Back to resultsA 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
Primary Purpose
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RO7198457 intravenous (i.v.)
Observational group (no intervention)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Stage II focused on measuring Cancer, Colorectal Cancer
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.
Sites / Locations
- Mayo Clinic - ScottsdaleRecruiting
- John Muir Clinical Research CenterRecruiting
- The Oncology Institute of Hope and InnovationRecruiting
- Marin Cancer CareRecruiting
- St Joseph Hospital of OrangeRecruiting
- Sansum ClinicRecruiting
- Florida Cancer Specialist SouthRecruiting
- Mayo Clinic FloridaRecruiting
- Florida Cancer SpecialistsRecruiting
- Cancer Care Center of Decatur, Cancer Care Specialists of ILRecruiting
- Indiana University Melvin and Bren Simon Comprehensive CancerRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Louisville - James Graham Brown Cancer CenterRecruiting
- Josephine Ford Cancer Center-Henry Ford Cancer CenterRecruiting
- New York Oncology Hematology, P.C.Recruiting
- New York - Presbyterian Hospital - Columbia University Medical centerRecruiting
- Mayo Clinic RochesterRecruiting
- Oncology Hematology Care Clinical TrialsRecruiting
- Willamette Valley Cancer Institute and Research CenterRecruiting
- Sarah Cannon (Tennessee Oncology - NashvilleRecruiting
- Texas Oncology, P.A. - AustinRecruiting
- Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- Texas Oncology-San Antonio Medical CenterRecruiting
- Texas Oncology - Northeast TexasRecruiting
- Virginia Cancer SpecialistsRecruiting
- Benaroya Research Institute at Virginia MasonRecruiting
- University of WashingtonRecruiting
- MultiCare Institute for Research & InnovationRecruiting
- Northwest Cancer Specialists P.C.Recruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Imeldaziekenhuis General HospitalRecruiting
- VZW Algemeen Ziekenhuis AZ KlinaRecruiting
- Institut Jules BordetRecruiting
- GHDC (Grand Hopital de Charleroi)Recruiting
- AZ GroeningeRecruiting
- Centres Hospitaliers JolimontRecruiting
- Universitaire Ziekenhuizen LeuvenRecruiting
- AZ Delta RoeselareRecruiting
- GasthuisZusters Antwerpen - Sint-AugustinusRecruiting
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-LucRecruiting
- Charité - Universitätsmedizin BerlinRecruiting
- Universitaetsklinikum St. Josef-Hospital BochumRecruiting
- Universitätsklinikum Bonn, Med. Klinik u. Poliklinik IRecruiting
- Klinikum Esslingen GmbHRecruiting
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)Recruiting
- Klinikum der Johann Wolfgang Goethe-Universitaet FrankfurtRecruiting
- Studiengesellschaft BSFRecruiting
- Universitätsklinikum Hamburg-EppendorfRecruiting
- Hämatologisch-Onkologische Praxis EppendorfRecruiting
- Asklepios Klinik AltonaRecruiting
- Medizinische Hochschule HannoverRecruiting
- National Center for Tumor Diseases (NCT) HeidelbergRecruiting
- SLK-Kliniken Heilbronn GmbHRecruiting
- Staedtisches Krankenhaus Kiel gGmbHRecruiting
- Universitaetsklinikum Leipzig AoeRRecruiting
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeRRecruiting
- Klinikum der Philipps-Universität MarburgRecruiting
- LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität MünchenRecruiting
- Städtisches Klinikum München GmbH, Klinikum NeuperlachRecruiting
- OhO Ostholstein OnkologieRecruiting
- Prosper HospitalRecruiting
- Robert-Bosch-Krankenhaus - Centrum fuer TumorerkrankungenRecruiting
- Universitätsklinikum UlmRecruiting
- Universitätsklinikum WürzburgRecruiting
- Complejo Hospitalario Universitario A CorunaRecruiting
- Hospital Nuestra Senora de SonsolesRecruiting
- Hospital Universitari Germans Trias - ICO BadalonaRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de BarcelonaRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario Reina SofiaRecruiting
- Hospital General Universitario Gregorio MaranonRecruiting
- Clinica Universidad NavarraRecruiting
- Hospital Universitario Ramón y CajalRecruiting
- Hospital Clinico San CarlosRecruiting
- Hospital Universitario Fundacion Jimenez DiazRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)Recruiting
