A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).

Inclusion Criteria:

• Has histologically or cytologically confirmed diagnosis 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 asdefined by the following pathological tumor-node metastasis 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 kidney tumor, but alsosolid, isolated, soft tissue metastases that can be completely resected at 1 of thefollowing: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous)

• Has undergone complete resection of the primary tumor (partial or radicalnephrectomy) and complete resection of solid, isolated, soft tissue metastaticlesion(s) in M1 NED participants.

• Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior torandomization and recovered from surgery and any post-operative complications beforerandomization.

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

Exclusion Criteria:

• Has had a major surgery other than nephrectomy plus resection of preexistingmetastases for M1 NED participants, within 4 weeks prior to randomization.

• Has residual thrombus post nephrectomy in the vena renalis or vena cava.

• Received prior systemic anticancer therapy including investigational agents within 4weeks before randomization.

• Received prior radiotherapy within 2 weeks of start of study intervention, orradiation-related toxicities, requiring corticosteroids.

• Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention. Administration of killed vaccines is allowed.

• Received prior treatment with a cancer vaccine.

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy.

• Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years.

• Has a history of brain or bone metastatic lesions.

• Has severe hypersensitivity to study medication or any of the substances used toprepare the study medication.

• Has an active autoimmune disease that has required systemic treatment in the past 2years

• Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease

• Has an active infection requiring systemic therapy

• History of allogeneic tissue/solid organ transplant

• Has not adequately recovered from major surgery or has ongoing surgicalcomplications