Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

• ClinicalTrials.gov Identifier: NCT03765736
• Recruitment Status: Recruiting
• First Posted: December 5, 2018
• Last Update Posted: May 11, 2023
• Sponsor: Academic and Community Cancer Research United
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Academic and Community Cancer Research United

Tracking Information

• First Submitted Date: December 4, 2018
• First Posted Date: December 5, 2018
• Last Update Posted Date: May 11, 2023
• Actual Study Start Date: April 20, 2020
• Estimated Primary Completion Date: November 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2021)

• The proportion of patients who have an actionable genomic profile [ Time Frame: Up to 5 years ]
  This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
• Companion trial enrollment [ Time Frame: Up to 5 years ]
  This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).

Original Primary Outcome Measures (submitted: December 4, 2018)

• Proportion of patients that enroll in the companion trial recommended by the Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy (COLOMATE) committee [ Time Frame: Up to 5 years ]
  This is defined as the total number of patients that enroll in the recommended companion trial divided by the total number of patients who have an actionable genomic profile. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
• The proportion of patients who have an actionable genomic profile [ Time Frame: Up to 5 years ]
  This is defined as the total number of patients who have an actionable genomic profile divided by the total number of patients that are screened on the COLOMATE protocol. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial
• Official Title: COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy
• Brief Summary: This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.

Detailed Description

PRIMARY OBJECTIVES:

I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.

II. To facilitate clinically annotated genomic analyses.

OUTLINE:

Patients submit blood samples for genetic testing.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood

• Sampling Method: Non-Probability Sample
• Study Population: Patients with adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable

Condition

• Metastatic Colon Adenocarcinoma
• Metastatic Rectal Adenocarcinoma
• Stage III Colon Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8
• Stage IIIA Colon Cancer AJCC v8
• Stage IIIA Rectal Cancer AJCC v8
• Stage IIIB Colon Cancer AJCC v8
• Stage IIIB Rectal Cancer AJCC v8
• Stage IIIC Colon Cancer AJCC v8
• Stage IIIC Rectal Cancer AJCC v8
• Stage IV Colon Cancer AJCC v8
• Stage IV Rectal Cancer AJCC v8
• Stage IVA Colon Cancer AJCC v8
• Stage IVA Rectal Cancer AJCC v8
• Stage IVB Colon Cancer AJCC v8
• Stage IVB Rectal Cancer AJCC v8
• Stage IVC Colon Cancer AJCC v8
• Stage IVC Rectal Cancer AJCC v8
• Unresectable Colon Adenocarcinoma
• Unresectable Rectal Adenocarcinoma

Intervention

Other: Genetic Testing

Undergo genetic testing

Other Names:

• genetic analysis
• Genetic Examination
• Genetic Test

Study Groups/Cohorts

Screening (genetic testing)

Patients submit blood samples for genetic testing.

Intervention: Other: Genetic Testing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 4, 2018): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 12, 2025
• Estimated Primary Completion Date: November 11, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
• Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)

• For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)

  • Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
• At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
• Life expectancy >= 3 months per estimation of investigator
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• Capable of understanding and complying with the protocol requirements and has signed the informed consent document

• Satisfy at least one of the following two conditions:

  • Willing and able to provide blood sample for screening purposes
  • Guardant 360 testing completed =< 60 days prior to registration

Exclusion Criteria:

• Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of < 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
• Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
• History of solid organ transplantation
• Pregnant or planning to become pregnant within the next 12 months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03765736
• Other Study ID Numbers: ACCRU-GI-1611; NCI-2018-02862 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); ACCRU-GI-1611 ( Other Identifier: Academic and Community Cancer Research United ); P30CA015083 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Academic and Community Cancer Research United
• Original Responsible Party: Same as current
• Current Study Sponsor: Academic and Community Cancer Research United
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: John H Strickler; Academic and Community Cancer Research United

• PRS Account: Academic and Community Cancer Research United
• Verification Date: May 2023