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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04486378
The ClinicalTrials.gov registry entry for NCT04486378 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 327 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,043-participant average among 6 other Colorectal Cancer Stage II trials with a reported enrollment target (69% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Related
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