Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants will receive a recommended dose of RO7198457.

Observational group will undergo watchful waiting, which is the standard of care in this setting.

RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

RO7198457 intravenous (IV)

Observational group (no intervention)

BioNTech clinical trials patient information

BioNTech Responsible Person

This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.

Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.

A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection

DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

* Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.
* Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment.
* Death from any cause.
* Loss to follow-up is censored.

RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

* Locoregional recurrence or distant metastases as determined by the investigator.
* Death from any cause.
* Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
* Loss to follow-up is censored.

TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first:

* Locoregional recurrence or distant metastases as determined by the investigator.
* Death from same cancer.
* Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
* Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.

TTF is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

* Locoregional recurrence or distant metastases as determined by the investigator.
* Occurrence of second primary (same or other) cancer as determined by the investigator.
* Death from any cause except non-cancer related death.
* Start of new cancer therapy.
* Loss to follow-up and non-cancer-related deaths are censored.

OS defined as the time from randomization to death from any cause.

TEAE, including Grade 3+, serious, fatal TEAE by relationship (adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0).

Spots Global Cancer Trial Database for observational group (no intervention)