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Résztvevőt keres itt: Egyesült Államok2. fázis

Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma

A legfontosabb adatok

Ki végzi
National Cancer Institute (NCI)
Hol
Albuquerque, Anaconda, Ashland, Athens, Augusta, Battle Creek, Beachwood, Beaver, Billings, Birmingham, Boise, Bozeman, Buffalo, Butler, Caldwell, Carmel, Centerville, Chardon, Charlottesville, Chicago, Cincinnati, Cleveland, Coeur d'Alene, Columbia, Columbus, Coon Rapids, Cranberry Township, Crown Point, Dallas, Danville, Deer River, Duluth, Durham, Dyer, Edina, Edmonds, Effingham, Erie, Fargo, Farrell, Fort Worth, Fruitland, Grand Rapids, Great Falls, Greensburg, Hibbing, Hobart, Indiana, Indianapolis, Iowa City, Issaquah, Johnstown, Kalamazoo, Kalispell, Las Vegas, Louisville, Mattoon, Mayfield Heights, McKeesport, Mechanicsburg, Mentor, Meridian, Minneapolis, Missoula, Monroeville, Moon Township, Mount Pleasant, Munster, Muskegon, N. Huntingdon, Nampa, Natrona Heights, New Castle, Niles, Normal, Norton Shores, Oklahoma City, Omaha, Ontario, Parma, Pittsburgh, Portland, Post Falls, Providence, Raleigh, Reed City, Richardson, Richmond, Rochester, Saint Joseph, Saint Louis Park, Saint Paul, Sandpoint, Sandstone, Scarborough, Seattle, Seneca, Shakopee, St Louis, Syracuse, Traverse City, Tulsa, Urbana, Valparaiso, Virginia, Washington, Webster, West Mifflin, Westlake és Wyoming (Egyesült Államok)Mind a 138 helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
2. fázis
Résztvevők
81 fő, tervezett
Kezdés
2022. jún. 2.
Várható befejezés
2032. júl. 30.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Biospecimen Collection
  • Computed Tomography
  • Ipilimumab
  • Magnetic Resonance Imaging
  • Nivolumab
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtt nőket keres, akiknek a méhnyálkahártya-rákja kiújult, és hibás a DNS-hibajavító rendszere (dMMR). A nivolumab és ipilimumab együttes adását hasonlítja a csak nivolumabbal.

Életkor
18 éves vagy idősebb
Nem
Csak nők
A betegség stádiuma
Kiújult méhnyálkahártya-rák, amely mérhető, vagy csak a képalkotó vizsgálaton látható. Megengedett típusok: endometrioid, mucinosus, dedifferenciált/differenciálatlan, világossejtes, kevert hámeredetű, vagy közelebbről nem meghatározott adenocarcinoma.
Korábbi kezelés
Korábban 1-2 sor gyógyszeres kezelést kaphatott. Korábbi anti-PD1/PD-L1 kezelés csak kemoterápiával vagy sugárkezeléssel együtt megengedett, teljes remisszió után, legalább 12 hónapos kezelésmentes idővel. A korábbi sugár-, hormon- és egyéb daganatellenes kezelésnek 3-6 héttel a csatlakozás előtt be kellett fejeződnie. Korábbi anti-CTLA-4 vagy más immunterápia nem megengedett.
Biomarker vagy leletérték
A daganatnak hibás DNS-hibajavító rendszerrel (dMMR) kell rendelkeznie: hiányzik egy vagy több MMR-fehérje (MLH1, PMS2, MSH2, MSH6, EPCAM), vagy magas a mikroszatellita-instabilitás (MSI).

A részvétel fő kizáró okai

  • A méhnyálkahártya szerózus carcinomája vagy carcinosarcomája
  • Korábbi anti-CTLA-4 vagy más immunterápia, illetve súlyos mellékhatás korábbi anti-PD1/PD-L1 kezelés mellett
  • Tartós szteroidkezelés vagy más immunszuppresszív kezelés
  • Aktív vagy korábbi autoimmun betegség, amely kiújulhat
  • Terhesség vagy szoptatás

