Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2025-12-31

Brief Summary

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This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer.

The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

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Detailed Description

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Conditions

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Colorectal Carcinoma Gastric Adenocarcinoma GEJ Adenocarcinoma Esophageal Adenocarcinoma Cholangiocarcinoma Gallbladder Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1A

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

leucovorin

Intervention Type DRUG

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

fluorouracil

Intervention Type DRUG

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

Cohort 1B

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

leucovorin

Intervention Type DRUG

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

fluorouracil

Intervention Type DRUG

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

Cohort 1C

Tucatinib + trastuzumab + CAPOX given in 21-day cycles

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

capecitabine

Intervention Type DRUG

1000 mg/m\^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.

Cohort 1D

Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

leucovorin

Intervention Type DRUG

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

fluorouracil

Intervention Type DRUG

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

Cohort 1E

Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

leucovorin

Intervention Type DRUG

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

fluorouracil

Intervention Type DRUG

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

pembrolizumab

Intervention Type DRUG

400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Cohort 1F

Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

capecitabine

Intervention Type DRUG

1000 mg/m\^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.

pembrolizumab

Intervention Type DRUG

400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Cohort 1G

Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

pembrolizumab

Intervention Type DRUG

400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Cohort 2A

Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

leucovorin

Intervention Type DRUG

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

fluorouracil

Intervention Type DRUG

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

capecitabine

Intervention Type DRUG

1000 mg/m\^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.

pembrolizumab

Intervention Type DRUG

400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Cohort 2B

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

trastuzumab

Intervention Type DRUG

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

oxaliplatin

Intervention Type DRUG

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

leucovorin

Intervention Type DRUG

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

fluorouracil

Intervention Type DRUG

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

Interventions

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tucatinib

For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.

Intervention Type DRUG

trastuzumab

Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.

Intervention Type DRUG

oxaliplatin

85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.

Intervention Type DRUG

leucovorin

200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.

Intervention Type DRUG

fluorouracil

400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

Intervention Type DRUG

capecitabine

1000 mg/m\^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.

Intervention Type DRUG

pembrolizumab

400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Intervention Type DRUG

Other Intervention Names

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TUKYSA KEYTRUDA

Eligibility Criteria

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Inclusion Criteria

* Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:

* Cohorts 1A, 1B, 1C, and 1D

* CRC
* Gastric adenocarcinoma
* GEJ adenocarcinoma
* Esophageal adenocarcinoma
* Cholangiocarcinoma
* Gallbladder carcinoma
* Cohorts 1E, 1F, 1G, and 2A

* Gastric adenocarcinoma
* GEJ adenocarcinoma
* Esophageal adenocarcinoma
* Cohort 2B

* CRC
* Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.
* HER2+ disease, as determined by historic or local laboratory testing
* Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator
* Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator
* Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Exclusion Criteria

* History of known hypersensitivity to planned study treatment
* Known to be positive for Hepatitis B or C
* For Cohorts 2A and 2B: prior anti-HER2 therapies
* For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

University of Colorado Denver CTO(CTRC)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, United States

Site Status

PCM Trials

Denver, Colorado, United States

Site Status

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status

Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Site Status

Siteman Cancer Center - North County

Florissant, Missouri, United States

Site Status

Siteman Cancer Center

St Louis, Missouri, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center - South County

St Louis, Missouri, United States

Site Status

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Site Status

Duke University Medical Center, Duke Cancer Center

Durham, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

Site Status

Osaka International Cancer Institute

Osaka, Osaka, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Cancer Institute Hospital of Japanese Foundation for Cancer Research.

Koto-ku, Tokyo, Japan

Site Status

Countries

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United States Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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C4251005

Identifier Type: OTHER

Identifier Source: secondary_id

SGNTUC-024

Identifier Type: -

Identifier Source: org_study_id

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