Various Cancer Types
EAY191-E5
Testing the use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
STATUS: Active
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.
- 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
- Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration/randomization to the EAY191-E5 study
- Patient must be >= 18 years of age
- Patient must have a KRAS G12C alteration as determined by the ComboMATCH screening assessment
- 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) * 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) * NOTE: Novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol
- Patient must have cytologically/histologically confirmed advanced/metastatic solid tumor
- Patient must have progressed on at least one line of standard of care therapy in the advanced/metastatic setting * NOTE: Patients who have progressed on a prior human epidermal growth factor receptor (EGFR) inhibitor will meet this criterion
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 (or Karnofsky performance status >= 60%)
- 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
- 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
- Patient must have the ability to retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
- Patient must not have any history of or current evidence of non-infectious interstitial lung disease (ILD)/pneumonitis
- 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
- 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)
- 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)
- 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
- Patients must not have neuropathy ≥ grade 2 within 14 days prior to registration/randomization
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Human immunodeficiency virus (HIV)-infected patients no effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- 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
- 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
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 28 days prior to protocol registration/randomization)
- 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)
- 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)
- COHORT I: Patient must not have colorectal cancer or non-small cell lung cancer
- COHORT I: Patient must not have been previously treated with a KRAS G12C inhibitor
- COHORT II: Patient must have progressed after treatment at the recommended phase II dose (RP2D) of any KRAS G12C inhibitor * 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. * 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
- COHORT II: Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor
United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu
CA
Los Angeles
Cedars Sinai Medical Center
Contact: Site Public Contact
The Angeles Clinic and Research Institute - West Los Angeles Office
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
FL
Jacksonville
Mayo Clinic in Florida
Contact: Site Public Contact
IA
Ankeny
Mission Cancer and Blood - Ankeny
Contact: Site Public Contact
Des Moines
Mission Cancer and Blood - Des Moines
Contact: Site Public Contact
ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org
Meridian
Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org
Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
IL
Barrington
Advocate Good Shepherd Hospital
Contact: Site Public Contact
Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact
Crystal Lake
AMG Crystal Lake - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocate.com
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Downers Grove
Advocate Good Samaritan Hospital
Contact: Site Public Contact
Email: Barbara.barhamand@advocatehealth.com
Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com
Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Elgin
Advocate Sherman Hospital
Contact: Site Public Contact
Hazel Crest
Advocate South Suburban Hospital
Contact: Site Public Contact
Libertyville
AMG Libertyville - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com
Condell Memorial Hospital
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com
Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com
Maywood
Loyola University Medical Center
Contact: Site Public Contact
Oak Lawn
Advocate Christ Medical Center
Contact: Site Public Contact
Advocate Outpatient Center - Oak Lawn
Contact: Site Public Contact
Email: ncorp@aah.org
Palos Heights
Advocate High Tech Medical Park
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Email: ncorp@aah.org
Park Ridge
Advocate Lutheran General Hospital
Contact: Site Public Contact
Shiloh
Memorial Hospital East
Contact: Site Public Contact
Email: dschwab@wustl.edu
Springfield
Southern Illinois University School of Medicine
Contact: Site Public Contact
Springfield Clinic
Contact: Site Public Contact
Springfield Memorial Hospital
Contact: Site Public Contact
Email: pallante.beth@mhsil.com
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
KY
Lexington
University of Kentucky/Markey Cancer Center
Contact: Site Public Contact
MD
Baltimore
University of Maryland/Greenebaum Cancer Center
Contact: Site Public Contact
Bethesda
National Institutes of Health Clinical Center
Contact: Site Public Contact
ME
Brewer
Lafayette Family Cancer Center-EMMC
Contact: Site Public Contact
MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health Medical Center - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health Medical Center - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Chelsea
Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Dearborn
Corewell Health Dearborn Hospital
Contact: Site Public Contact
Farmington Hills
Corewell Health Farmington Hills Hospital
Contact: Site Public Contact
Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org
Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org
Lansing
University of Michigan Health - Sparrow Lansing
Contact: Site Public Contact
Email: harsha.trivedi@umhsparrow.org
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Royal Oak
Corewell Health Children's
Contact: Site Public Contact
