In short
Clinical trials of Autogene Cevumeran are studying whether it can help people with certain cancers, including colorectal cancer and advanced melanoma. These studies look at how well it works and how safe it is in specific patient groups, such as people after surgery for colorectal cancer or people with previously untreated advanced melanoma.
Key points
- Clinical trials of Autogene Cevumeran are studying two cancer settings: colorectal cancer after surgery and previously untreated advanced melanoma. Both studies are phase 2 trials, which means they are checking whether the treatment may help a specific patient group while also gathering safety information. In colorectal cancer, the trial compares Autogene Cevumeran with watchful waiting in patients with ctDNA-positive disease after surgery. In melanoma, the study compares Autogene Cevumeran plus pembrolizumab with pembrolizumab alone. The main results being measured are disease-free survival and progression-free survival.
Clinical trial overview
Autogene Cevumeran is being studied in two phase 2 clinical trials for cancer. These trials are looking at different cancer types: colorectal cancer after surgery and previously untreated advanced melanoma.
Both studies are interventional, which means researchers assign a treatment so they can compare results between groups.
Colorectal cancer study
NCT04486378 is a phase 2 trial in patients with ctDNA-positive, resected Stage II high-risk and Stage III colorectal cancer. The title also includes Stage II or Stage III rectal cancer and Stage II high-risk or Stage III colon cancer.
This study compares RO7198457, which is named as Autogene Cevumeran in the trial record, against watchful waiting. Watchful waiting means the patient is closely observed without immediate active treatment.
The brief summary says the goal is to show that RO7198457 is better than watchful waiting for disease-free survival in chemotherapy-pretreated patients. The trial is authorised and plans to enroll 327 people.
Melanoma study
2023-507389-15-00 is a phase 2 trial in previously untreated advanced melanoma. It compares RO7198457, named as Autogene Cevumeran in the trial record, plus pembrolizumab versus pembrolizumab alone.
The study is completed and enrolled 130 patients. Its goal is to evaluate both efficacy and safety, and the main outcome is progression-free survival.
Main endpoints measured
The colorectal cancer trial uses disease-free survival (DFS) as its primary outcome. DFS measures the time from randomization until the cancer comes back in the same area, spreads to distant sites, a second cancer appears, or death occurs.
The melanoma trial uses progression-free survival as its primary outcome. This means the study measures how long patients live without the cancer getting worse.
Who the trials are for
The colorectal cancer trial is focused on patients who have already had surgery and still have a higher risk of cancer returning because their blood test is ctDNA-positive. The trial includes people with rectal cancer and colon cancer in the stages listed in the study record.
The melanoma trial is for people with advanced melanoma who have not yet received treatment for that disease. It tests whether adding Autogene Cevumeran to pembrolizumab can improve results compared with pembrolizumab alone.
How the studies are designed
Both trials are designed to compare Autogene Cevumeran with another approach, so researchers can see whether the study treatment improves cancer outcomes. The colorectal cancer trial uses watchful waiting as the control, while the melanoma trial uses pembrolizumab alone as the control.
These studies are not the same disease, but they share a common purpose: to test whether Autogene Cevumeran can improve key cancer outcomes in selected patient groups.