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

Who is this study for? Adult patients with Stage II or III Rectal Cancer or Colon Cancer
What treatments are being studied? RO7198457
Status: Recruiting
Location: See all (121) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 (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 evaluated after surgery.

• For the CLM Cohort: patients must have metastatic colorectal cancer (mCRC) (Stage IV) with resected CLM (synchronous and metachronous CLM within 6 months of initial diagnosis) per AJCC 2017, after standard of care (SoC) primary resection and curative-intent hepatectomy (R0 confirmed by pathology report) with or without (neo-)adjuvant chemotherapy (prior to hepatectomy), and planned adjuvant chemotherapy.

∙ For the Biomarker Cohort: patients with tumors of the colon, including but not limited to, colon adenocarcinoma, carcinoid tumors (including goblet cell carcinoid/adenocarcinoma), and tumors of the appendix, whose tumors were surgically resected and are planned for adjuvant chemotherapy (per institutional standards), can be included.

• 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). For the CLM Cohort: tumor material must come from primary resection for patients who undergo staged approach, or from available archival material from the previously untreated tumor biopsy from the primary.

• At least 5 tumor neoantigens identified in the provided tumor sample.

• 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). For the CLM Cohort: patient must have completed AdCTx with or without (neo-)adjuvant chemotherapy for up to 6 months in total or total intended amount determined by care providers per SoC. AdCTx must have started preferably within 8 weeks, but no later than 10 weeks, after hepatectomy. For the Biomarker Cohort: patient must have received at least one cycle of adjuvant chemotherapy per institutional standards.

