NCT03075423.

Study name	SUNIFORECAST
Methods	Study type: RCT, phase II, parallel assignment Blinding: no, open‐label Accrual period: November 1, 2017 ‐ December 31, 2023 (estimated study completion date) Countries: international (Belgium, Czechia, France, Germany, the Netherlands, Spain, the UK), multicentre (40 study locations) Cross‐over study: no Status: Recruiting (as of February 23, 2022)
Participants	Estimated enrolment: N = 306 Inclusion criteria: Histological confirmation of non‐clear cell renal cell carcinoma (nccRCC) with at least 50% non‐clear cell component according to actual World Health Organization (WHO) classification Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) nccRCC Performance status: Karnofsky (KPS) > 70% (See Appendix 2, 14.2) d) Measurable disease as per RECIST v 1.1 (See Appendix 3, 14.3) documented by an English radiology report Participants with all risk categories will be eligible for the study. Patients will be stratified for papillary or non‐papillary non‐clear cell histology and IMDC risk score. Patients will be categorised according to favourable versus intermediate versus poor risk status at registration according to the International Metastatic RCC Database Consortium (IMDC) criteria Males and females, > 18 years of age Exclusion criteria: any active brain metastases requiring systemic corticosteroids. Baseline imaging of the brain by MRI is required in participants with clinical signs of potential central nervous system (CNS) involvement within 28 days prior to randomisation tumours with a clear‐cell component of > 50%Medical History and Concurrent Diseases prior systemic treatment with vascular endothelial growth factor (VEGF) or VEGF receptor targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab) or prior treatment with an mammalian target of rapamycin (mTOR) inhibitor or cytokines prior treatment with an immune checkpoint inhibitor as anti‐programmed cell death (PD)PD‐1, anti‐PD‐L1, anti‐PD‐L2, anti cytotoxic T‐lymphocyte‐associated Protein 4 (CTLA 4) antibody, or any other antibody or drug specifically targeting T‐cell co‐stimulation or checkpoint pathway history of deep vein thrombosis (DVT) unless adequately treated with low molecular weight heparin prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast known medical condition (e.g., a condition associated with diarrhoea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results major surgery (e.g., nephrectomy) < 28 days prior to the first dose of study drug anti‐cancer therapy < 28 days prior to the first dose of study drug or palliative, focal radiation therapy < 14 days prior to the first dose of study drug receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors (See Appendix 4, 14.4). hypersensitivity to sunitinib or any of the excipients More inclusion & exclusion criteria on CT.gov.
Interventions	Experimental arm: Iplilmumab + Nivolumab Control arm: Sunitinib
Outcomes	Primary outcome(s): OS (Time frame: 12 months) Secondary outcome(s): OS (time frame: 6 and 18 months) OS (lime frame: 5 years) PFS (time frame: 5 years) Safety (AEs/SAEs) (time frame: 5 years) QoL (time frame: 5 years) Relevant to this review but not reported: TFST, number of patients who discontinued treatment Other outcomes (not relevant to this review): ORR
Starting date	01.11.2017
Contact information	Lothar Bergmann, MD; Nicola Goekbuget, MD
Notes	Funding sources: Nicola Goekbuget