Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04486378 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 327
- Enrollment target
- 20
- Study locations
NCT04486378: Recruiting Phase 2 study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, sponsored by BioNTech SE.
NCT04486378 is a Phase 2 study of Colorectal Cancer Stage II and Colorectal Cancer Stage III that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 327 participants, below the 1,043-participant average among 6 other Colorectal Cancer Stage II trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486378, a Phase 2 study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 327 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG RO7198457 intravenous (IV)
- OTHER Observational group (no intervention)
Study Locations (20)
California
- John Muir Clinical Research Center - Concord
- The Oncology Institute of Hope and Innovation - Glendale
- Marin Cancer Care - Greenbrae
- St Joseph Hospital of Orange - Orange
- Sansum Clinic - Santa Barbara
Florida
- Boca Raton Regional Hospital - Boca Raton
- Florida Cancer Specialist South - Fort Myers
- Mayo Clinic Florida - Jacksonville
- Florida Cancer Specialists - West Palm Beach
Minnesota
- Allina Health - Minneapolis
- Mayo Clinic Rochester - Rochester
New York
- New York Oncology Hematology, P.C. - Albany
- Weill Cornell Medical College - New York
Arizona
- Mayo Clinic - Scottsdale - Scottsdale
Colorado
- Rocky Mountain Cancer Centers - Denver Midtwon - Denver
Illinois
- Cancer Care Center of Decatur, Cancer Care Specialists of IL - Decatur
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
What NCT04486378 shows while recruiting
NCT04486378 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, below the 1,043-participant average among 6 other Colorectal Cancer Stage II trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Colorectal Cancer Stage II appearing as the primary indexed condition, and to 2 interventions - of which RO7198457 intravenous (IV) is the first listed.
NCT04486378 names 20 study sites across 11 states, led by California, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04486378 about?
NCT04486378 is a clinical study titled "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". 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.
What is the current status of trial NCT04486378?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 327 participants. The study started on 2021-03-08. Estimated completion is 2030-08.
What conditions does trial NCT04486378 study?
This clinical trial studies the following conditions: Colorectal Cancer Stage II, Colorectal Cancer Stage III.
What interventions are being tested in trial NCT04486378?
The interventions under investigation include: RO7198457 intravenous (IV) (DRUG), Observational group (no intervention) (OTHER).
Who is sponsoring clinical trial NCT04486378?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04486378 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer Stage II
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Early Onset Colorectal Cancer Detection
RECRUITING
-
Stage II/III Colorectal Cancer Recurrence
RECRUITING
-
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
RECRUITING · Phase 3
-
Splicing-based Predictive Learning for Individual Chemotherapy Evaluation in Colorectal Cancer
RECRUITING
-
Early Detection of Advanced Adenomas and Colorectal Cancer
RECRUITING
-
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
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06370182 · 327 participants · NA
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
- NCT05156983 · 328 participants · Phase 3
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
- NCT05380401 · 328 participants · NA
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
- NCT05548413 · 328 participants · NA
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI