| Study name |
‐ |
| Methods |
Study type: RCT, early phase I, parallel assignment
Blinding: no, open‐label
Accrual period: November 25, 2014 ‐ May 21, 2020 (final data collection date for primary outcome measure))
Countries: no information
Cross‐over study: no
Status: active, not recruiting (as of March 23, 2020) |
| Participants |
Estimated enrolment: N=105
Inclusion criteria:
participants must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy participants with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy, metastasectomy or post‐treatment biopsy; diagnosis must be confirmed by pathologist review of screening biopsy; the determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient participants must have measurable disease and is defined as a lesion that can be accurately measured on the long axis with a minimum size of 10 mm or a lymph node that can be accurately measured along the short axis of a minimum size of 15 mm (computed tomography [CT] scan slice thickness can be no greater than 5 mm) participants can have had prior treatment for RCC including prior surgery, radiation therapy, immunotherapy with interleukin (IL)‐2 or interferon (but not anti‐programmed cell death [PD]1 or anti‐cytotoxic T‐lymphocyte‐associated protein 4 [CTLA‐4]), target therapy with receptor tyrosine kinase (RTK) inhibitors/mammalian target of rapamycin (mTOR) inhibitors, such as sunitinib, sorafenib, pazopanib, axitinib, everolimus, and temsirolimus (but not bevacizumab) or chemotherapy
Exclusion criteria:
any other malignancy from which the patient has been disease‐free for less than 2 years, except for non‐melanoma skin cancer, in situ carcinoma of any site participants who have organ allografts participants who have had a 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 defined by protocol); or fine needle aspirations or core biopsies within 7 days prior to first dose of study drug known or suspected autoimmune disease; participants with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are participants with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]) are excluded from this study; any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug; inhaled steroids and adrenal replacement steroids doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhoea
More inclusion and exclusion criteria on CT.gov. |
| Interventions |
Experimental arm I: Nivolumab + Bevacizumab + surgery
Experimental arm II: Nivolumab + Ipilimumab + surgery
Control arm: Nivolumab + surgery |
| Outcomes |
Primary outcome(s)
incidence of adverse events, defined any grade 3 or higher adverse event that is possibly, probably, or definitely related to any therapy received on this protocol (time frame: 6 weeks)
Secondary outcome(s)
Relevant to this review but not reported: TFST, participants who discontinued treatment due to an AE, safety (AEs/SAEs)
Other outcomes (not relevant to this review): ORR, DoR, immunological changes in tumour tissue and peripheral blood |
| Starting date |
25.11.2014 |
| Contact information |
Padmanee Sharma (M.D. Anderson Cancer Center) |
| Notes |
Funding sources: M.D. Anderson Cancer Center, National Cancer Institute (NCI) |
