Study on V940 and Pembrolizumab for Kidney Cancer (V940-004)

Inclusion Criteria

• Diagnosed with kidney cancer (renal cell carcinoma) with specific cell types (clear cell or papillary).
• Classified as having intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) kidney cancer based on specific medical criteria.
• Intermediate-high-risk: Tumor stage pT2, grade 4, no lymph node involvement, no metastasis; or tumor stage pT3, grade 3/4, no lymph node involvement, no metastasis.
• High-risk: Tumor stage pT4, no lymph node involvement, no metastasis; or any tumor stage with lymph node involvement, no metastasis.
• M1 NED: Primary kidney tumor with isolated, removable soft tissue metastases, either at the time of kidney surgery or within 2 years after.
• Must have had complete removal of the primary tumor and any isolated metastases.
• Surgery (nephrectomy and/or metastasectomy) must have been done within 12 weeks before joining the study, with recovery from surgery and any complications.
• Must be in good general health with an ECOG performance status of 0 or 1 within 7 days before joining the study.

Exclusion Criteria

• Had major surgery other than kidney removal and metastasis resection within 4 weeks before joining the study.
• Has a blood clot remaining in the kidney vein or vena cava after kidney removal.
• Received any cancer treatment, including experimental drugs, within 4 weeks before joining the study.
• Had radiation therapy within 2 weeks before starting the study treatment, or has side effects from radiation that need steroids.
• Received a live vaccine within 30 days before the first dose of study treatment. Killed vaccines are allowed.
• Previously treated with a cancer vaccine.
• Has an immune deficiency or is on long-term steroid treatment.
• Has another active cancer that has needed treatment in the past 3 years.
• Has a history of cancer spread to the brain or bones.
• Has severe allergies to the study medication or its components.
• Has an active autoimmune disease needing treatment in the past 2 years.
• Has a history of lung inflammation needing steroids or currently has lung inflammation.
• Has an active infection needing treatment.
• Has had a tissue or organ transplant.
• Has not fully recovered from major surgery or has ongoing surgical issues.