Not recruiting

Study of V940 and Pembrolizumab for Patients with Renal Cell Carcinoma After Surgery

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of kidney cancer known as Renal Cell Carcinoma (RCC). The study involves patients who have undergone surgery to remove the kidney tumor and, in some cases, additional cancerous tissue. The trial is testing a combination of treatments to see if they can help prevent the cancer from returning. The treatments being studied are V940 (mRNA-4157) and Pembrolizumab (MK-3475), which will be compared to a placebo combined with Pembrolizumab. Pembrolizumab is a medication that helps the immune system fight cancer, while V940 is a new type of treatment that uses a small piece of genetic material to help the body recognize and attack cancer cells.

The purpose of this study is to compare the effectiveness of V940 plus Pembrolizumab against a placebo plus Pembrolizumab in preventing the return of cancer after surgery. Participants will receive these treatments through injections or infusions over a period of time. The study will monitor how long participants remain free of cancer and will also track any side effects they may experience. The trial aims to provide valuable information on whether this combination of treatments can improve outcomes for patients with RCC.

Participants in the study will be closely monitored by healthcare professionals throughout the trial. The study will assess how well the treatments work in keeping the cancer from coming back and will also look at the overall survival of participants. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments being tested.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant is randomly assigned to one of two groups: one receiving the experimental treatment and the other receiving a placebo.
The study involves participants with renal cell carcinoma (RCC) who have undergone surgery to remove the tumor and any metastases.
Step 2
Treatment administration
Participants in the experimental group receive pembrolizumab and mRNA-4157. Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein. The dosage is 25 mg/mL.
The mRNA-4157 is given as an intramuscular injection, which means it is injected into a muscle.
Participants in the placebo group receive a placebo along with pembrolizumab.
Step 3
Monitoring and follow-up
Participants are monitored for disease-free survival, which means checking if the cancer returns or not.
Other aspects monitored include distant metastasis-free survival, overall survival, and any adverse events experienced by participants.
The study aims to continue until May 2027, with regular follow-ups to assess the health and progress of participants.

Who can join the trial?

9 criteria

The patient must have a confirmed diagnosis of renal cell carcinoma (RCC), which is a type of kidney cancer, with either clear cell or papillary histology. Histology refers to the study of the tissue under a microscope.
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The patient must have one of the following types of RCC:
- Intermediate-high-risk RCC: This means the cancer is at stage pT2 with grade 4, no lymph node involvement (N0), and no distant spread (M0), or stage pT3 with grade 3 or 4, N0, M0.
- High-risk RCC: This means the cancer is at stage pT4, N0, M0, or any stage with lymph node involvement (N1), but no distant spread (M0).
- M1 NED RCC: This means the patient had the primary kidney tumor and isolated soft tissue metastases, which are cancerous growths that can be completely removed, either at the time of kidney removal surgery (nephrectomy) or within 2 years after the surgery.
- The patient must have had complete removal of the primary kidney tumor through surgery, which can be partial or complete removal of the kidney (nephrectomy), and complete removal of any isolated soft tissue metastases if they have M1 NED RCC.
- The patient must have had the nephrectomy and/or metastasectomy (surgery to remove metastases) within 12 weeks before being randomly assigned to a treatment group in the study and must have recovered from the surgery and any complications.
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before being randomly assigned to a treatment group. This status is a measure of the patient's ability to perform daily activities, where 0 means fully active and 1 means restricted in physically strenuous activity but able to carry out light work.
- The patient must be within the age range specified for the study.
- Both male and female patients are eligible to participate.

Who cannot join the trial?

4 criteria

Patients who have not had surgery to remove the kidney (nephrectomy) or surgery to remove cancer that has spread (metastasectomy) cannot participate.
Patients with medical conditions other than intermediate-high risk RCC, high-risk RCC, or M1 NED RCC are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany

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Investigated drugs

V940 (mRNA-4157)
is an investigational medication being studied for its potential to help the immune system recognize and fight cancer cells. It is designed to work by using messenger RNA (mRNA) technology to instruct the body to produce proteins that may trigger an immune response against cancer.
Pembrolizumab (MK-3475)
is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific protein on the surface of immune cells, allowing them to better recognize and attack cancer cells. Pembrolizumab is used in various types of cancer treatments and is being studied in combination with other therapies to improve its effectiveness.

What is already known about the treatment

Pembrolizumab
This medication is administered through an intravenous infusion. It is currently well-established in medical literature as an immunotherapy used to treat various types of cancer. The main therapeutic indication for pembrolizumab in this trial is renal cell carcinoma (RCC) in patients who have undergone nephrectomy, with or without metastasectomy. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody.
V940 (mRNA-4157)
This investigational medication is administered via injection. It is currently being studied in clinical trials and is not yet widely used in standard medical practice. The main therapeutic indication for V940 in this trial is as an adjuvant treatment for renal cell carcinoma (RCC) in patients who have undergone nephrectomy. The mechanism of action involves using mRNA technology to instruct cells to produce proteins that stimulate an immune response against cancer cells. It is classified as an mRNA-based therapeutic.

Investigated diseases

Renal Cell Carcinoma (RCC) – Renal Cell Carcinoma is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is characterized by the abnormal growth of cells in the kidney, which can form a mass or tumor. The disease can be classified into different risk categories, such as intermediate-high risk and high risk, based on factors like tumor size and spread. In some cases, the cancer may spread to other parts of the body, a process known as metastasis. Patients who have undergone surgical removal of the kidney (nephrectomy) and metastasectomy may be monitored for disease progression. The progression of RCC can vary, with some cases remaining localized while others may spread to distant organs.