Study on the Effectiveness of Autogene Cevumeran in Patients with ctDNA Positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

1

What is this study about?

This clinical trial is focused on studying colorectal cancer, specifically in patients who have undergone surgery for Stage II (high risk) and Stage III colorectal cancer. The study is particularly interested in patients who have a detectable level of circulating tumor DNA (ctDNA) after their surgery. The treatment being tested is called RO7198457 (autogene cevumeran), which is a type of medication given through an injection into the vein. This trial will compare the effects of this treatment to a strategy known as “watchful waiting,” where no immediate treatment is given, and the patient’s condition is closely monitored.

The purpose of the study is to see if RO7198457 (autogene cevumeran) can improve the time patients remain free from cancer after surgery, compared to watchful waiting. Participants in the study will be randomly assigned to receive either the treatment or to be in the watchful waiting group. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and any changes in their cancer status.

Throughout the study, the main focus will be on measuring how long patients remain free from cancer, known as disease-free survival (DFS). Other aspects being observed include the time until cancer returns, overall survival, and any side effects from the treatment. The study aims to provide valuable information on whether RO7198457 (autogene cevumeran) can offer a better outcome for patients with this type of cancer.

1 Joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required to confirm understanding and willingness to participate.

Eligibility criteria include being at least 18 years old, having resected Stage II (high risk) or Stage III colorectal cancer, and detectable ctDNA prior to starting chemotherapy.

2 Randomization

The patient will be randomly assigned to one of two groups: receiving the medication RO7198457 or undergoing watchful waiting.

Randomization ensures that each participant has an equal chance of being assigned to either group.

3 Medication administration

For those receiving RO7198457, the medication is administered as an intravenous injection. The form is a concentrate for solution for injection.

The frequency and duration of administration will be specified by the study protocol.

4 Monitoring and assessments

Regular monitoring will occur to assess the patient’s health and response to treatment. This includes checking for disease-free survival (DFS) and relapse-free survival (RFS).

Assessments will also track any treatment-emergent adverse events (TEAEs) and changes in ctDNA status approximately every three months.

5 Completion of the trial

The trial is estimated to end by November 14, 2028. Upon completion, the patient’s overall survival (OS) and any changes in health status will be evaluated.

The study aims to demonstrate the superiority of RO7198457 compared to watchful waiting in terms of DFS.

Who Can Join the Study?

  • Patients must be a man or woman of at least 18 years of age.
  • Patients must be willing and able to follow the rules specified in the study plan.
  • Enough tumor material must be available, either in special blocks or as tissue sections, and should be submitted with a pathology report.
  • At least 5 tumor neoantigens must be identified in the provided tumor sample. Neoantigens are new markers found on cancer cells.
  • The patient must have started standard chemotherapy within 8 weeks after surgery and completed at least 3 months of treatment.
  • Patients must have given informed consent, meaning they understand the purpose and procedures of the trial and agree to participate.
  • Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer that has been completely removed by surgery.
  • Patients must have detectable ctDNA before starting additional chemotherapy. ctDNA is a type of DNA from cancer cells found in the blood.
  • Patients must have an ECOG Performance Status of 0-1, which means they are fully active or have some symptoms but do not need bed rest.
  • Patients must have proper organ and bone marrow function, meeting specific blood and health criteria.
  • Women must either not be able to have children or use a highly effective birth control method during the trial and for 28 days after the last dose of the study drug.
  • Women who can have children must have a negative pregnancy test before starting the trial.
  • Men who are sexually active with women who can have children and have not had a vasectomy must agree to use a highly effective birth control method during the trial and for 28 days after the last dose of the study drug.

Who Cannot Join the Study?

  • Patients with medical conditions other than Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer cannot participate.
  • Patients who have not been pretreated with chemotherapy are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups are excluded.
  • Patients who are not male or female are excluded, as the study includes both genders.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Katholisches Klinikum Bochum gGmbH Bochum Germany
Grand Hopital De Charleroi Charleroi Belgium
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Hospital Universitario Ramon Y Cajal Madrid Spain
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Hospital Unviersitario Miguel Servet Zaragoza Spain
Hospital Universitario Reina Sofía Cordoba Spain
Hospital Universitario de Ourense Ourense Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Karolinska University Hospital Solna Sweden
Philipps-Universitaet Marburg Marburg Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Gasthuiszusters Antwerpen Antwerp Belgium
Muenchen Klinik gGmbH Munich Germany
Hospital Nuestra Senora De Sonsoles Avila Spain
Hospital Alvaro Cunqueiro Vigo Spain
CHU Helora La Louviere Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Soedersjukhuset AB Stockholm Sweden
Ceqtkkqie Urzcoutcqgskkq Scnwkqwmv Woluwe-Saint-Lambert Belgium
Hrxfdayn Ubkfvnoepenyj Mwkjbtd Dg Veljqshlfn Santander Spain
Inqoux Bonheiden Belgium
Skcxdctvgrrzaeigz Pyfcrgmp glnfu Recklinghausen Germany
Aajya Kdklowybhinwygeshjbnnpr Ogjdbuxrzkk mom Oldenburg In Holstein Germany
Htqrzexn Ubtbscbogefpr Rshngako Dk Murpqj Malaga Spain
Gmjplh Ufbkiyweqd Fyebxpzpa Frankfurt Germany
Kbojcxfs djg Ukonvitzmufn Mbkwasel Awv Munich Germany
Ugfxcqximcuknqjwgcrap Wakqfnhsl Ane Wuerzburg Germany
Hlyegkhf Do Ls Shahw Ciqo I Sokg Phq Barcelona Spain
Uvesarwiqu Mojxjlb Cixiot Hdpararcmsjfgkiwt Hamburg Germany
Ibduwakl Cstrlj Dafnyzblbyxlaonhm L'hospitalet De Llobregat Spain
Flurjdqqk Pplz Lv Ipblydqzktdkk Bpoiqyach Dxr Hcduaecf Ubanvkrbvnmle Lp Pvk Madrid Spain
Hiniliqu Vtpu dyppzazf Barcelona Spain
Hewntydb Uceklicztafhk ds A Cyracq A Coruna Galicia Spain
Savvfugtujdbuvjwznl Bgd Ue (pmmrqsqizwaajbluvvbf Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.04.2024
Germany Germany
Not recruiting
22.04.2024
Spain Spain
Not recruiting
22.04.2024
Sweden Sweden
Not recruiting
22.04.2024

Trial locations

Investigated drugs:

RO7198457 is an investigational medication being studied for its potential to improve outcomes in patients with colorectal cancer. It is being tested to see if it can help prevent the cancer from returning after surgery in patients who have a high risk of recurrence. The trial is comparing the effects of this medication to a strategy of “watchful waiting,” where no active treatment is given, to see if it can extend the time patients remain free of cancer.

Investigated diseases:

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer is often categorized into stages, with Stage II and III indicating more advanced local spread but not distant metastasis.

Colon Cancer – Colon cancer originates in the colon, which is part of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease advances, it can grow through the wall of the colon and spread to nearby lymph nodes and other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and persistent abdominal discomfort. High-risk Stage II and Stage III colon cancer indicate more extensive local spread, with Stage III involving lymph node involvement.

Trial ID:
2023-509516-28-00
Protocol code:
BNT122-01
NCT ID:
NCT04486378
Trial Phase:
Therapeutic exploratory (Phase II)

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