Colon Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must be a man or woman of at least 18 years of age.

Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as Stage II disease with any of the following risk factors for recurrence:

T4
Grade ≥ 3.
Clinical presentation with bowel obstruction or perforation.
Histological signs of vascular, lymphatic or perineural invasion.
< 12 nodes examined.

Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort).

• ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol.

Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Patients must have adequate hematologic and organ function.
Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as sectioned tissue (only upon approval by sponsor) must be available (as described in the laboratory manual).
The patient has started a standard of care AdCTx within 8 weeks post-surgery and has completed at least 3 months of treatment of a 3 or a 6 month course of chemotherapy (including rest days).

Exclusion Criteria:

Patients with uncontrolled intercurrent illness.
Diagnosed microsatellite instability (MSI) high tumors.

Prior therapy with any of the following:

Neo-adjuvant (radio)chemotherapy prior to surgery.
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of trial treatment or anticipation of need for systemic immunosuppressive medication during trial treatment, with the exception of low dose steroids defined as 10 mg oral prednisone (or equivalent).
Current or recent (within the 28 days prior to randomization) treatment with another investigational drug.
Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for Exploratory Cohort).

Patients with known past or current malignancy other than inclusion diagnosis, except for:

Cervical carcinoma of Stage 1B or less.
Non-invasive basal cell or squamous cell skin carcinoma.
Non-invasive, superficial bladder cancer.
Prostate cancer with a current PSA level < 0.1 ng/mL.
Any curable cancer with a complete response (CR) of > 2 years duration.
Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients.
Patients who had major surgery (e.g., surgery requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or have surgery planned during the time the patient are expected to participate in the trial.
Patients with active hepatitis B or C.
Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
Patients who have had prior splenectomy.

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

201

Study ID:

NCT04486378

Recruitment Status:

Recruiting

Sponsor:

BioNTech SE

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There are 46 Locations for this study

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The Oncology Institute of Hope and Innovation
Glendale California, 91204, United States
Marin Cancer Care
Greenbrae California, 94904, United States
St Joseph Hospital of Orange
Orange California, 92868, United States
Florida Cancer Specialist South
Fort Myers Florida, 33916, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Cancer Care Center of Decatur, Cancer Care Specialists of IL
Decatur Illinois, 62526, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Josephine Ford Cancer Center-Henry Ford Cancer Center
Detroit Michigan, 48202, United States
Sarah Cannon (Tennessee Oncology - Nashville
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
MultiCare Institute for Research & Innovation
Spokane Washington, 99218, United States
VZW Algemeen Ziekenhuis AZ Klina
Brasschaat , 2930, Belgium
GHDC (Grand Hopital de Charleroi)
Charleroi , 6000, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
Centres Hospitaliers Jolimont
La Louviere , 7100, Belgium
Universitaire Ziekenhuizen Leuven
Leuven , 3000, Belgium
Charité - Universitätsmedizin Berlin
Berlin , 10117, Germany
Universitaetsklinikum St. Josef-Hospital Bochum
Bochum , 44791, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt am Main , 60488, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Frankfurt am Main , 60590, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
National Center for Tumor Diseases (NCT) Heidelberg
Heidelberg , 69120, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn , 74078, Germany
Staedtisches Krankenhaus Kiel gGmbH
Kiel , 24116, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig , 04103, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz , 55131, Germany
LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München
München , 81377, Germany
Prosper Hospital
Recklinghausen , 45659, Germany
Complejo Hospitalario Universitario A Coruna
A Coruna , 15006, Spain
Hospital Universitari Germans Trias - ICO Badalona
Badalona , 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona
Barcelona , 8036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 8041, Spain
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Clinica Universidad Navarra
Madrid , 28027, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)
Madrid , 28050, Spain
Complejo Hospitalario de Orense
Orense , 32005, Spain
Clinica Universitaria de Navarra
Pamplona , 31008, Spain
Hospital Universitario Marques De Valdecilla
Santander , 39008, Spain
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago De Compostela , 15706, Spain
Consorcio Hospital General Valencia
Valencia , 46014, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

201

Study ID:

NCT04486378

Recruitment Status:

Recruiting

Sponsor:


BioNTech SE

How clear is this clinincal trial information?

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