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Chemotherapy
Tucatinib + Trastuzumab + Chemotherapy for Colorectal Cancer (MOUNTAINEER-03 Trial)
Phase 3
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 years
Awards & highlights
MOUNTAINEER-03 Trial Summary
This trial is testing to see if tucatinib in combination with other drugs is more effective than standard of care drugs at treating participants with HER2 positive colorectal cancer.
Who is the study for?
This trial is for adults with HER2 positive, RAS WT metastatic or unresectable colorectal cancer who haven't had systemic anticancer therapy in the metastatic setting. They should have measurable disease and be in good physical condition (ECOG 0-1). Prior adjuvant chemotherapy is allowed if completed over 6 months ago. Excluded are those with recent radiation, ongoing severe neuropathy, GI perforation within a year, or past anti-HER2 treatment.Check my eligibility
What is being tested?
The study compares tucatinib combined with trastuzumab and mFOLFOX6 against standard treatments for advanced colorectal cancer. Participants will randomly receive either this new combination or one of the standard options: mFOLFOX6 alone, with bevacizumab, or cetuximab. The goal is to see if tucatinib improves outcomes.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to drugs like tucatinib and trastuzumab; digestive issues from chemotherapy agents; nerve damage risks from oxaliplatin; and general symptoms such as fatigue and increased risk of infections.
MOUNTAINEER-03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My colon or rectum cancer is advanced and cannot be removed by surgery.
Select...
My cancer is HER2 positive based on a specialized lab test.
Select...
I have provided a recent biopsy of my tumor if no older samples were available.
Select...
My cancer can be measured on scans and has grown after any previous radiation.
MOUNTAINEER-03 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
Secondary outcome measures
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
DOR per RECIST v1.1 by investigator assessment
+9 moreSide effects data
From 2022 Phase 2 trial • 612 Patients • NCT0261479482%
Diarrhoea
66%
Palmar-plantar erythrodysaesthesia syndrome
60%
Nausea
48%
Fatigue
38%
Vomiting
27%
Decreased appetite
26%
Stomatitis
24%
Headache
23%
Aspartate aminotransferase increased
22%
Anaemia
22%
Alanine aminotransferase increased
20%
Blood bilirubin increased
20%
Arthralgia
18%
Hypokalaemia
17%
Constipation
17%
Cough
16%
Abdominal pain
16%
Blood creatinine increased
15%
Weight decreased
14%
Back pain
13%
Epistaxis
13%
Pain in extremity
13%
Dizziness
13%
Peripheral sensory neuropathy
13%
Dyspnoea
11%
Dry skin
11%
Dyspepsia
11%
Upper respiratory tract infection
11%
Urinary tract infection
11%
Muscle spasms
11%
Oedema peripheral
10%
Pruritus
10%
Insomnia
9%
Hypomagnesaemia
9%
Neutropenia
9%
Abdominal pain upper
8%
Dehydration
8%
Asthenia
8%
Myalgia
8%
Dysgeusia
8%
Oropharyngeal pain
8%
Skin hyperpigmentation
7%
Rash maculo-papular
7%
Hypophosphataemia
7%
Blood alkaline phosphatase increased
7%
Thrombocytopenia
7%
Abdominal distension
7%
Hyperbilirubinaemia
7%
Fall
7%
Rhinorrhoea
6%
Paraesthesia
6%
Dry eye
6%
Hyperglycaemia
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Pyrexia
6%
Paronychia
6%
Alopecia
5%
White blood cell count decreased
5%
Dry mouth
5%
Neutrophil count decreased
5%
Platelet count decreased
5%
Muscular weakness
5%
Hypertension
5%
Nasopharyngitis
3%
Seizure
2%
Pneumonia
2%
Influenza
1%
Cholecystitis
1%
Sepsis
1%
Ejection fraction decreased
1%
Syncope
1%
Pleural effusion
1%
Pulmonary embolism
1%
Cardiac failure
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tuc+Cap+Tra
Pbo+Cap+Tra
MOUNTAINEER-03 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tucatinib ArmExperimental Treatment6 Interventions
Tucatinib + trastuzumab + mFOLFOX6
Group II: Standard of Care ArmActive Control6 Interventions
mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fluorouracil
1994
Completed Phase 3
~8440
leucovorin
2005
Completed Phase 3
~1200
trastuzumab
2002
Completed Phase 3
~1790
oxaliplatin
2002
Completed Phase 3
~6370
tucatinib
2018
Completed Phase 2
~800
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
68,757 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,294 Total Patients Enrolled
James Ward, MDStudy DirectorSeagen Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.My colon or rectum cancer is advanced and cannot be removed by surgery.My cancer is RAS wild-type.My cancer is HER2 positive based on a specialized lab test.I've had treatment for colorectal cancer, but no more than 2 doses of mFOLFOX6 if it was in advanced stages.My cancer is RAS wild-type.I have at least one tumor that can be measured and hasn't been treated with radiation, or it has grown since being radiated.I have not had a GI perforation in the last year.I have been treated with anti-HER2 therapy before.I have severe nerve pain or damage.My brain scans show no new growths or only treated, symptom-free growths.I have provided a recent biopsy of my tumor if no older samples were available.I have not had radiation therapy in the last 14 days, or 7 days if it was stereotactic radiosurgery.I can provide recent tumor samples for testing before starting treatment.My cancer can be measured on scans and has grown after any previous radiation.My cancer is HER2 positive based on a specialized lab test.My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Tucatinib Arm
- Group 2: Standard of Care Arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How large is the sample size for this clinical trial?
"Yes, as specified on clinicaltrials.gov, this particular trial is still recruiting patients. 400 participants are needed in total, and 28 different hospitals or clinics across the country are enrolling individuals for the study."
Answered by AI
Are patients still being sought for this research program?
"The information available on clinicaltrials.gov affirms that this study is currently looking for enrollees. The trial was first posted on November 30th, 2020 and was last updated a month ago, on October 31st. They are expecting to have 400 people participate at 28 different locations."
Answered by AI
What is the FDA's stance on tucatinib?
"Tucatinib's safety was given a 3 because it is in Phase 3 clinical trials. This means that there is data supporting both its efficacy and safety from multiple rounds of testing."
Answered by AI
At how many different hospitals is this clinical trial being conducted?
"To enroll in this trial, patients must visit one of the 28 clinics conducting the study. The facilities are situated in Saint Louis Park, Los Angeles, Vancouver and other cities. To cut down on travel time and costs, please choose the closest location to you."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Pacific Cancer Medical Center
Providence Portland Medical Center
HealthPartners Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
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