), time from initial RCC diagnosis to registration on this trial < 1 year, and > 1 metastatic organ sites Exclusion criteria: prior malignancy, except for non‐melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years prior targeted therapy (anti‐VEGF agents or mTOR inhibitors) including adjuvant therapy, and prior chemotherapy for mRCC. However, prior immunotherapy (cytokines or vaccines) is allowed any experimental drug while on this study; however, concomitant bone targeted therapy (bisphosphonates or the anti‐RANK ligand denosumab) is allowed uncontrolled brain metastases and infections. participants with brain metastases treated with Gamma Knife (GK) or whole brain radiation within 24 hours of registration major surgery within 28 days prior to registration Sample size: N=69 Age (median, range (years)): experimental arm: 61 (42‐80), control arm: 61 (37‐74) Sex (m/f): experimental arm: 24/11, control arm: 28/6 Prognostic factors: ECOG Performance Scale, n(%) 0 experimental arm: 1 (2.9), control arm: 1 (2.9) 1 experimental arm: 14 (40), control arm: 12 (35.3) 2 experimental arm: 20 (57.1), control arm: 21 (61.8) Previous nephrectomy Yes experimental arm: 15 (42.9), control arm: 15 (44.1) IMDC risk Intermediate experimental arm: 11 (31.4), control arm: 8 (23.5) Poor experimental arm: 24 (68.6), control arm: 26 (76.5) Previous IL‐2 experimental arm: 2 (5.7), control arm: 1(2.9)
Interventions	Experimental arm (n = 35 ): temsirolimus (25 mg, intravenous, once/week) Control arm( = 34): pazopanib (800 mg, oral, once/day)
Outcomes	Primary outcome(s) PFS Time frame: assessments every 8 weeks from baseline to 1 year Secondary outcome(s) OS Time frame: assessments every 8 weeks from baseline to 1 year Number of participants who discontinued treatment due to an AE Safety (AEs) Relevant to this review but not reported: SAEs, QoL, TFST Other outcomes (not relevant to this review): ‐
Notes	Funding sources: Novartis Pharmaceuticals and in part by the Cancer Center Support Grant (NCI Grant P30 CA016672) Declarations of Interests: Quote;"Nizar M. Tannir certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g. employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Tannir has received grant funding and personal fees for consultancy from Pfizer and Novartis. Karam has received personal fees for consultancy from Pfizer. Wood has received grant funding from Pfizer. Zurita has received grant funding and personal fees for consultancy from Pfizer, and grant funding from Novartis." Clinical study report available: no Study protocol available: no Statistical analysis plan available: no