RECRUITING

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)

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 tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.

Official Title

A Randomized Phase II Study of AMG 510 (Sotorasib) With or Without Panitumumab in Advanced Solid Tumors: A ComboMATCH Treatment Trial

Quick Facts

Study Start:2024-08-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05638295

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-E5 based on the presence of an actionable mutation as defined in EAY191
  2. * Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration/randomization to the EAY191-E5 study
  3. * Patient must be \>= 18 years of age
  4. * Patient must have a KRAS G12C alteration as determined by the ComboMATCH screening assessment
  5. * Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191-E5)
  6. * NOTE: The current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
  7. * NOTE: Novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol
  8. * Patient must have cytologically/histologically confirmed advanced/metastatic solid tumor
  9. * Patient must have progressed on at least one line of standard of care therapy in the advanced/metastatic setting
  10. * NOTE: Patients who have progressed on a prior human epidermal growth factor receptor (EGFR) inhibitor will meet this criterion
  11. * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 (or Karnofsky performance status \>= 60%)
  12. * Patient must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) documented by imaging obtained within 28 days prior to registration/randomization
  13. * Patient must not have any serious active infection within 4 weeks prior to EAY191-E5 registration/randomization (e.g., requiring hospitalization and/or intravenous \[IV\] antibiotics) or currently receiving oral or IV antibiotics for the treatment of infection. Patients receiving prophylactic antibiotics are eligible
  14. * Patient must have the ability to retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
  15. * Patient must not have any history of or current evidence of non-infectious interstitial lung disease (ILD)/pneumonitis
  16. * Patient must not have a history of allergic reactions attributed to either of the study agents or to agents of similar chemical or biologic composition
  17. * Patient must have completed full treatment cycle 21 days prior to EAY191-E5 registration/randomization if they have received prior chemotherapy, biological cancer therapy, radiation therapy or an investigational agent/device. Patients must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from any adverse events due to prior cancer therapy (with the exception of alopecia)
  18. * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration/randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  19. * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 6 months after the last dose of protocol treatment. Patients must not breastfeed while receiving protocol treatment and for one week (7 days) after the last dose of AMG 510 (sotorasib) and 2 months after the last dose of panitumumab
  20. * Patients must not have neuropathy ≥ grade 2 within 14 days prior to registration/randomization
  21. * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  22. * Human immunodeficiency virus (HIV)-infected patients no effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  23. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  24. * Patients with known history or current symptoms of cardiac history, 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 trail, patients should be class 2B or better
  25. * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 28 days prior to protocol registration/randomization)
  26. * Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (\[SGPT\]) \< 3 x institutional upper limit of normal (obtained ≤ 28 days prior to protocol registration/randomization)
  27. * Creatinine =\< 1.5 x institutional ULN OR creatinine clearance \> 50 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 mg/dL as per Cockcroft-Gault (obtained ≤ 28 days prior to protocol registration/randomization)
  28. * COHORT I: Patient must not have colorectal cancer or non-small cell lung cancer
  29. * COHORT I: Patient must not have been previously treated with a KRAS G12C inhibitor
  30. * COHORT II: Patient must have progressed after treatment at the recommended phase II dose (RP2D) of any KRAS G12C inhibitor
  31. * NOTE: Patients on cohort 1 who experience progression on Regimen 2 (AMG 510 \[sotorasib\] alone) may be eligible to enroll on cohort 2 and receive combination treatment with panitumumab and AMG 510 (sotorasib). Patients must meet performance status requirements and laboratory values as above and must be begin treatment within 7 days of enrollment. Migration to cohort 2 must take place within 6 months of progression, with no intervening anti-cancer therapy given.
  32. * NOTE: Cohort migration following disease progression is dependent on a slot being available. MATCHBox makes the new treatment assignment following initiation of a step 2 registration for this treatment trial
  33. * COHORT II: Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor
  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

Kristen R Spencer
PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
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
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
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
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
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
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Advocate Sherman Hospital
Elgin, Illinois, 60123
United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
United States
Condell Memorial Hospital
Libertyville, Illinois, 60048
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
United States
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
United States
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
United States
Memorial Hospital East
Shiloh, Illinois, 62269
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
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
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 Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Chelsea Hospital
Chelsea, Michigan, 48118
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
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 Children's
Royal Oak, Michigan, 48073
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661
United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri, 63136
United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
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
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Grant Medical Center
Columbus, Ohio, 43215
United States
Doctors Hospital
Columbus, Ohio, 43228
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
United States
Grady Memorial Hospital
Delaware, Ohio, 43015
United States
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
United States
Dublin Methodist Hospital
Dublin, Ohio, 43016
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302
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
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122
United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Kristen R Spencer, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

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 Date2024-08-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm