Brief Summary
The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinomacancer arising from tissues that line organs (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
Intervention / Treatment
- Biological: V940
- Biological: Pembrolizumab
- Biological: Placebo
Inclusion Criteria
- Has histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of renal cell carcinoma (RCC) with clear cell or papillary histology.
- Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasiswhen the cancer has spread to other parts of the body, also known as mets and tumor grading:
- Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
- High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
- M1 NED RCC participants who present not only with the primary kidneya pair of bean-shaped organs in the abdomen that are responsible for filtering excess water and waste products from the blood and converting them into urine to be removed from the body tumor, but also solid, isolated, soft tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints metastases that can be completely resected at 1 of the following: the time of nephrectomycomplete or partial removal of affected kidney(s) (synchronous), or ≤2 years from nephrectomy (metachronous)
- Has undergone complete resectionsurgical removal of tissue or part/all of an organ of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissuea group of cells that work together to perform a function metastatic lesion(s) in M1 NED participants.
- Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence and any post-operative complications before randomization.
- Has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1 within 7 days before randomization.