Corewell Health William Beaumont University Hospital
Contact: Site Public Contact
Saginaw
MyMichigan Medical Center Saginaw
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Tawas City
MyMichigan Medical Center Tawas
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Troy
Corewell Health Beaumont Troy Hospital
Contact: Site Public Contact
West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org
Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
MN
Deer River
Essentia Health - Deer River Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Duluth
Essentia Health Cancer Center
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Hibbing
Essentia Health Hibbing Clinic
Contact: Site Public Contact
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
Sandstone
Essentia Health Sandstone
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Virginia
Essentia Health Virginia Clinic
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
MO
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Louis
Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org
Bozeman
Bozeman Health Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Kalispell
Logan Health Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Missoula
Community Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact
NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu
NV
Henderson
OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org
NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org
Mineola
NYU Langone Hospital - Long Island
Contact: Site Public Contact
Email: cancertrials@nyulangone.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org
OH
Columbus
Columbus Oncology and Hematology Associates Inc
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Doctors Hospital
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Grant Medical Center
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Riverside Methodist Hospital
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Dayton
Dayton Physician LLC - Englewood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Delaware
Delaware Health Center-Grady Cancer Center
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Grady Memorial Hospital
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Dublin
Columbus Oncology and Hematology Associates
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Dublin Methodist Hospital
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Mansfield
OhioHealth Mansfield Hospital
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
Marion
OhioHealth Marion General Hospital
Contact: Site Public Contact
Email: Jennifer.Sexton@ohiohealth.com
OK
Oklahoma City
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
OR
Ontario
Saint Alphonsus Cancer Care Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
PA
Philadelphia
ECOG-ACRIN Cancer Research Group
Contact: Kristen Renee Spencer
Email: Kristen.Spencer@nyulangone.org
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu
Willow Grove
Asplundh Cancer Pavilion
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu
VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu
WA
Seattle
Swedish Medical Center-First Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
WI
Ashland
Duluth Clinic Ashland
Contact: Site Public Contact
Email: CancerTrials@EssentiaHealth.org
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org
Cudahy
Aurora Saint Luke's South Shore
Contact: Site Public Contact
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org
La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org
Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
PRIMARY OBJECTIVES: I. To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab as compared to AMG 510 (sotorasib) alone in patients with advanced/metastatic KRAS G12C mutated solid tumors (except colorectal carcinoma [CRC] and non-small cell lung carcinoma [NSCLC]) as measured by progression free survival (Cohort 1). II. To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab in patients with advanced/metastatic KRAS G12C mutated solid tumors that have progressed on a prior KRAS G12C inhibitor as measured by response rate (Cohort 2). SECONDARY OBJECTIVES: I. To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab as compared to AMG 510 alone in patients with advanced/metastatic KRAS G12C mutated solid tumors (except CRC and NSCLC) as measured by response rate, disease control rate, and overall survival (Cohort 1). II, To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab in patients with advanced/metastatic KRAS G12C mutated solid tumors that have progressed on a prior KRAS G12C inhibitor as measured by disease control rate, progression free survival (PFS), and overall survival (Cohort 2). III. To further evaluate the safety and tolerability of the combination of AMG 510 (sotorasib) and panitumumab. IV. To collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol. CORRELATIVE EXPLORATORY OBJECTIVES: I. To investigate the impact of concomitant mutations on the clinical benefit. II. To evaluate if changes in circulating tumor DNA (ctDNA) over time correlate with response to treatment. III. To evaluate the relative mutant allele fraction of KRAS mutation as a predictor of clinical benefit. IV. To evaluate if ERK 1/2 and PI3K pathway activation correlate with response and/or resistance. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients who have never received a KRAS G12C inhibitor are randomized to arms A or B. ARM A: Patients receive sotorasib orally (PO) once daily (QD) on days 1-28 and panitumumab intravenously (IV) on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and computed tomography (CT) or magnetic resonance imaging (MRI) on study. ARM B: Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study. COHORT II: Patients who have received a KRAS G12C inhibitor are assigned to arm C. ARM C: Patients receive combination therapy as in Arm A. After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 36 months.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network. This trial is part of the ComboMATCH precision medicine intiative.