NCT02210117

Trial name or title	A Pilot Randomised Tissue‐Based Study Evaluating Anti‐PD1 Antibody or Anti‐PD1 + Bevacizumab or Anti‐PD1 + Anti‐CTLA‐4 in Patients with Metastatic Renal Cell Carcinoma who are Eligible for Cytoreductive Nephrectomy, Metastasectomy or Post‐Treatment Biopsy.
Methods	Study design: 3‐arm, parallel‐group, double‐blind RCT. Setting: multicentre. Countries: US.
Participants	Main inclusion criteria: informed consent; histologically or cytologically confirmed clear‐cell mRCC who are eligible for cytoreductive nephrectomy; metastasectomy or post‐treatment biopsy; diagnosis must be confirmed by pathologist review of screening biopsy; measurable disease defined as a lesion that can be accurately measured in at least 1 dimension and measures ≥ 15 mm with conventional techniques or ≥ 10 mm with more sensitive techniques such as MRI or spiral CT scan; prior treatment for RCC including prior surgery, radiotherapy, immunotherapy with IL‐2 or interferon (but not anti‐PD1 or anti‐CTLA‐4); target therapy with RTK inhibitors/mTOR inhibitors, such as sunitinib, sorafenib, pazopanib, axitinib, everolimus and temsirolimus (but not bevacizumab) or chemotherapy allowed; ECOG Performance Status 0 or 1. Main exclusion criteria: any other malignancy from which the person has been disease‐free for < 2 years, except for non‐melanoma skin cancer, in situ carcinoma of any site, organ allografts, major surgical procedure, open biopsy or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug; or anticipation of need for major surgical procedure during the course of the study (other than in protocol); autoimmune disease; known history of testing positive for HIV or known AIDS; positive test for hepatitis B virus or positive test for hepatitis C virus. Sample size planned: 60.
Interventions	Group 1: nivolumab. Group 1.1: nivolumab + bevacizumab. Group 1.2: nivolumab + ipilimumab.
Outcomes	Primary outcome: safety. Secondary outcomes: immunological changes in tumour tissue, ORR.
Starting date	November 2014.
Contact information	Padmanee Sharma, MD, PhD.
Notes	Estimated primary data: November 2018.