A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus

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

Colorectal Cancer Stage III Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04486378
Study type	Interventional
Source	BioNTech SE
Contact	BioNTech clinical trials patient information
Phone	+49 6131 9084
Email	patients@biontech.de
Status	Recruiting
Phase	Phase 2
Start date	March 8, 2021
Completion date	July 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01570452` - Matrilysin Expression in Different Stages of Colorectal Tumors	N/A
Active, not recruiting	`NCT04304209` - Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer	Phase 2
Active, not recruiting	`NCT04398446` - Effect of Hemp-CBD on Patients With CIPN	Phase 2
Recruiting	`NCT04264676` - Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer	Phase 2
Recruiting	`NCT06314958` - Stage II/III Colorectal Cancer Recurrence
Recruiting	`NCT06342440` - Early Detection of Advanced Adenomas and Colorectal Cancer
Recruiting	`NCT04714814` - Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
Recruiting	`NCT05898789` - Virtual Rehabilitation for Cancer Survivors	N/A
Completed	`NCT01356264` - Multimodal Prehabilitation for Colorectal Surgery	Phase 2
Recruiting	`NCT04813627` - Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
Recruiting	`NCT03448549` - SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients	Phase 3
Recruiting	`NCT03904537` - A Study of Combination of Anti-PD1 Antibody-activated TILs and Chemotherapy in Colorectal Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT05131243` - the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer	N/A
Recruiting	`NCT06076811` - DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Recruiting	`NCT06111105` - Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer
Recruiting	`NCT06342401` - Early Onset Colorectal Cancer Detection
Completed	`NCT06271980` - Early-Onset Colorectal Cancer Recurrence