Bristol Myers Squibb (BMS) is currently recruiting candidates for CheckMate 914 study, to evaluate the potential role of immuno-oncology agents nivolumab and ipilimumab for early-stage, high-risk renal cell carcinoma (RCC)
CheckMate 914 is a randomized, phase 3 double blind clinical trial evaluating adjuvant nivolumab alone or in combination with ipilimumab vs Placebo in patients who underwent radical or partial nephrectomy and who are at high risk of relapse.
As registered with ClinicalTrials.gov (NCT03138512), the CheckMate 914 trial is comprised of patients who underwent radical or partial nephrectomy with negative surgical margins at least four weeks and less than 12 weeks prior to randomization with a targeted accrual of 1,600 patients. All treatments are given for 24 weeks or until disease recurrence, unacceptable toxicity, or withdrawal of consent. The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced partial or entire removal of a kidney. The primary outcome is disease-free survival according to blinded independent central review. Key secondary outcomes include overall survival.
To find out if your patients are eligible for this trial, check out below link:
Kidney tumor has been completely resected with negative surgical margins obtained.
Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
Post-nephrectomy tumor shows RCC with a predominantly clear cell histology.
Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
ECOG Performance Status (0 - 1)
Participants with an active known or suspected autoimmune disease
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell con-stimulation or checkpoint pathways
Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
History of allergy or hypersensitivity to study drug components
Participants with a condition requiring systemic treatment with corticosteroids
Participants who have received a live/attenuated vaccine within 30 days of first treatment
* Other protocol defined inclusion/exclusion criteria apply
The newly developed recommendations by NCI and FDA allows increasing flexibility for trial investigators to reduce COVID-19 exposure or offers alternative care settings to improve the overall trial process during the COVID-19 pandemic.
To find out if your patients are eligible for this trial, CLICK BELOW LINK