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.
Описание
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:
Кой може да участва
Inclusion Criteria:
* 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 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
Интервенции
Biopsy Procedure
PROCEDURE
Biospecimen Collection
PROCEDURE
Computed Tomography
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Panitumumab
BIOLOGICAL
Sotorasib
DRUG
Места на провеждане
182
САЩ (182)
University of New Mexico Cancer Center
Albuquerque , New Mexico
Community Hospital of Anaconda
Anaconda , Montana
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny , Iowa
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor , Michigan
ThedaCare Regional Cancer Center
Appleton , Wisconsin
Duluth Clinic Ashland
Ashland , Wisconsin
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura , Florida
University of Maryland/Greenebaum Cancer Center
Baltimore , Maryland
Advocate Good Shepherd Hospital
Barrington , Illinois
ThedaCare Cancer Care - Berlin
Berlin , Wisconsin
Walter Reed National Military Medical Center
Bethesda , Maryland
National Institutes of Health Clinical Center
Bethesda , Maryland
Billings Clinic Cancer Center
Billings , Montana
University of Alabama at Birmingham Cancer Center
Birmingham , Alabama
Prisma Health Cancer Institute - Spartanburg
Boiling Springs , South Carolina
Saint Alphonsus Cancer Care Center-Boise
Boise , Idaho
Saint Luke's Cancer Institute - Boise
Boise , Idaho
Bozeman Health Deaconess Hospital
Bozeman , Montana
Lafayette Family Cancer Center-EMMC
Brewer , Maine
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton , Michigan
Trinity Health Medical Center - Brighton
Brighton , Michigan
Bristol Regional Medical Center
Bristol , Tennessee
Ballad Health Cancer Care - Bristol
Bristol , Virginia
Roswell Park Cancer Institute
Buffalo , New York
Aurora Cancer Care-Southern Lakes VLCC
Burlington , Wisconsin
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell , Idaho
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton , Michigan
Trinity Health Medical Center - Canton
Canton , Michigan
Saint Francis Medical Center
Cape Girardeau , Missouri
West Virginia University Charleston Division
Charleston , West Virginia
University of Virginia Cancer Center
Charlottesville , Virginia
Chelsea Hospital
Chelsea , Michigan
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea , Michigan
John H Stroger Jr Hospital of Cook County
Chicago , Illinois
University of Illinois
Chicago , Illinois
Advocate Illinois Masonic Medical Center
Chicago , Illinois
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters , Missouri
Kootenai Health - Coeur d'Alene
Coeur d'Alene , Idaho
Columbus Oncology and Hematology Associates Inc
Columbus , Ohio
Riverside Methodist Hospital
Columbus , Ohio
Grant Medical Center
Columbus , Ohio
Doctors Hospital
Columbus , Ohio
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables , Florida
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs , Florida
Siteman Cancer Center at West County Hospital
Creve Coeur , Missouri
AMG Crystal Lake - Oncology
Crystal Lake , Illinois
Aurora Saint Luke's South Shore
Cudahy , Wisconsin
Carle at The Riverfront
Danville , Illinois
Dayton Physician LLC - Englewood
Dayton , Ohio
Corewell Health Dearborn Hospital
Dearborn , Michigan
Cancer Care Specialists of Illinois - Decatur
Decatur , Illinois
Decatur Memorial Hospital
Decatur , Illinois
Essentia Health - Deer River Clinic
Deer River , Minnesota
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach , Florida
Delaware Health Center-Grady Cancer Center
Delaware , Ohio
Grady Memorial Hospital
Delaware , Ohio
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines , Iowa
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines , Iowa
Advocate Good Samaritan Hospital
Downers Grove , Illinois
Columbus Oncology and Hematology Associates
Dublin , Ohio
Dublin Methodist Hospital
Dublin , Ohio
Essentia Health Cancer Center
Duluth , Minnesota
Prisma Health Cancer Institute - Easley
Easley , South Carolina
Carle Physician Group-Effingham
Effingham , Illinois
Crossroads Cancer Center
Effingham , Illinois
Advocate Sherman Hospital
Elgin , Illinois
Corewell Health Farmington Hills Hospital
Farmington Hills , Michigan
Cancer Hematology Centers - Flint
Flint , Michigan
Genesee Hematology Oncology PC
Flint , Michigan
Genesys Hurley Cancer Institute
Flint , Michigan
Hurley Medical Center
Flint , Michigan
Saint Luke's Cancer Institute - Fruitland
Fruitland , Idaho
Aurora Health Care Germantown Health Center
Germantown , Wisconsin
Aurora Cancer Care-Grafton
Grafton , Wisconsin
Benefis Sletten Cancer Institute
Great Falls , Montana
Aurora BayCare Medical Center
Green Bay , Wisconsin
Prisma Health Cancer Institute - Butternut
Greenville , South Carolina
Prisma Health Cancer Institute - Faris
Greenville , South Carolina
Prisma Health Cancer Institute - Eastside
Greenville , South Carolina
Prisma Health Cancer Institute - Greer
Greer , South Carolina
Advocate South Suburban Hospital
Hazel Crest , Illinois
OptumCare Cancer Care at Seven Hills
Henderson , Nevada
Essentia Health Hibbing Clinic
Hibbing , Minnesota
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood , Florida
Mayo Clinic in Florida
Jacksonville , Florida
Mercyhealth Hospital and Cancer Center - Janesville
Janesville , Wisconsin
Regional Cancer Center at Johnson City Medical Center
Johnson City , Tennessee
Logan Health Medical Center
