TCF-001 TRACK (Target Rare Cancer Knowledge) Study (TRACK)

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma; Cancer of Unknown Primary Site; Rare Cancers
• Intervention / Treatment: Diagnostic test: FoundationOne CDx and FoundationOne Liquid CDx

Detailed Description

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results. The study leverages a remote consent and participation approach to open enrollment to all patients with rare tumors within the United States. Traditional, site-based patient consenting and participation is also available for enrollment to the study.

Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating cell-free DNA may be additionally collected for repeat CGP at various timepoints during the study.

The CGP findings will be provided by FMI directly to the treating physician and study sponsor TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions. The resultant treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Oster; Phone Number: 617-299-0389; Email: Mary@targetcancerfoundation.org

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • TargetCancer Foundation
      • Contact: Mary Oster; Phone Number: 617-299-0389; Email: Mary@targetcancerfoundation.org
      • Principal Investigator: Shumei Kato, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study related blood draws and assessments for the duration of the study.
• Individuals who are 18 years old or older at the time of consent.
• Patients with a rare (fewer than 6 cases per 100,000 per year) solid tumor or lymphoma with evaluable disease at baseline. The complete list of included cancers are included in the study protocol; diseases not listed in the study protocol may be enrolled with the approval of the Principal Investigator.
• May or may not have had qualifying (by Foundation Medicine) comprehensive genomic profiling before the present study. For those who have had qualifying comprehensive genomic profiling performed prior to the present study, the archival specimen tested must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study.
• Willingness to provide existing archived and/or newly collected tissue resulting from standard of care procedures and blood samples for genomic profiling. If the submitted sample is determined to be insufficient for testing, the patient will be considered to be a screen failure.
• For archival tissue to be used for comprehensive genomic profiling for the present study, that specimen must have been harvested within 18 months of the baseline visit (i.e. date of consent) of the present study.
• Willingness to provide clinical and medical information to the study team as required.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Ability to read, write and communicate in English.
• Ability to review and sign a web-based informed consent form, or review and sign an informed consent form in treating physician office.
• Resides within the United States.

EXCLUSION CRITERIA

• Participants who are unable to provide informed consent.
• Participants who are 17 years of age or younger.
• Participants who are unable to comply with the study procedures.
• Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
• Concurrent active malignancy requiring treatment within 1 year of enrollment, at the discretion of treating physician.
• Pregnancy or breastfeeding.
• Any unlisted criteria at the discretion of the treating physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cholangiocarcinoma; Eligible patients that present with Cholangiocarcinoma.	Diagnostic test: FoundationOne CDx and FoundationOne Liquid CDx; Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.; Other Names: FoundationOne CDx; FoundationOne Liquid CDx
Active Comparator: Cancer of Unknown Primary (CUP); Eligible patients with cancer of unknown primary site (CUP).	Diagnostic test: FoundationOne CDx and FoundationOne Liquid CDx; Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.; Other Names: FoundationOne CDx; FoundationOne Liquid CDx
Active Comparator: Other remaining rare cancers (solid tumors & lymphomas); Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).	Diagnostic test: FoundationOne CDx and FoundationOne Liquid CDx; Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.; Other Names: FoundationOne CDx; FoundationOne Liquid CDx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.	The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.	2 years
Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.	The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Tumor Biomarker Profiling to Treatment Outcome.	Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).	2 years

Collaborators and Investigators

• Sponsor: TargetCancer Foundation
• Collaborators: Foundation Medicine
• Investigators: Principal Investigator: Razelle Kurzrock, M.D., Medical College of Wisconsin; Principal Investigator: Vivek Subbiah, M.D., The University of Texas MD Anderson Cancer Center (MDACC); Principal Investigator: Shumei Kato, M.D., University of California, San Diego

Publications and helpful links

Helpful Links

• Study information

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: genomics; solid tumors; targeted therapy; virtual; cell-free DNA; next generation sequencing; patient reported outcomes; precision medicine; molecular tumor board; remote participation; understudied diseases; comprehensive genomic profiling; liquid biopsies; tumor biopsies; biomarker testing
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Neoplasm Metastasis; Cholangiocarcinoma; Neoplasms, Unknown Primary
• Other Study ID Numbers: TCF-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No