RECRUITING

Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial

Conditions

Recurrent Endometrial Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma

Quick Navigation

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 selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.

Official Title

A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial

Quick Facts

Study Start:2023-04-25

Study Completion:2028-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05554328

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:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191 * Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191 * Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment * Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube ("ovarian") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1) * Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1). * Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy, if disease cannot be safely biopsied, or have archival tissue available from within 12 months prior to registration on the ComboMATCH Registration Trial (EAY191) * Patients must have progressed after first-line treatment for recurrent or persistent disease * Patients with ovarian cancer should not be eligible for further platinum-based therapy * Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib * Patients may have received unlimited prior therapy * Patients must have measurable and biopsiable disease. Measurable disease is defined by RECIST 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \> 10 mm when measured by CT, magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \> 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI * Patients must have at least one "target lesion" separate from the lesion to be biopsied to be used to assess response on this protocol as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Prior therapy must have been completed at least four weeks prior to registration * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 * Hemoglobin (Hgb) \>= 9.5 g/dL with no blood transfusion in the past 28 days (within 14 days prior to registration) * Platelets \>= 100,000/mcl (within 14 days prior to registration) * Absolute neutrophil count (ANC) \>= 1,500/mcl (within 14 days prior to registration) * Patients must have creatinine clearance estimated of \>= 50 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (within 14 days prior to registration) * Total bilirubin level =\< 1.5 x institutional upper limit of normal (ULN) or =\< 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) (within 14 days prior to registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to registration) * Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of selumetinib or olaparib * 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 * Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) during the study and for 12 weeks after completing treatment * Non-sterilized male partners of WOCBP (including males sterilized by a method other than bilateral orchidectomy e.g., vasectomy) who intend to be sexually active with a female partner must be using an acceptable method of contraception such as male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening throughout the total duration of the study and the drug washout period (at least 16 weeks after the last dose of study intervention) to prevent pregnancy in a partner. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Vasectomized (i.e., sterile) males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study * 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 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression * Extra caution should be taken with olaparib, as it crosses the blood brain barrier and can cause edema in brain metastases * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information	* Patients who have received any MEK inhibitors * Patients who have progressed while receiving a PARP inhibitor * Patients who have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia * Patients with uncontrolled intercurrent illness * Patients with \>= grade 2 neuropathy within 14 days of registration * Patients with severe (Child-Pugh C) liver dysfunction * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and selumetinib or any excipients thereof * Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents * Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E * Vitamin E must not be taken in the 7 days prior to initiation of treatment with selumetinib * Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or known moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, Fluconazole, verapamil). The required washout period prior to starting olaparib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication * Concomitant use of strong CYP2C19 inhibitors (e.g., ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole). The required washout period prior to starting selumetinib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication * Have received or are receiving an investigational medicinal product (IMP) or other systemic anti-cancer treatment (including chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) within 4 weeks prior to registration, or within a period during which the IMP or systemic target treatment has not been cleared from the body (e.g., a period of 5 'half-lives'), whichever is longer * Known myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) * Patients who have had previous organ transplant, allogenic bone marrow transplant or double umbilical cord blood transplantation * Patients who have had whole blood transfusion within 28 days prior to registration * Patients with ophthalmological conditions as follows: * Current or past history of retinal pigment epithelial detachment/central serous retinopathy or retinal vein occlusion. * Intraocular pressure \>21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of intraocular pressure \[IOP\]). Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair * Patients with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility * Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study * Patients with severe, active co-morbidity defined as any of the following: * History and/or confirmed pneumonitis * Uncontrolled hypertension (blood pressure \[BP\] \>= 150/90 mmHg despite medical therapy) * Acute coronary syndrome within 6 months prior to registration * Uncontrolled atrial fibrillation * Known family history of long QT syndrome * Women who are pregnant or unwilling to discontinue nursing

Inclusion Criteria

Exclusion Criteria

* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191
* Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191
* Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment
* Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube ("ovarian") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)
* Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1).
* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy, if disease cannot be safely biopsied, or have archival tissue available from within 12 months prior to registration on the ComboMATCH Registration Trial (EAY191)
* Patients must have progressed after first-line treatment for recurrent or persistent disease
* Patients with ovarian cancer should not be eligible for further platinum-based therapy
* Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib
* Patients may have received unlimited prior therapy
* Patients must have measurable and biopsiable disease. Measurable disease is defined by RECIST 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \> 10 mm when measured by CT, magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \> 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI
* Patients must have at least one "target lesion" separate from the lesion to be biopsied to be used to assess response on this protocol as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
* Prior therapy must have been completed at least four weeks prior to registration
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Hemoglobin (Hgb) \>= 9.5 g/dL with no blood transfusion in the past 28 days (within 14 days prior to registration)
* Platelets \>= 100,000/mcl (within 14 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1,500/mcl (within 14 days prior to registration)
* Patients must have creatinine clearance estimated of \>= 50 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (within 14 days prior to registration)
* Total bilirubin level =\< 1.5 x institutional upper limit of normal (ULN) or =\< 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) (within 14 days prior to registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to registration)
* Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of selumetinib or olaparib
* 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
* Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) during the study and for 12 weeks after completing treatment
* Non-sterilized male partners of WOCBP (including males sterilized by a method other than bilateral orchidectomy e.g., vasectomy) who intend to be sexually active with a female partner must be using an acceptable method of contraception such as male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening throughout the total duration of the study and the drug washout period (at least 16 weeks after the last dose of study intervention) to prevent pregnancy in a partner. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Vasectomized (i.e., sterile) males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study
* 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
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy
* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
* Extra caution should be taken with olaparib, as it crosses the blood brain barrier and can cause edema in brain metastases
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

* Patients who have received any MEK inhibitors
* Patients who have progressed while receiving a PARP inhibitor
* Patients who have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* Patients with uncontrolled intercurrent illness
* Patients with \>= grade 2 neuropathy within 14 days of registration
* Patients with severe (Child-Pugh C) liver dysfunction
* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and selumetinib or any excipients thereof
* Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
* Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
* Vitamin E must not be taken in the 7 days prior to initiation of treatment with selumetinib
* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or known moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, Fluconazole, verapamil). The required washout period prior to starting olaparib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication
* Concomitant use of strong CYP2C19 inhibitors (e.g., ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole). The required washout period prior to starting selumetinib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication
* Have received or are receiving an investigational medicinal product (IMP) or other systemic anti-cancer treatment (including chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) within 4 weeks prior to registration, or within a period during which the IMP or systemic target treatment has not been cleared from the body (e.g., a period of 5 'half-lives'), whichever is longer
* Known myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Patients who have had previous organ transplant, allogenic bone marrow transplant or double umbilical cord blood transplantation
* Patients who have had whole blood transfusion within 28 days prior to registration
* Patients with ophthalmological conditions as follows:
* Current or past history of retinal pigment epithelial detachment/central serous retinopathy or retinal vein occlusion.
* Intraocular pressure \>21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of intraocular pressure \[IOP\]). Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair
* Patients with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility
* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
* Patients with severe, active co-morbidity defined as any of the following:
* History and/or confirmed pneumonitis
* Uncontrolled hypertension (blood pressure \[BP\] \>= 150/90 mmHg despite medical therapy)
* Acute coronary syndrome within 6 months prior to registration
* Uncontrolled atrial fibrillation
* Known family history of long QT syndrome
* Women who are pregnant or unwilling to discontinue nursing

Contacts and Locations

Principal Investigator

Shannon N Westin

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

CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338

United States

Kingman Regional Medical Center

Kingman, Arizona, 86401

United States

PCR Oncology

Arroyo Grande, California, 93420

United States

Saint Joseph Hospital - Orange

Orange, California, 92868

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

Presbyterian Intercommunity Hospital

Whittier, California, 90602

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

The Queen's Medical Center - West Oahu

'Ewa Beach, Hawaii, 96706

United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813

United States

Queen's Medical Center

Honolulu, Hawaii, 96813

United States

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813

United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

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

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

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

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

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

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

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

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412

United States

Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

United States

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

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

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116

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

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

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

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

United States

Essentia Health Cancer Center

Duluth, Minnesota, 55805

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

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

Washington University School of Medicine

Saint Louis, Missouri, 63110

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

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, 08080

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

State University of New York Upstate Medical University

Syracuse, New York, 13210

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, 27607

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122

United States

Strecker Cancer Center-Belpre

Belpre, Ohio, 45714

United States

Aultman Health Foundation

Canton, Ohio, 44710

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Adena Regional Medical Center

Chillicothe, Ohio, 45601

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Mount Carmel East Hospital

Columbus, Ohio, 43213

United States

Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

The Mark H Zangmeister Center

Columbus, Ohio, 43219

United States

Miami Valley Hospital

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

Fairfield Medical Center

Lancaster, Ohio, 43130

United States

Marietta Memorial Hospital

Marietta, Ohio, 45750

United States

Memorial Hospital

Marysville, Ohio, 43040

United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060

United States

Knox Community Hospital

Mount Vernon, Ohio, 43050

United States

Licking Memorial Hospital

Newark, Ohio, 43055

United States

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, 43551

United States

Southern Ohio Medical Center

Portsmouth, Ohio, 45662

United States

Springfield Regional Cancer Center

Springfield, Ohio, 45504

United States

Springfield Regional Medical Center

Springfield, Ohio, 45504

United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, 43623

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

Saint Ann's Hospital

Westerville, Ohio, 43081

United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

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

Riddle Memorial Hospital

Media, Pennsylvania, 19063

United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

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

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

Women and Infants Hospital

Providence, Rhode Island, 02905

United States

Rapid City Regional Hospital

Rapid City, South Dakota, 57701

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

MD Anderson in The Woodlands

Conroe, Texas, 77384

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

MD Anderson West Houston

Houston, Texas, 77079

United States

MD Anderson League City

League City, Texas, 77573

United States

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

United States

Virginia Cancer Institute

Richmond, Virginia, 23229

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24016

United States

VCU Community Memorial Health Center

South Hill, Virginia, 23970

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

United States

Valley Medical Center

Renton, Washington, 98055

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902

United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701

United States

West Virginia University Healthcare

Morgantown, West Virginia, 26506

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

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

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

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

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)

Shannon N Westin, 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 Date2023-04-25

Study Completion Date2028-10-01

Study Record Updates

Study Start Date2023-04-25

Study Completion Date2028-10-01

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma