Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body (ON-TRK)

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
• Intervention / Treatment: Drug: larotrectinib(Vitrakvi, BAY2757556)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Argentina
  • Multiple Locations, Argentina
    • Active, not recruiting
    • Many Locations
• Australia
  • Multiple Locations, Australia
    • Not yet recruiting
    • Many Locations
• Austria
  • Multiple Locations, Austria
    • Active, not recruiting
    • Many Locations
• Belgium
  • Multiple Locations, Belgium
    • Active, not recruiting
    • Many Locations
• Brazil
  • Multiple Locations, Brazil
    • Withdrawn
    • Many Locations
• Canada
  • Multiple Locations, Canada
    • Completed
    • Many Locations
• China
  • Multiple Locations, China
    • Active, not recruiting
    • Many Locations
• Denmark
  • Multiple Locations, Denmark
    • Withdrawn
    • Many Locations
• Finland
  • Multiple Locations, Finland
    • Active, not recruiting
    • Many Locations
• France
  • Multiple Locations, France
    • Active, not recruiting
    • Many Locations
• Germany
  • Multiple Locations, Germany
    • Active, not recruiting
    • Many Locations
• Greece
  • Multiple Locations, Greece
    • Not yet recruiting
    • Many Locations
• Ireland
  • Multiple Locations, Ireland
    • Withdrawn
    • Many Locations
• Italy
  • Multiple Locations, Italy
    • Active, not recruiting
    • Many Locations
• Japan
  • Multiple Locations, Japan
    • Withdrawn
    • Many Locations
• Luxembourg
  • Multiple Locations, Luxembourg
    • Active, not recruiting
    • Many Locations
• Norway
  • Multiple Locations, Norway
    • Withdrawn
    • Many Locations
• Russia
  • Multiple Locations, Russia
    • Withdrawn
    • Many Locations
• Singapore
  • Multiple Locations, Singapore
    • Withdrawn
    • Many Locations
• South Korea
  • Multiple Locations, South Korea
    • Active, not recruiting
    • Many Locations
• Spain
  • Multiple Locations, Spain
    • Active, not recruiting
    • Many Locations
• Sweden
  • Multiple Locations, Sweden
    • Active, not recruiting
    • Many Locations
• Switzerland
  • Multiple Locations, Switzerland
    • Active, not recruiting
    • Many Locations
• Taiwan
  • Multiple Locations, Taiwan
    • Withdrawn
    • Many Locations
• United Kingdom
  • Multiple Locations, United Kingdom
    • Not yet recruiting
    • Many Locations
• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Withdrawn
      • Banner Desert Medical Center
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • California Research Inst.
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA - Mattel Children's Hospital
    • Los Angeles, California, United States, 90089
      • Withdrawn
      • USC / Norris Comprehensive Cancer Center
    • Newport Beach, California, United States, 82663
      • Recruiting
      • Hoag Memorial Hospital Presbyterian
    • Oakland, California, United States, 94609
      • Withdrawn
      • UCSF Benioff Children's Hospital Oakland
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
    • Santa Monica, California, United States, 90404
      • Terminated
      • Providence Health System - Southern California
    • Torrance, California, United States, 90502
      • Withdrawn
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • Withdrawn
      • SCL Health
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Withdrawn
      • Mayo Clinic
    • Miami, Florida, United States, 33155
      • Recruiting
      • Nicklaus Children's Hospital
    • Miami, Florida, United States, 33146
      • Recruiting
      • University of Miami
    • Orlando, Florida, United States, 32827
      • Withdrawn
      • Nemours Children's Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology Hematology
    • Terre Haute, Indiana, United States, 47802
      • Withdrawn
      • Regional Health Hope Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Cancer Center of Kansas
  • Maine
    • South Portland, Maine, United States, 04106
      • Recruiting
      • Maine Health
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Withdrawn
      • Univ. of Maryland / Greenebaum Comp. Cancer Ctr.
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins / Sidney Kimmel Cancer Center
    • Frederick, Maryland, United States, 21702
      • Terminated
      • Frederick Health-James M Stockman Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts / Neely Cancer Center
    • Boston, Massachusetts, United States, 02215
      • Withdrawn
      • Boston Children's / Dana Farber
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Detroit Clinical Research Center
    • Lansing, Michigan, United States, 48912
      • Recruiting
      • Sparrow Cancer Center
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Recruiting
      • Nevada Cancer Research Foundation
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Withdrawn
      • Atlantic Hem Onc / Morristown Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Withdrawn
      • Rutgers Cancer Institute of New Jersey
  • New York
    • Buffalo, New York, United States, 14210
      • Terminated
      • Great Lakes Cancer Center
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Children's Cancer Center
    • Staten Island, New York, United States, 10305
      • Withdrawn
      • Staten Island Univ. Hospital (Northwell Health)
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Withdrawn
      • Levine Cancer Center
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University / Vidant Health
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Withdrawn
      • Ohio State Comp. Cancer Ctr. / James Cancer Hospital
    • Youngstown, Ohio, United States, 44501
      • Recruiting
      • Mercy Health Youngstown
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • Withdrawn
      • University of Pennsylvania (Penn Med)
    • Pittsburgh, Pennsylvania, United States, 15212
      • Terminated
      • Allegheny Health Network
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical Univ. of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Withdrawn
      • St. Jude Children's Research Hospital
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center / Children's Health
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
  • Utah
    • Murray, Utah, United States, 84107
      • Withdrawn
      • Intermountain Healthcare - Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Univ. of Utah / Huntsman Cancer Center
    • St. George, Utah, United States, 84790
      • Withdrawn
      • Intermountain Healthcare - Dixie Regional Medical Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Recruiting
      • Gundersen Health System
    • Madison, Wisconsin, United States, 53717
      • Terminated
      • SSM Health Cancer Center - Dean Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment

