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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05253651




Registration number
NCT05253651
Ethics application status
Date submitted
14/02/2022
Date registered
24/02/2022
Date last updated
13/11/2024

Titles & IDs
Public title
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
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
Secondary ID [1] 0 0
2021-002672-40
Secondary ID [2] 0 0
SGNTUC-029
Universal Trial Number (UTN)
Trial acronym
MOUNTAINEER-03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tucatinib
Treatment: Drugs - trastuzumab
Treatment: Drugs - bevacizumab
Treatment: Drugs - cetuximab
Treatment: Drugs - oxaliplatin
Treatment: Drugs - leucovorin
Treatment: Drugs - levoleucovorin
Treatment: Drugs - fluorouracil

Experimental: Tucatinib Arm - Tucatinib + trastuzumab + mFOLFOX6

Active comparator: Standard of Care Arm - mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab


Treatment: Drugs: tucatinib
300mg given by mouth (orally) twice daily

Treatment: Drugs: trastuzumab
8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.

Treatment: Drugs: bevacizumab
5mg/kg given by IV every 2 weeks

Treatment: Drugs: cetuximab
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly

Treatment: Drugs: oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

Treatment: Drugs: leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

Treatment: Drugs: levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.

Treatment: Drugs: fluorouracil
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
PFS per RECIST v1.1 by investigator assessment
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
cORR per RECIST v1.1 by investigator assessment
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Duration of response (DOR) per RECIST v1.1 by BICR
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
DOR per RECIST v1.1 by investigator assessment
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Time to second progression or death (PFS2)
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Incidence of adverse events (AEs)
Timepoint [8] 0 0
Through 30 days after the last study treatment; approximately 1 year
Secondary outcome [9] 0 0
Incidence of dose alterations
Timepoint [9] 0 0
Through 30 days after the last study treatment; approximately 1 year
Secondary outcome [10] 0 0
Trough concentration (Ctrough)
Timepoint [10] 0 0
Approximately 4 months
Secondary outcome [11] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Timepoint [11] 0 0
Through 30-37 days after the last study treatment; approximately 1 year
Secondary outcome [12] 0 0
Time to meaningful change in EORTC QLQ30 score
Timepoint [12] 0 0
Through 30-37 days after the last study treatment; approximately 1 year

Eligibility
Key inclusion criteria
* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory

* If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
* HER2+ disease as determined by a tissue based assay performed at a central laboratory.
* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
* Radiographically measurable disease per RECIST v1.1 with:

* At least one site of disease that is measurable and that has not been previously irradiated, or
* If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:

* No evidence of brain metastases
* Previously treated brain metastases which are asymptomatic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.

* Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
* Previous treatment with anti-HER2 therapy
* Ongoing Grade 3 or higher neuropathy
* Active or untreated gastrointestinal (GI) perforation at the time of screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Othe
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Townsville Cancer Center - Townsville
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
4814 - Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Other
Country [19] 0 0
Austria
State/province [19] 0 0
Other
Country [20] 0 0
Belgium
State/province [20] 0 0
Other
Country [21] 0 0
Belgium
State/province [21] 0 0
Haine-Saint-Paul
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Brazil
State/province [23] 0 0
Other
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Canada
State/province [26] 0 0
Saskatchewan
Country [27] 0 0
Chile
State/province [27] 0 0
Other
Country [28] 0 0
China
State/province [28] 0 0
Other
Country [29] 0 0
France
State/province [29] 0 0
Other
Country [30] 0 0
France
State/province [30] 0 0
Brest
Country [31] 0 0
Germany
State/province [31] 0 0
Other
Country [32] 0 0
Greece
State/province [32] 0 0
Other
Country [33] 0 0
Hungary
State/province [33] 0 0
Other
Country [34] 0 0
Ireland
State/province [34] 0 0
Other
Country [35] 0 0
Ireland
State/province [35] 0 0
Dublin
Country [36] 0 0
Italy
State/province [36] 0 0
Other
Country [37] 0 0
Italy
State/province [37] 0 0
Avellino
Country [38] 0 0
Italy
State/province [38] 0 0
Firenze
Country [39] 0 0
Japan
State/province [39] 0 0
Other
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Other
Country [41] 0 0
Netherlands
State/province [41] 0 0
Other
Country [42] 0 0
Norway
State/province [42] 0 0
Other
Country [43] 0 0
Poland
State/province [43] 0 0
Other
Country [44] 0 0
Portugal
State/province [44] 0 0
Other
Country [45] 0 0
Slovakia
State/province [45] 0 0
Other
Country [46] 0 0
Spain
State/province [46] 0 0
Other
Country [47] 0 0
Switzerland
State/province [47] 0 0
Other
Country [48] 0 0
Taiwan
State/province [48] 0 0
Other
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Other

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
clinicaltrials@seagen.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05253651