RECRUITING

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

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Conditions

Malignant Female Reproductive System NeoplasmMalignant Solid NeoplasmRecurrent Malignant Female Reproductive System NeoplasmRecurrent Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.

Official Title

A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial

Quick Facts

Study Start:2024-05-07
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06126276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
  2. * Patients must have a HER2 amplified solid tumor except breast cancer. Patient's cancer must have HER2 amplification as defined with ≥ 7 copies by next generation sequencing (NGS) testing
  3. * Patients must have recurrent or persistent disease
  4. * No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation
  5. * Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
  6. * Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required
  7. * Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic
  8. * No known leptomeningeal disease
  9. * Patients may have received up to 5 prior lines of systemic therapy
  10. * Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
  11. * Prior therapy with tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib is not allowed
  12. * No prior therapy with CDK4/6 inhibition
  13. * No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration
  14. * Age ≥ 18
  15. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  16. * Not pregnant and not nursing
  17. * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  18. * Platelets ≥ 100,000 cells/mm\^3
  19. * Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)
  20. * Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  21. * Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
  22. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)
  23. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  24. * No active infection requiring parenteral antibiotics
  25. * No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
  26. * No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy
  27. * No lung disease causing dyspnea at rest
  28. * No interstitial lung disease with ongoing signs and symptoms at the time of registration
  29. * No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Haider S Mahdi
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688
United States
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
UPMC Western Maryland
Cumberland, Maryland, 21502
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072
United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Community Hospital of Anaconda
Anaconda, Montana, 59711
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Logan Health Medical Center
Kalispell, Montana, 59901
United States
Community Medical Center
Missoula, Montana, 59804
United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
United States
Jersey City Medical Center
Jersey City, New Jersey, 07302
United States
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
Upper Valley Medical Center
Troy, Ohio, 45373
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
UPMC Altoona
Altoona, Pennsylvania, 16601
United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Haider S Mahdi, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-07
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2024-05-07
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Female Reproductive System Neoplasm
  • Malignant Solid Neoplasm
  • Recurrent Malignant Female Reproductive System Neoplasm
  • Recurrent Malignant Solid Neoplasm