A regiszter feltételei, szó szerint

Mind a 40 feltétel megnézéseKevesebb

Ki vehet részt

  • Patients with measurable or non-measurable (detectable) recurrent endometrial cancer
  • Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria 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 computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:; All other lesions (or sites of disease), including small lesions (longest diameter <10 mm or pathological lymph nodes with >= 10 to < 15 mm short axis), are considered non-measurable disease; Ascites and/or pleural effusion attributed to tumor; Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
  • Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing [NGS] panel); Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results
  • Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
  • Patients may have received 1-2 prior lines of systemic therapy:; Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition
  • Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration
  • Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration
  • Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Platelets >= 100,000/mcl
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN)
  • Total serum bilirubin level =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =<3 x ULN may be enrolled)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN
  • Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia < grade 2 within 28 days prior to registration)
  • Thyroid-stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated
  • Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery
  • As clinically indicated, 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 and have a corrected QT (QTc) interval < 450 msec
  • The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception; WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
  • 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month
  • 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 with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

Ki nem vehet részt

  • Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities
  • Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
  • Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent
  • Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Patients on immunosuppressive therapy, with the exception of:; Intra-nasal, inhaled, topical or local steroid injections; Premedication for hypersensitivity reaction
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease
  • Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
  • Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody
  • Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
  • Women who are pregnant or unwilling to discontinue nursing

