Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

MOUNTAINEER-03 : An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This phase III study is seeking to understand whether targeted therapy (tucatinib + trastuzumab) plus combination chemotherapy (mFOLFOX6) works better than standard of care treatment regimens (such as mFOLFOX6 alone, or given with either cetuximab or bevacizumab), in people with HER2 positive colorectal cancer.
 

This trial is treating patients with HER2+ bowel cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Commercial Sponsor

Seagen Inc.

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive tucatinib + trastuzumab + mFOLFOX6. Tucatinib will be given orally twice daily at a dose of 300mg. Trastuzumab will be given intravenously (IV) first at a 8mg/kg loading dose on Cycle 1 day 1, followed by 6mg/kg every 3 weeks after that. mFOLFOX6 consists of oxaliplatin, fluorouracil + either leucovorin or levoleucovorin. Oxaliplatin will be given via IV every 2 weeks at a dose of 85mg/m2. Leucovorin will be given via IV every 2 weeks at a dose of 400mg/m2. Levoleucovorin will be given via IV every 2 weeks at a dose of 200mg, and may be given in place of leucovorin. Finally, fluorouracil will be given by IV bolus at a dose of 400mg/m2, then 2400mg/m2 given by continuous IV infusion every 2 weeks. In the Active Comparator Arm, participants will receive one of three standard of care treatment regiments: mFOLFOX6 alone, mFOLFOX6 + bevacizumab, or mFOLFOX6 + cetuximab. mFOLFOX6 will be given as described in the Experimental Arm. Where bevacizumab is given, it will be administered via IV every 2 weeks at a dose of 5mg/kg. Where cetuximab is given, it will be administered via IV first at a 400mg/m2 loading dose on Cycle 1 day 1, followed by 250mg/m2 by IV weekly.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9231 3167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next