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.

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Full Description

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

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 American Joint Committee on Cancer 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 evaluated after surgery.

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 Performance Status of 0-1.
Patients must have adequate hematologic, bone marrow and organ function as defined by the protocol.
Adequate tumor material in formalin-fixed paraffin embedded 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 preferably within 8 weeks but no later than 10 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 as defined by the protocol.
Diagnosed microsatellite instability 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 prostate-specific antigen level < 0.1 ng/mL.
Any curable cancer with a complete response 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 positive serology for hepatitis B (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy):

Based on a test for antibodies to hepatitis B core antigens (anti-HBc) and
Negative test for antibodies to hepatitis B surface antigens (anti-HBs).
Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
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.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

229

Study ID:

NCT04486378

Recruitment Status:

Recruiting

Sponsor:

BioNTech SE

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There are 110 Locations for this study

See Locations Near You

Mayo Clinic - Scottsdale
Scottsdale Arizona, 85259, United States
John Muir Clinical Research Center
Concord California, 94520, United States
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
Sansum Clinic
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Centers - Denver Midtwon
Denver Colorado, 80218, United States
Florida Cancer Specialist South
Fort Myers Florida, 33916, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, 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
Indiana University Melvin and Bren Simon Comprehensive Cancer
Indianapolis Indiana, 46202, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
University of Louisville - James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Josephine Ford Cancer Center-Henry Ford Cancer Center
Detroit Michigan, 48202, United States
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
Weill Cornell Medical College
New York New York, 10021, United States
New York - Presbyterian Hospital - Columbia University Medical center
New York New York, 10032, United States
Mayo Clinic Rochester
Rochester New York, 55905, United States
Oncology Hematology Care Clinical Trials
Cincinnati Ohio, 45245, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Rhode Island Hospital
Providence Rhode Island, 02906, United States
Hollings Cancer Center Medical University Of South Carolina
Charleston South Carolina, 29425, United States
Sarah Cannon (Tennessee Oncology - Nashville
Nashville Tennessee, 37203, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville Tennessee, 37203, United States
Texas Oncology, P.A. - Austin
Austin Texas, 78705, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology-San Antonio Medical Center
San Antonio Texas, 78240, United States
Texas Oncology - Northeast Texas
Tyler Texas, 75702, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Benaroya Research Institute at Virginia Mason
Seattle Washington, 98101, United States
University of Washington
Seattle Washington, 98109, United States
MultiCare Institute for Research & Innovation
Spokane Washington, 99218, United States
Northwest Cancer Specialists P.C.
Vancouver Washington, 98684, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Imeldaziekenhuis General Hospital
Bonheiden , 2820, Belgium
VZW Algemeen Ziekenhuis AZ Klina
Brasschaat , 2930, Belgium
Institut Jules Bordet
Brussel , 1070, 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
AZ Delta Roeselare
Roeselare , 8800, Belgium
GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk , 2610, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert , 1200, Belgium
Charité - Universitätsmedizin Berlin
Berlin , 10117, Germany
Universitaetsklinikum St. Josef-Hospital Bochum
Bochum , 44791, Germany
Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I
Bonn , 53105, Germany
Klinikum Esslingen GmbH
Esslingen , 73730, 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
Studiengesellschaft BSF
Halle , 06108, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany
Hämatologisch-Onkologische Praxis Eppendorf
Hamburg , 20249, 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
Klinikum der Philipps-Universität Marburg
Marburg , 35043, Germany
LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München
München , 81377, Germany
Städtisches Klinikum München GmbH, Klinikum Neuperlach
München , 81737, Germany
OhO Ostholstein Onkologie
Oldenburg In Holstein , 23758, Germany
Prosper Hospital
Recklinghausen , 45659, Germany
Robert-Bosch-Krankenhaus - Centrum fuer Tumorerkrankungen
Stuttgart , 70376, Germany
Universitätsklinikum Ulm
Ulm , 89081, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Complejo Hospitalario Universitario A Coruna
A Coruna , 15006, Spain
Hospital Nuestra Senora de Sonsoles
Avila , 05004, 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 Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)
Madrid , 28050, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda , 28222, Spain
Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga
Málaga , 29011, Spain
Complejo Hospitalario de Orense
Orense , 32005, Spain
Clinica Universitaria de Navarra
Pamplona , 31008, Spain
Complejo Hospitalario de Navarra (CHN)
Pamplona , 31008, Spain
Hospital Universitario Marques De Valdecilla
Santander , 39008, Spain
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago De Compostela , 15706, Spain
Hospital Universitario Virgen del Rocio - Hospital de la Mujer
Sevilla , 41013, Spain
Consorcio Hospital General Valencia
Valencia , 46014, Spain
Complexo Hospitalario Universitario de Vigo (CHUVI)
Vigo , 36312, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
Lund , 221 0, Sweden
Sodersjukhuset, Onkologiska Kliniken
Stockholm , 11883, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm , 17176, Sweden
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington , CH63 , United Kingdom
Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust
Birmingham , B15 2, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff , CF14 , United Kingdom
Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde
Glasgow , G12 0, United Kingdom
St Bartholomew's Hospital-Barts Health NHS Trust
London , EC1A , United Kingdom
University College London Hospitals NHS Foundation Trust
London , NW2 1, United Kingdom
Royal Free London NHS Foundation Trust
London , NW3 2, United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust
London , SE1 7, United Kingdom
The Royal Marsden NHS Foundation Trust- Chelsea
London , SW3 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston , PR2 9, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , SM25N, United Kingdom
Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge
Torquay , TQ2 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

229

Study ID:

NCT04486378

Recruitment Status:

Recruiting

Sponsor:


BioNTech SE

How clear is this clinincal trial information?

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