Description

Inclusion Criteria:

• Adult and pediatric (from birth to 18-year-old) patients
• Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
• Life expectancy of at least 3 months based on clinical judgement
• Decision to treat with larotrectinib made by the treating physician prior to study enrollment
• Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
• Signed informed consent form
• For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

• Any contraindications as listed in the local approved product information
• Pregnancy
• Participation in an investigational program with interventions outside of routine clinical practice
• Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
• Patients with NTRK gene amplification or NTRK point mutation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GI; adult patients with gastrointestinal (GI) cancer	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
H&N; adult patients with head and neck (H&N) cancer	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
STS; adult patients with soft tissue sarcoma (STS)	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
CNS; adult patients with primary central nervous system (CNS) cancer	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Lung; adult patients with lung cancer	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Melanoma; adult patients with melanoma	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Pediatric; all pediatric patients regardless of tumor type will be enrolled under this cohort	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
other; patients with other tumor types	Drug: larotrectinib(Vitrakvi, BAY2757556); In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)	Up to 30 days after last dose
Severity of TEAEs	Up to 30 days after last dose
Seriousness of TEAEs	Up to 30 days after last dose
Causality of TEAEs	Up to 30 days after last dose
Action taken related to larotrectinib treatment	Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE	Up to 30 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)		Up to 8 years
Disease control rate (DCR)		Up to 8 years
Duration of response (DOR)		Up to 8 years
Time to response (TTR)		Up to 8 years
Progression-free survival (PFS)		Up to 8 years
Overall survival (OS)		Up to 8 years
Total dose		Up to 8 years
Starting and ending dose		Up to 8 years
Dose modification during treatment		Up to 8 years
Duration of treatment (DOT)		Up to 8 years
ORR by patient subgroup(s)		Up to 8 years
DCR by patient subgroup(s)		Up to 8 years
DOR by patient subgroup(s)		Up to 8 years
TTR by patient subgroup(s)		Up to 8 years
PFS by patient subgroup(s)		Up to 8 years
OS by patient subgroup(s)		Up to 8 years
Number of patients with abnormal developmental milestones	Pediatric cohort only	Up to 8 years
Number of patients with abnormal Tanner stage	Pediatric cohort only	Up to 8 years
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)	for all patients	Up to 8 years

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, Lopez-Rios F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: larotrectinib
• Other Study ID Numbers: 20324

Plan for Individual participant data (IPD)

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

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No