RECRUITING

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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Conditions

Colorectal Cancer Stage IIColorectal Cancer Stage IIICancerColorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-03-08
Study Completion:2030-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04486378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be a man or woman of at least 18 years of age.
  2. * 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:
  3. * T4
  4. * Grade ≥ 3.
  5. * Clinical presentation with bowel obstruction or perforation.
  6. * Histological signs of vascular, lymphatic or perineural invasion.
  7. * \< 12 nodes evaluated after surgery.
  8. * 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.
  9. * 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.
  10. * Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort).
  11. * ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol.
  12. * Patients must have an Eastern Cooperative Oncology Group Performance Status of 0-1.
  13. * Patients must have adequate hematologic, bone marrow and organ function as defined by the protocol.
  14. * 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.
  15. * At least 5 tumor neoantigens identified in the provided tumor sample.
  16. * 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.
  1. * Patients with uncontrolled intercurrent illness as defined by the protocol.
  2. * Diagnosed microsatellite instability high tumors.
  3. * Prior therapy with any of the following:
  4. * Neo-adjuvant (radio)chemotherapy prior to surgery.
  5. * 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).
  6. * Current or recent (within the 28 days prior to randomization) treatment with another investigational drug.
  7. * Exception for the CLM Cohort: primary tumor must be resected and (neo-)adjuvant chemotherapy prior to curative-intent hepatectomy is accepted.
  8. * 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.
  9. * Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for the Exploratory Cohort or the Biomarker Cohort).
  10. * Patients with known past or current malignancy other than inclusion diagnosis, except for:
  11. * Cervical carcinoma of Stage 1B or less.
  12. * Non-invasive basal cell or squamous cell skin carcinoma.
  13. * Non-invasive, superficial bladder cancer.
  14. * Prostate cancer with a current prostate-specific antigen level \< 0.1 ng/mL.
  15. * Any curable cancer with a complete response of \> 2 years duration.
  16. * Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients.
  17. * 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.
  18. * Patients with positive serology for hepatitis B indicative of active hepatitis B infection:
  19. * Positive test for hepatitis B surface antigen (HBsAg) OR
  20. * 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.
  21. * 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.
  22. * Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
  23. * Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
  24. * Patients who have had prior splenectomy.

Contacts and Locations

Study Contact

BioNTech clinical trials patient information
CONTACT
+49 6131 9084
patients@biontech.de

Principal Investigator

BioNTech Responsible Person
STUDY_DIRECTOR
BioNTech SE

Study Locations (Sites)

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
Allina Health
Minneapolis, Minnesota, 55407
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

Collaborators and Investigators

Sponsor: BioNTech SE

  • BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-08
Study Completion Date2030-08

Study Record Updates

Study Start Date2021-03-08
Study Completion Date2030-08

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Colorectal Cancer

Additional Relevant MeSH Terms

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III