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This website is an information resource intended only for Healthcare Professionals from U.S. who are interested in information on Clinical Research and EMD Serono clinical trials.

By clicking "I am a healthcare professional" you are declaring and confirming that you are a Healthcare Professional inside the U.S. and have read and understood this disclaimer.

PERSPECTIVE

Page last updated: 08/17/2020

 

A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided Metastatic Colorectal Cancer (mCRC) Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification

ClinicalTrials.gov:

NCT04515394

ADVANCED
METASTATIC Advanced diseaseAdvanced disease means that the cancer has spread to a nearby tissue or lymph node or spread to another part of the body.2

PHASE 2 Phase 2 trialA phase 2 trial is a type of clinical trial which tests the clinical activity in a specific type of cancer or disease. Phase 2 trials may also provide information about the safety of the new treatment and how the treatment affects the body.3

COMBINATION
THERAPY Combination therapyA therapy where a patient is treated with more than one type of cancer treatment. The different cancer treatments usually work in different ways to try and improve the effect of the treatment4

ENROLLING SOON

Purpose of this study


 

In this phase 2 trial, the safety and efficacy of tepotinib, an oral once-daily MET inhibitor, is investigated in combination with cetuximab in patients with RAS/BRAF wild-type left-sided metastatic CRC and acquired resistance to prior anti-EGFR monoclonal antibody therapy due to MET amplification

This trial will measure:*

  • Objective response rate
  • Duration of response
  • Progression-free survival

Key eligibility criteria*


  • Locally advanced or metastatic left-sided CRC with documented RAS/BRAF wild-type
  • Acquired resistance to the most recent anti-EGFR monoclonal antibody therapy
  • MET amplification 
  • ECOG Performance Status 0-1

 

 

Key exclusion criteria*


  • Patients with symptomatic CNS metastases who are neurologically unstable, or who have brain metastases as the only measurable lesion
  • Prior cancer therapy other than anti-EGFR containing regimen including associated chemotherapy, within 21 days prior to the first dose of study treatment
  • Discontinuation of most recent cetuximab- or panitumumab-containing therapy due to adverse event

 

*For a full list of all outcome measures, inclusion and exclusion criteria, please visit clinicaltrials.gov, NCT04515394.

Study design

 

 

* Target enrollment.
** Treatment continues until progression of disease, withdrawal of consent, or development of unacceptable toxicities. Initial dose give will be 450 mg/m2.

 DOR: duration of response; DC: disease control; PFS: progression-free survival; OS: overall survival; HRQOL: health-related quality of life

  

 

Speak with a doctor to see if a clinical trial is the right option for you.

If you are interested in learning more about clinical trials (or these clinical trials) please visit clincaltrials.gov

 

 

Tepotinib is being investigated in this clinical trial and under clinical investigation in several countries of the worldThis page describes one of the clinical trials for tepotinib, and it includes information about how the safety and efficacy of tepotinib will be measured and evaluated. Safety and efficacy of tepotinib have to be investigated following the respective local regulations and laws. There is no guarantee that tepotinib will be approved in the sought-after indication by the competent health authority in your country.

You should speak with your doctor, who can help you decide whether a clinical trial might be right for you. Your doctor will be able to answer questions you might have about the risk of participating in a trial, and what other options may be available to you.

LOCATIONS

LOCATION CITY STATE POSTAL CODE COUNTRY STATUS

ClinicalTrials.gov. Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations (VISION). https://clinicaltrials.gov/ct2/show/NCT02864992. Accessed April 3, 2020.

2 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/advanced-cancer. Accessed April 5, 2020.

3 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/799321. Accessed April  5, 2020.

4 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/monotherapy. Accessed April 7, 2020.

5 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/794425. Accessed April 7, 2020.

6 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/non-small-cell-lung-cancer. Accessed April 7, 2020.

Drilon A et al. J Thorac Oncol. 2017;12:15-26.

National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/performance-status. Accessed April 7, 2020.

9 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/egfr. Accessed April 7, 2020.

10 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/alk-gene. Accessed April 7, 2020.

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