Phase 1 Study of CVX1 Vaccine With or Without Immune Checkpoint Inhibitors in Muscle Invasive Bladder Cancer or Localized/Locally Advanced Renal Cell Cancer

The primary objective of this phase 1 study is to evaluate the safety, tolerability, and immunogenicity of the E-VIM vaccine CVX1, administered either alone or in combination with immune checkpoint inhibitors (ICI). This assessment is critical for determining the initial risk profile and the capacity of the vaccine to elicit a targeted immune response in patients presenting with muscle invasive bladder cancer or localized or locally advanced renal cell cancer. Trial scope: 4, 5, 6.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients including both males and females within the age ranges of 3 and 4. Eligible participants are diagnosed with metastatic solid cancer, muscle invasive bladder cancer, or localized or locally advanced renal cell cancer.

This Phase 1 study is designed to evaluate the safety, tolerability, and immunogenicity of the E-VIM vaccine CVX1, administered either alone or in combination with immune checkpoint inhibitors. The research targets subjects diagnosed with muscle invasive bladder cancer or localized or locally advanced renal cell cancer. The study follows a methodology to assess the clinical response and immunological profile of the intervention. The clinical procedure begins with a screening visit to determine eligibility based on specific diagnostic criteria. Subsequent study visits will involve administration of the investigational products and monitoring for adverse events. The protocol includes follow-up assessments and a final end-of-study visit to collect long-term data. The total duration of the study is estimated to span from April 2026 to March 2029. Participant involvement may be subject to early termination based on predefined safety protocols or clinical criteria.

The assessment of efficacy in this Phase I clinical trial involves evaluating therapeutic responses in patients diagnosed with metastatic solid cancer, muscle invasive bladder cancer, or localized or locally advanced renal cell cancer.