Kalispell , Montana
Aurora Cancer Care-Kenosha South
Kenosha , Wisconsin
Kettering Medical Center
Kettering , Ohio
Ballad Health Cancer Care - Kingsport
Kingsport , Tennessee
Wellmont Holston Valley Hospital and Medical Center
Kingsport , Tennessee
Gundersen Lutheran Medical Center
La Crosse , Wisconsin
University of Michigan Health - Sparrow Lansing
Lansing , Michigan
OptumCare Cancer Care at Charleston
Las Vegas , Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas , Nevada
OptumCare Cancer Care at Fort Apache
Las Vegas , Nevada
University of Kentucky/Markey Cancer Center
Lexington , Kentucky
AMG Libertyville - Oncology
Libertyville , Illinois
Condell Memorial Hospital
Libertyville , Illinois
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia , Michigan
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles , California
Cedars Sinai Medical Center
Los Angeles , California
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison , Wisconsin
University of Wisconsin Carbone Cancer Center - University Hospital
Madison , Wisconsin
OhioHealth Mansfield Hospital
Mansfield , Ohio
Aurora Bay Area Medical Group-Marinette
Marinette , Wisconsin
OhioHealth Marion General Hospital
Marion , Ohio
Carle Physician Group-Mattoon/Charleston
Mattoon , Illinois
Loyola University Medical Center
Maywood , Illinois
Saint Luke's Cancer Institute - Meridian
Meridian , Idaho
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami , Florida
UM Sylvester Comprehensive Cancer Center at Kendall
Miami , Florida
Aurora Cancer Care-Milwaukee
Milwaukee , Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee , Wisconsin
Aurora Sinai Medical Center
Milwaukee , Wisconsin
NYU Langone Hospital - Long Island
Mineola , New York
Community Medical Center
Missoula , Montana
University of South Alabama Mitchell Cancer Institute
Mobile , Alabama
Saint Alphonsus Cancer Care Center-Nampa
Nampa , Idaho
Saint Luke's Cancer Institute - Nampa
Nampa , Idaho
Vanderbilt University/Ingram Cancer Center
Nashville , Tennessee
ThedaCare Regional Medical Center - Neenah
Neenah , Wisconsin
Rutgers Cancer Institute of New Jersey
New Brunswick , New Jersey
ThedaCare Cancer Care - New London
New London , Wisconsin
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York , New York
Carle BroMenn Medical Center
Normal , Illinois
Carle Cancer Institute Normal
Normal , Illinois
Cancer Care Center of O'Fallon
O'Fallon , Illinois
Advocate Christ Medical Center
Oak Lawn , Illinois
Advocate Outpatient Center - Oak Lawn
Oak Lawn , Illinois
University of Oklahoma Health Sciences Center
Oklahoma City , Oklahoma
Saint Alphonsus Cancer Care Center-Ontario
Ontario , Oregon
ThedaCare Cancer Care - Oshkosh
Oshkosh , Wisconsin
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh , Wisconsin
VA Palo Alto Health Care System
Palo Alto , California
Advocate High Tech Medical Park
Palos Heights , Illinois
Advocate Lutheran General Hospital
Park Ridge , Illinois
ECOG-ACRIN Cancer Research Group
Philadelphia , Pennsylvania
Thomas Jefferson University Hospital
Philadelphia , Pennsylvania
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation , Florida
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac , Michigan
Providence Portland Medical Center
Portland , Oregon
Providence Saint Vincent Medical Center
Portland , Oregon
Kootenai Clinic Cancer Services - Post Falls
Post Falls , Idaho
Aurora Cancer Care-Racine
Racine , Wisconsin
Rapid City Regional Hospital
Rapid City , South Dakota
VCU Massey Cancer Center at Stony Point
Richmond , Virginia
VCU Massey Comprehensive Cancer Center
Richmond , Virginia
Mayo Clinic in Rochester
Rochester , Minnesota
Corewell Health Children's
Royal Oak , Michigan
Corewell Health William Beaumont University Hospital
Royal Oak , Michigan
MyMichigan Medical Center Saginaw
Saginaw , Michigan
Oncology Hematology Associates of Saginaw Valley PC
Saginaw , Michigan
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint , Idaho
Essentia Health Sandstone
Sandstone , Minnesota
Swedish Medical Center-First Hill
Seattle , Washington
Prisma Health Cancer Institute - Seneca
Seneca , South Carolina
ThedaCare Cancer Care - Shawano
Shawano , Wisconsin
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan , Wisconsin
Memorial Hospital East
Shiloh , Illinois
Southern Illinois University School of Medicine
Springfield , Illinois
Springfield Clinic
Springfield , Illinois
Springfield Memorial Hospital
Springfield , Illinois
Washington University School of Medicine
St Louis , Missouri
Siteman Cancer Center-South County
St Louis , Missouri
Siteman Cancer Center at Christian Hospital
St Louis , Missouri
Aurora Medical Center in Summit
Summit , Wisconsin
MyMichigan Medical Center Tawas
Tawas City , Michigan
Scott and White Memorial Hospital
Temple , Texas
Corewell Health Beaumont Troy Hospital
Troy , Michigan
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers , Wisconsin
Carle Cancer Center
Urbana , Illinois
Essentia Health Virginia Clinic
Virginia , Minnesota
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee , Iowa
ThedaCare Cancer Care - Waupaca
Waupaca , Wisconsin
Aurora Cancer Care-Milwaukee West
Wauwatosa , Wisconsin
Aurora West Allis Medical Center
West Allis , Wisconsin
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch , Michigan
Asplundh Cancer Pavilion
Willow Grove , Pennsylvania
Huron Gastroenterology PC
Ypsilanti , Michigan
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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