NCT05253651|RecruitingPhase 3DMCFDA Drug

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

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

Seagen, a wholly owned subsidiary of Pfizer ClinicalTrials.gov

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3 other identifiers

SGNTUC-029C42510082024-514180-25-00

Study Type

interventional

Target

400

Locations

24 countries

Sites

377

Timeline

RegisteredFeb 2022

StartedOct 2022

CompletionJul 2029

Brief Summary

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

mFOLFOX6 alone,
mFOLFOX6 with bevacizumab, or
mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

400

participants targeted

Target at P50-P75 for phase_3

Timeline

39mo left

Started Oct 2022

Longer than P75 for phase_3

Geographic Reach

24 countries

377 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Progress52%

Oct 2022Jul 2029

First Submitted

Initial submission to the registry

February 14, 2022

Completed

10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed

8 months until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2026

Completed

3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2029

Expected

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

February 14, 2022

Last Update Submit

March 13, 2026

Conditions

Colorectal Neoplasms

Keywords

Colorectal CancerCRCSeattle Genetics

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause
Up to approximately 3 years

Secondary Outcomes (12)

Overall survival (OS)
Up to approximately 6 years
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
Up to approximately 3 years
PFS per RECIST v1.1 by investigator assessment
Up to approximately 3 years
cORR per RECIST v1.1 by investigator assessment
Up to approximately 3 years
Duration of response (DOR) per RECIST v1.1 by BICR
Up to approximately 3 years
+7 more secondary outcomes

Study Arms (2)

Tucatinib Arm

EXPERIMENTAL

Tucatinib + trastuzumab + mFOLFOX6

Drug: tucatinibDrug: trastuzumabDrug: oxaliplatinDrug: leucovorinDrug: levoleucovorinDrug: fluorouracil

Standard of Care Arm

ACTIVE COMPARATOR

Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab

Drug: bevacizumabDrug: cetuximabDrug: oxaliplatinDrug: leucovorinDrug: levoleucovorinDrug: fluorouracil

Interventions

trastuzumabDRUG

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.

Also known as: Herceptin

Tucatinib Arm

bevacizumabDRUG

5mg/kg given by IV every 2 weeks

Also known as: Avastin

Standard of Care Arm

cetuximabDRUG

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

Also known as: Erbitux

Standard of Care Arm

oxaliplatinDRUG

85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

Standard of Care ArmTucatinib Arm

leucovorinDRUG

400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

Standard of Care ArmTucatinib Arm

fluorouracilDRUG

400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.

Standard of Care ArmTucatinib Arm

tucatinibDRUG

300mg given by mouth (orally) twice daily

Also known as: TUKYSA, ONT-380, ARRY-380, PF-07265792

Tucatinib Arm

levoleucovorinDRUG

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

Standard of Care ArmTucatinib Arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
No evidence of brain metastases
Previously treated brain metastases which are asymptomatic

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Seagen, a wholly owned subsidiary of Pfizerlead

Study Sites (383)

Palo Verde Hematology Oncology

Glendale, Arizona, 85304, United States

RECRUITING

Mayo Clinic Building - Phoenix

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic

Scottsdale, Arizona, 85259, United States

RECRUITING

Los Angeles Cancer Network - Anaheim

Anaheim, California, 92801, United States

RECRUITING

Kaiser Permanente Anaheim Kraemer Medical Offices

Anaheim, California, 92806, United States

ACTIVE NOT RECRUITING

Kaiser Permanente Baldwin Park Medical Center

Baldwin Park, California, 91706, United States

ACTIVE NOT RECRUITING

Kaiser Permanente Bellflower Medical Offices

Bellflower, California, 90706, United States

ACTIVE NOT RECRUITING

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

ACTIVE NOT RECRUITING

Los Angeles Cancer Network - Fountain Vally

Fountain Valley, California, 92708, United States

RECRUITING

Los Angeles Hematology Oncology Medical Group

Glendale, California, 91204, United States

RECRUITING

Los Angeles Hematology Oncology Medical Group

Glendale, California, 91206, United States

RECRUITING

Kaiser Permanente South Bay Medical center

Harbor City, California, 90710, United States

ACTIVE NOT RECRUITING

Kaiser Permanente Alton/Sand Canyon Medical Offices

Irvine, California, 92618, United States

ACTIVE NOT RECRUITING

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

RECRUITING

USC Norris Koreatown - Medical Oncology

Los Angeles, California, 90020, United States

TERMINATED

Kaiser Permanente Los Angeles Medical Offices

Los Angeles, California, 90027, United States

ACTIVE NOT RECRUITING

Keck Hospital of USC

Los Angeles, California, 90033, United States

TERMINATED

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

TERMINATED

University of Southern California

Los Angeles, California, 90033, United States

TERMINATED

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

TERMINATED

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, 90034, United States

ACTIVE NOT RECRUITING

USC Norris Oncology/Hematology - Newport Beach

Newport Beach, California, 92663, United States

TERMINATED

Kaiser Permanente Ontario Medical Center

Ontario, California, 91761, United States

ACTIVE NOT RECRUITING

Kaiser Permanente Panorama City Medical Center

Panorama City, California, 91402, United States

ACTIVE NOT RECRUITING

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

TERMINATED

Los Angeles Hematology Oncology Medical Group

Pasadena, California, 91105, United States

RECRUITING

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

ACTIVE NOT RECRUITING

Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)

San Diego, California, 92108, United States

ACTIVE NOT RECRUITING

Kaiser Permanente Zion Medical Center

San Diego, California, 92120, United States

ACTIVE NOT RECRUITING

Kaiser Permanente San Marcos Medical Offices

San Marcos, California, 92078, United States

ACTIVE NOT RECRUITING

Los Angeles Hematology Oncology Medical Group

Van Nuys, California, 91405, United States

RECRUITING

Kaiser Permanente Woodland Hills Medical Center

Woodland Hills, California, 91367, United States

ACTIVE NOT RECRUITING