- Hospital Universitario Puerta de Hierro de MajadahondaRecruiting
- Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de MalagaRecruiting
- Complejo Hospitalario de OrenseRecruiting
- Clinica Universitaria de NavarraRecruiting
- Complejo Hospitalario de Navarra (CHN)Recruiting
- Hospital Universitario Marques De ValdecillaRecruiting
- Complejo Hospitalario Universitario De Santiago De CompostelaRecruiting
- Hospital Universitario Virgen del Rocio - Hospital de la MujerRecruiting
- Consorcio Hospital General ValenciaRecruiting
- Complexo Hospitalario Universitario de Vigo (CHUVI)Recruiting
- Hospital Universitario Miguel ServetRecruiting
- Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)Recruiting
- Sodersjukhuset, Onkologiska KlinikenRecruiting
- Karolinska Universitetssjukhuset SolnaRecruiting
- The Clatterbridge Cancer Centre NHS Foundation TrustRecruiting
- Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation TrustRecruiting
- Velindre NHS Trust, Velindre Cancer CentreRecruiting
- St Bartholomew's Hospital-Barts Health NHS TrustRecruiting
- University College London Hospitals NHS Foundation TrustRecruiting
- The Royal Marsden NHS Foundation Trust- ChelseaRecruiting
- The Christie NHS Foundation TrustRecruiting
- The Royal Marsden NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Experimental
Arm Label
RO7198457
Observational Group
Biomarker Cohort
Exploratory Cohort
Arm Description
Participants will receive a recommended dose of RO7198457.
Observational group will undergo watchful waiting, which is the standard of care in this setting.
15 patients
20 patients
Outcomes
Primary Outcome Measures
Disease-free survival (DFS)
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.
Secondary Outcome Measures
Relapse-free survival (RFS)
RFS is 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 the investigator.
Death from any cause.
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
Loss to follow-up is censored.
Time to recurrence (TTR)
TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first:
Locoregional recurrence or distant metastases as determined by the investigator.
Death from same cancer.
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.
Time to treatment failure (TTF)
TTF is 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 the investigator.
Occurrence of second primary (same or other) cancer as determined by the investigator.
Death from any cause except non-cancer related death.
Loss to follow-up and non-cancer-related deaths are censored.
Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Change of Circulating tumor DNA (ctDNA) status (every 3 months)
Occurrence of treatment emergent adverse event (TEAE)
TEAE, including Grade 3+, serious, fatal TEAE by relationship (AEs graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events, version 5.0 [CTCAE v5.0])
Occurrence of dose reduction and discontinuation of IMP due to a TEAE.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486378
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNTech SE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Keywords
Cancer, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RO7198457
Arm Type
Experimental
Arm Description
Participants will receive a recommended dose of RO7198457.
Arm Title
Observational Group
Arm Type
Other
Arm Description
Observational group will undergo watchful waiting, which is the standard of care in this setting.
Arm Title
Biomarker Cohort
Arm Type
Experimental
Arm Description
15 patients
Arm Title
Exploratory Cohort
Arm Type
Experimental
Arm Description
20 patients
Intervention Type
Drug
Intervention Name(s)
RO7198457 intravenous (i.v.)
Intervention Description
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Intervention Type
Other
Intervention Name(s)
Observational group (no intervention)
Intervention Description
watchful waiting
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
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.
Time Frame
Through study completion, up to 5 years
Secondary Outcome Measure Information:
Title
Relapse-free survival (RFS)
Description
RFS is 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 the investigator.
Death from any cause.
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
Loss to follow-up is censored.
Time Frame
Through study completion, up to 5 years
Title
Time to recurrence (TTR)
Description
TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first:
Locoregional recurrence or distant metastases as determined by the investigator.
Death from same cancer.
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.
Time Frame
Through study completion, up to 5 years
Title
Time to treatment failure (TTF)
Description
TTF is 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 the investigator.
Occurrence of second primary (same or other) cancer as determined by the investigator.
Death from any cause except non-cancer related death.
Loss to follow-up and non-cancer-related deaths are censored.
Time Frame
Through study completion, up to 5 years
Title
Overall survival (OS)
Description
OS defined as the time from randomization to death from any cause.
Time Frame
Through study completion, up to 5 years
Title
Change of Circulating tumor DNA (ctDNA) status (every 3 months)
Time Frame
Through study completion, up to 5 years
Title
Occurrence of treatment emergent adverse event (TEAE)
Description
TEAE, including Grade 3+, serious, fatal TEAE by relationship (AEs graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events, version 5.0 [CTCAE v5.0])
Time Frame
15 months
Title
Occurrence of dose reduction and discontinuation of IMP due to a TEAE.
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BioNTech clinical trials patient information
Phone
+49 6131 9084
Ext
0
Email
patients@biontech.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BioNTech Responsible Person
Organizational Affiliation
BioNTech SE
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Name
John Muir Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Recruiting
Facility Name
The Oncology Institute of Hope and Innovation
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Individual Site Status
Recruiting
Facility Name
St Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialist South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Center of Decatur, Cancer Care Specialists of IL
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University Melvin and Bren Simon Comprehensive Cancer
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Louisville - James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Josephine Ford Cancer Center-Henry Ford Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Recruiting
Facility Name
New York - Presbyterian Hospital - Columbia University Medical center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology Care Clinical Trials
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Individual Site Status
Recruiting
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon (Tennessee Oncology - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology, P.A. - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Northeast Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Institute for Research & Innovation
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Cancer Specialists P.C.
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Imeldaziekenhuis General Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Recruiting
Facility Name
VZW Algemeen Ziekenhuis AZ Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Institut Jules Bordet
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GHDC (Grand Hopital de Charleroi)
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centres Hospitaliers Jolimont
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta Roeselare
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GasthuisZusters Antwerpen - Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
City
Woluwe-Saint-Lambert
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum St. Josef-Hospital Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studiengesellschaft BSF
City
Halle
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hämatologisch-Onkologische Praxis Eppendorf
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
National Center for Tumor Diseases (NCT) Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
SLK-Kliniken Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Individual Site Status
Recruiting
Facility Name
Staedtisches Krankenhaus Kiel gGmbH
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig AoeR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Name
LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Städtisches Klinikum München GmbH, Klinikum Neuperlach
City
München
ZIP/Postal Code
81737
Country
Germany
Individual Site Status
Recruiting
Facility Name
OhO Ostholstein Onkologie
City
Oldenburg In Holstein
ZIP/Postal Code
23758
Country
Germany
Individual Site Status
Recruiting
Facility Name
Prosper Hospital
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Individual Site Status
Recruiting
Facility Name
Robert-Bosch-Krankenhaus - Centrum fuer Tumorerkrankungen
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Nuestra Senora de Sonsoles
City
Avila
ZIP/Postal Code
05004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Germans Trias - ICO Badalona
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario de Orense
City
Orense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario de Navarra (CHN)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques De Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario De Santiago De Compostela
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio - Hospital de la Mujer
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Consorcio Hospital General Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario de Vigo (CHUVI)
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
City
Lund
ZIP/Postal Code
221 00
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Sodersjukhuset, Onkologiska Kliniken
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Velindre NHS Trust, Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St Bartholomew's Hospital-Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW2 1PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Foundation Trust- Chelsea
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM25NG
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this 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
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