Locations
United States
Arizona
Mayo Clinic - Scottsdale
WITHDRAWN
Scottsdale
California
John Muir Clinical Research Center
RECRUITING
Concord
The Oncology Institute of Hope and Innovation
WITHDRAWN
Glendale
Marin Cancer Care
RECRUITING
Greenbrae
St Joseph Hospital of Orange
WITHDRAWN
Orange
Sansum Clinic
RECRUITING
Santa Barbara
Colorado
Rocky Mountain Cancer Centers - Denver Midtwon
RECRUITING
Denver
Florida
Boca Raton Regional Hospital
WITHDRAWN
Boca Raton
Florida Cancer Specialist South
WITHDRAWN
Fort Myers
Mayo Clinic Florida
WITHDRAWN
Jacksonville
Florida Cancer Specialists
WITHDRAWN
West Palm Beach
Illinois
Cancer Care Center of Decatur, Cancer Care Specialists of IL
RECRUITING
Decatur
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer
RECRUITING
Indianapolis
Kansas
University of Kansas Cancer Center
WITHDRAWN
Westwood
Kentucky
University of Louisville - James Graham Brown Cancer Center
WITHDRAWN
Louisville
Michigan
Josephine Ford Cancer Center-Henry Ford Cancer Center
WITHDRAWN
Detroit
Minnesota
Allina Health
RECRUITING
Minneapolis
Mayo Clinic Rochester
WITHDRAWN
Rochester
New York
New York Oncology Hematology, P.C.
WITHDRAWN
Albany
New York - Presbyterian Hospital - Columbia University Medical center
WITHDRAWN
New York
Weill Cornell Medical College
WITHDRAWN
New York
Ohio
Oncology Hematology Care Clinical Trials
RECRUITING
Cincinnati
Oregon
Willamette Valley Cancer Institute and Research Center
WITHDRAWN
Eugene
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Hollings Cancer Center Medical University Of South Carolina
WITHDRAWN
Charleston
Tennessee
Sarah Cannon (Tennessee Oncology - Nashville
RECRUITING
Nashville
Sarah Cannon Research Institute (SCRI) Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology, P.A. - Austin
RECRUITING
Austin
Texas Oncology-Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology-San Antonio Medical Center
RECRUITING
San Antonio
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Benaroya Research Institute at Virginia Mason
RECRUITING
Seattle
University of Washington
RECRUITING
Seattle
MultiCare Institute for Research & Innovation
WITHDRAWN
Spokane
Northwest Cancer Specialists P.C.
RECRUITING
Vancouver
Wisconsin
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Froedtert Hospital and Medical College of Wisconsin
WITHDRAWN
Milwaukee
Other Locations
Belgium
Imeldaziekenhuis General Hospital
ACTIVE_NOT_RECRUITING
Bonheiden
VZW Algemeen Ziekenhuis AZ Klina
ACTIVE_NOT_RECRUITING
Brasschaat
Institut Jules Bordet
WITHDRAWN
Brussels
GHDC (Grand Hopital de Charleroi)
ACTIVE_NOT_RECRUITING
Charleroi
AZ Groeninge
ACTIVE_NOT_RECRUITING
Kortrijk
Centres Hospitaliers Jolimont
ACTIVE_NOT_RECRUITING
La Louvière
Universitaire Ziekenhuizen Leuven
ACTIVE_NOT_RECRUITING
Leuven
AZ Delta Roeselare
ACTIVE_NOT_RECRUITING
Roeselare
GasthuisZusters Antwerpen - Sint-Augustinus
ACTIVE_NOT_RECRUITING
Wilrijk
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
ACTIVE_NOT_RECRUITING
Woluwe-saint-lambert
Canada
The Ottawa Hospital Cancer Centre
ACTIVE_NOT_RECRUITING
Ottawa
Princess Margaret Cancer Centre
ACTIVE_NOT_RECRUITING
Toronto
Germany
Charité - Universitätsmedizin Berlin
ACTIVE_NOT_RECRUITING
Berlin
Universitaetsklinikum St. Josef-Hospital Bochum
ACTIVE_NOT_RECRUITING
Bochum
Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I
ACTIVE_NOT_RECRUITING
Bonn
Klinikum Esslingen GmbH
ACTIVE_NOT_RECRUITING
Esslingen Am Neckar
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Studiengesellschaft BSF
ACTIVE_NOT_RECRUITING
Halle
Asklepios Klinik Altona
ACTIVE_NOT_RECRUITING
Hamburg
Hämatologisch-Onkologische Praxis Eppendorf
ACTIVE_NOT_RECRUITING
Hamburg
Universitätsklinikum Hamburg-Eppendorf
ACTIVE_NOT_RECRUITING
Hamburg
Medizinische Hochschule Hannover
ACTIVE_NOT_RECRUITING
Hanover
National Center for Tumor Diseases (NCT) Heidelberg
ACTIVE_NOT_RECRUITING
Heidelberg
SLK-Kliniken Heilbronn GmbH
ACTIVE_NOT_RECRUITING
Heilbronn
Staedtisches Krankenhaus Kiel gGmbH
ACTIVE_NOT_RECRUITING
Kiel
Universitaetsklinikum Leipzig AoeR
ACTIVE_NOT_RECRUITING
Leipzig
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
ACTIVE_NOT_RECRUITING
Mainz
Klinikum der Philipps-Universität Marburg
ACTIVE_NOT_RECRUITING
Marburg
LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München
ACTIVE_NOT_RECRUITING
München
Städtisches Klinikum München GmbH, Klinikum Neuperlach
ACTIVE_NOT_RECRUITING
München
OhO Ostholstein Onkologie
ACTIVE_NOT_RECRUITING
Oldenburg In Holstein
Prosper Hospital
ACTIVE_NOT_RECRUITING
Recklinghausen
Robert-Bosch-Krankenhaus - Centrum fuer Tumorerkrankungen
ACTIVE_NOT_RECRUITING
Stuttgart
Universitätsklinikum Ulm
ACTIVE_NOT_RECRUITING
Ulm
Universitätsklinikum Würzburg
ACTIVE_NOT_RECRUITING
Würzburg
Spain
Complejo Hospitalario Universitario A Coruna
ACTIVE_NOT_RECRUITING
A Coruña
Hospital Nuestra Senora de Sonsoles
ACTIVE_NOT_RECRUITING
Ávila
Hospital Universitari Germans Trias - ICO Badalona
ACTIVE_NOT_RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
ACTIVE_NOT_RECRUITING
Córdoba
Clinica Universidad Navarra
ACTIVE_NOT_RECRUITING
Madrid
Hospital Clinico San Carlos
ACTIVE_NOT_RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
ACTIVE_NOT_RECRUITING
Majadahonda
Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga
ACTIVE_NOT_RECRUITING
Málaga
Complejo Hospitalario de Orense
ACTIVE_NOT_RECRUITING
Ourense
Clinica Universitaria de Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Complejo Hospitalario de Navarra (CHN)
ACTIVE_NOT_RECRUITING
Pamplona
Hospital Universitario Marques De Valdecilla
ACTIVE_NOT_RECRUITING
Santander
Complejo Hospitalario Universitario De Santiago De Compostela
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio - Hospital de la Mujer
ACTIVE_NOT_RECRUITING
Seville
Consorcio Hospital General Valencia
ACTIVE_NOT_RECRUITING
Valencia
Complexo Hospitalario Universitario de Vigo (CHUVI)
ACTIVE_NOT_RECRUITING
Vigo
Hospital Universitario Miguel Servet
ACTIVE_NOT_RECRUITING
Zaragoza
Sweden
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
ACTIVE_NOT_RECRUITING
Lund
Karolinska Universitetssjukhuset Solna
ACTIVE_NOT_RECRUITING
Stockholm
Sodersjukhuset, Onkologiska Kliniken
ACTIVE_NOT_RECRUITING
Stockholm
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING
Bebington
Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Velindre NHS Trust, Velindre Cancer Centre
RECRUITING
Cardiff
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
RECRUITING
Cottingham
Dorset County Hospital NHS Foundation Trust - Dorset County Hospital
ACTIVE_NOT_RECRUITING
Dorchester
Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
Guy's and St Thomas' Hospital NHS Foundation Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
St Bartholomew's Hospital-Barts Health NHS Trust
RECRUITING
London
The Royal Marsden NHS Foundation Trust- Chelsea
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Manchester
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
RECRUITING
Preston
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
RECRUITING
Southampton
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge
RECRUITING
Torquay
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2021-03-08
Estimated Completion Date: 2030-08
Participants
Target number of participants: 327
Treatments
Experimental: RO7198457
Participants will receive a recommended dose of RO7198457.
Other: Observational Group
Observational group will undergo watchful waiting, which is the standard of care in this setting.
Experimental: Biomarker Cohort
Experimental: Exploratory Cohort
Experimental: Colorectal Liver Metastasis (CLM) Cohort
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov