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ACTIVE NOT RECRUITING

NCT04486378

PHASE2

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

327

Start Date

2021-03-08

Completion Date

2030-08

Last Updated

2026-05-14

Healthy Volunteers

Conditions

Colorectal Cancer Stage II Colorectal Cancer Stage III

Interventions

DRUG

RO7198457 intravenous (IV)

RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

OTHER

Observational group (no intervention)

watchful waiting

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 (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. 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. * Exception for the CLM Cohort: primary tumor must be resected and (neo-)adjuvant chemotherapy prior to curative-intent hepatectomy is accepted. * 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 the Exploratory Cohort or the Biomarker 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 indicative of active hepatitis B infection: * Positive test for hepatitis B surface antigen (HBsAg) OR * Negative test for HBsAg AND positive test for antibodies to hepatitis B core antigens (anti-HBc) AND positive test for hepatitis B virus (HBV) DNA. * Serological markers indicative of vaccination (isolated antibodies to hepatitis B surface antigens \[anti-HBs\]) or resolved natural infection without viral load (anti-HBc with negative HBsAg and negative HBV DNA) are not exclusionary. * 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.

Locations (90)

John Muir Clinical Research Center

Concord, California, United States

Marin Cancer Care

Greenbrae, California, United States

Rocky Mountain Cancer Centers - Denver Midtwon

Denver, Colorado, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer

Indianapolis, Indiana, United States

Allina Health

Minneapolis, Minnesota, United States

Oncology Hematology Care Clinical Trials

Cincinnati, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Sarah Cannon (Tennessee Oncology - Nashville)

Nashville, Tennessee, United States

Texas Oncology, P.A. - Austin

Austin, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology-San Antonio Medical Center

San Antonio, Texas, United States

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

University of Washington

Seattle, Washington, United States

Northwest Cancer Specialists P.C.

Vancouver, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Imeldaziekenhuis General Hospital

Bonheiden, Belgium

VZW Algemeen Ziekenhuis AZ Klina

Brasschaat, Belgium

GHDC (Grand Hopital de Charleroi)

Charleroi, Belgium

AZ Groeninge

Kortrijk, Belgium

Centres Hospitaliers Jolimont

La Louvière, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

AZ Delta Roeselare

Roeselare, Belgium

GasthuisZusters Antwerpen - Sint-Augustinus

Wilrijk, Belgium

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

The Ottawa Hospital Cancer Centre

Ottawa, Canada

Princess Margaret Cancer Centre

Toronto, Canada

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitaetsklinikum St. Josef-Hospital Bochum

Bochum, Germany

Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I

Bonn, Germany

Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)

Frankfurt am Main, Germany

Studiengesellschaft BSF

Halle, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Hämatologisch-Onkologische Praxis Eppendorf

Hamburg, Germany

Asklepios Klinik Altona

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

National Center for Tumor Diseases (NCT) Heidelberg

Heidelberg, Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Universitaetsklinikum Leipzig AoeR

Leipzig, Germany

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

Mainz, Germany

Klinikum der Philipps-Universität Marburg

Marburg, Germany

LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München

München, Germany

Städtisches Klinikum München GmbH, Klinikum Neuperlach

München, Germany

OhO Ostholstein Onkologie

Oldenburg in Holstein, Germany

Prosper Hospital

Recklinghausen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital Nuestra Senora de Sonsoles

Ávila, Spain

Hospital Universitari Germans Trias - ICO Badalona

Badalona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga

Málaga, Spain

Complejo Hospitalario de Orense

Ourense, Spain

Clinica Universitaria de Navarra

Pamplona, Spain

Complejo Hospitalario de Navarra (CHN)

Pamplona, Spain

Hospital Universitario Marques De Valdecilla

Santander, Spain

Complejo Hospitalario Universitario De Santiago De Compostela

Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocio - Hospital de la Mujer

Seville, Spain

Consorcio Hospital General Valencia

Valencia, Spain

Complexo Hospitalario Universitario de Vigo (CHUVI)

Vigo, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)

Lund, Sweden

Sodersjukhuset, Onkologiska Kliniken

Stockholm, Sweden

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, United Kingdom

Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Velindre NHS Trust, Velindre Cancer Centre

Cardiff, United Kingdom

Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

Cottingham, United Kingdom

Dorset County Hospital NHS Foundation Trust - Dorset County Hospital

Dorchester, United Kingdom

Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

St Bartholomew's Hospital-Barts Health NHS Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Guy's and St Thomas' Hospital NHS Foundation Trust

London, United Kingdom

The Royal Marsden NHS Foundation Trust- Chelsea

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, United Kingdom

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge

Torquay, United Kingdom

Clinical Research Directory

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

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (90)