Table of contents
- Clinical trial overview
- Colorectal cancer study
- Melanoma study
- Main endpoints measured
- Who the trials are for
- How the studies are designed
Clinical trial overview
Autogene Cevumeran is being studied in two phase 2 clinical trials for cancer.[1][2] These trials are looking at different cancer types: colorectal cancer after surgery and previously untreated advanced melanoma.[1][2]
Both studies are interventional, which means researchers assign a treatment so they can compare results between groups.[1][2]
Colorectal cancer study
NCT04486378 is a phase 2 trial in patients with ctDNA-positive, resected Stage II high-risk and Stage III colorectal cancer.[1] The title also includes Stage II or Stage III rectal cancer and Stage II high-risk or Stage III colon cancer.[1]
This study compares RO7198457, which is named as Autogene Cevumeran in the trial record, against watchful waiting.[1] Watchful waiting means the patient is closely observed without immediate active treatment.[1]
The brief summary says the goal is to show that RO7198457 is better than watchful waiting for disease-free survival in chemotherapy-pretreated patients.[1] The trial is authorised and plans to enroll 327 people.[1]
Melanoma study
2023-507389-15-00 is a phase 2 trial in previously untreated advanced melanoma.[2] It compares RO7198457, named as Autogene Cevumeran in the trial record, plus pembrolizumab versus pembrolizumab alone.[2]
The study is completed and enrolled 130 patients.[2] Its goal is to evaluate both efficacy and safety, and the main outcome is progression-free survival.[2]
Main endpoints measured
The colorectal cancer trial uses disease-free survival (DFS) as its primary outcome.[1] 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.[1]
The melanoma trial uses progression-free survival as its primary outcome.[2] This means the study measures how long patients live without the cancer getting worse.[2]
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.[1] The trial includes people with rectal cancer and colon cancer in the stages listed in the study record.[1]
The melanoma trial is for people with advanced melanoma who have not yet received treatment for that disease.[2] It tests whether adding Autogene Cevumeran to pembrolizumab can improve results compared with pembrolizumab alone.[2]
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.[1][2] The colorectal cancer trial uses watchful waiting as the control, while the melanoma trial uses pembrolizumab alone as the control.[1][2]
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.[1][2]