Helyszínek itt: Egyesült Államok

  • University of New Mexico Cancer CenterAlbuquerque, Egyesült ÁllamokContact: Carolyn Y. Muller (principal investigator)Résztvevőt keres
  • Community Hospital of AnacondaAnaconda, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • Duluth Clinic AshlandAshland, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • Northwest Wisconsin Cancer CenterAshland, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • University Cancer And Blood Center LLCAthens, Egyesült ÁllamokNo longer taking part
  • Augusta University Medical CenterAugusta, Egyesült ÁllamokContact: Bunja J. Rungruang (principal investigator)Résztvevőt keres
  • Bronson Battle CreekBattle Creek, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • UHHS-Chagrin Highlands Medical CenterBeachwood, Egyesült ÁllamokContact: Amy Armstrong (principal investigator)Résztvevőt keres
  • UPMC-Heritage Valley Health System BeaverBeaver, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Billings Clinic Cancer CenterBillings, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • Intermountain Health West End ClinicBillings, Egyesült ÁllamokContact: Megan Petersen (principal investigator)Résztvevőt keres
  • Saint Vincent Frontier Cancer CenterBillings, Egyesült ÁllamokContact: Megan Petersen (principal investigator)Résztvevőt keres
  • University of Alabama at Birmingham Cancer CenterBirmingham, Egyesült ÁllamokContact: Michael D. Toboni (principal investigator)Résztvevőt keres
  • Saint Luke's Cancer Institute - BoiseBoise, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Saint Alphonsus Cancer Care Center-BoiseBoise, Egyesült ÁllamokNo longer taking part
  • Bozeman Health Deaconess HospitalBozeman, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • Roswell Park Cancer InstituteBuffalo, Egyesült ÁllamokNo longer taking part
  • UPMC Hillman Cancer Center at Butler Health SystemButler, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Saint Alphonsus Cancer Care Center-CaldwellCaldwell, Egyesült ÁllamokNo longer taking part
  • IU Health North HospitalCarmel, Egyesült ÁllamokNo longer taking part
  • Miami Valley Hospital SouthCenterville, Egyesült ÁllamokContact: Michael S. Guy (principal investigator)Résztvevőt keres
  • Geauga HospitalChardon, Egyesült ÁllamokContact: Amy Armstrong (principal investigator)Résztvevőt keres
  • University of Virginia Cancer CenterCharlottesville, Egyesült ÁllamokContact: Linda R. Duska (principal investigator)Résztvevőt keres
  • University of IllinoisChicago, Egyesült ÁllamokNo longer taking part
  • Good Samaritan Hospital - CincinnatiCincinnati, Egyesült ÁllamokNo longer taking part
  • Case Western Reserve UniversityCleveland, Egyesült ÁllamokContact: Amy Armstrong (principal investigator)Résztvevőt keres
  • Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Egyesült ÁllamokContact: Peter G. Rose (principal investigator)Résztvevőt keres
  • Cleveland Clinic FoundationCleveland, Egyesült ÁllamokContact: Peter G. Rose (principal investigator)Résztvevőt keres
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • MU Health - University Hospital/Ellis Fischel Cancer CenterColumbia, Egyesült ÁllamokContact: Arwa M. Mohammad (principal investigator)Résztvevőt keres
  • Ohio State University Comprehensive Cancer CenterColumbus, Egyesült ÁllamokContact: Floor Backes (principal investigator)Résztvevőt keres
  • Mercy HospitalCoon Rapids, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center - Passavant - CranberryCranberry Township, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Northwest Cancer Center - Crown PointCrown Point, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Parkland Memorial HospitalDallas, Egyesült ÁllamokContact: David S. Miller (principal investigator)Résztvevőt keres
  • UT Southwestern/Simmons Cancer Center-DallasDallas, Egyesült ÁllamokContact: David S. Miller (principal investigator)Résztvevőt keres
  • Carle at The RiverfrontDanville, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Essentia Health - Deer River ClinicDeer River, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • Essentia Health Cancer CenterDuluth, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • Miller-Dwan HospitalDuluth, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • Duke University Medical CenterDurham, Egyesült ÁllamokContact: Angeles A. Secord (principal investigator)Résztvevőt keres
  • Northwest Oncology LLCDyer, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Fairview Southdale HospitalEdina, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • Minnesota Oncology - EdinaEdina, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • Swedish Cancer Institute-EdmondsEdmonds, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Carle Physician Group-EffinghamEffingham, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center ErieErie, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Essentia Health Cancer Center-South University ClinicFargo, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • UPMC Cancer Center at UPMC HorizonFarrell, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Cancer Institute - FruitlandFruitland, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Trinity Health Grand Rapids HospitalGrand Rapids, Egyesült ÁllamokNo longer taking part
  • Benefis Sletten Cancer InstituteGreat Falls, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • UPMC Cancer Centers - Arnold Palmer PavilionGreensburg, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Essentia Health Hibbing ClinicHibbing, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • Northwest Cancer Center - HobartHobart, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Saint Mary Medical CenterHobart, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • IRMC Cancer CenterIndiana, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, Egyesült ÁllamokContact: Jessica E. Parker (principal investigator)Résztvevőt keres
  • Saint Catherine HospitalIndianapolis, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, Egyesült ÁllamokContact: David P. Bender (principal investigator)Résztvevőt keres
  • Swedish Cancer Institute-IssaquahIssaquah, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • UPMC-Johnstown/John P. Murtha Regional Cancer CenterJohnstown, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Beacon Kalamazoo Cancer CenterKalamazoo, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Bronson Methodist HospitalKalamazoo, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • West Michigan Cancer CenterKalamazoo, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Logan Health Medical CenterKalispell, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • Women's Cancer Center of NevadaLas Vegas, Egyesült ÁllamokContact: Nicola M. Spirtos (principal investigator)Résztvevőt keres
  • The James Graham Brown Cancer Center at University of LouisvilleLouisville, Egyesült ÁllamokContact: Jason A. Chesney (principal investigator)Résztvevőt keres
  • UofL Health Medical Center NortheastLouisville, Egyesült ÁllamokContact: Jason A. Chesney (principal investigator)Résztvevőt keres
  • Carle Physician Group-Mattoon/CharlestonMattoon, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Hillcrest Hospital Cancer CenterMayfield Heights, Egyesült ÁllamokContact: Peter G. Rose (principal investigator)Résztvevőt keres
  • UPMC Cancer Center at UPMC McKeesportMcKeesport, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionMechanicsburg, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UH Seidman Cancer Center at Lake Health Mentor CampusMentor, Egyesült ÁllamokContact: Amy Armstrong (principal investigator)Résztvevőt keres
  • Saint Luke's Cancer Institute - MeridianMeridian, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Abbott-Northwestern HospitalMinneapolis, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • Community Medical CenterMissoula, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center - MonroevilleMonroeville, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center in CoraopolisMoon Township, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center - Part of Frick HospitalMount Pleasant, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • The Community HospitalMunster, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Women's Diagnostic Center - MunsterMunster, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Trinity Health Muskegon HospitalMuskegon, Egyesült ÁllamokNo longer taking part
  • Arnold Palmer Cancer Center Medical Oncology NorwinN. Huntingdon, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Saint Luke's Cancer Institute - NampaNampa, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Saint Alphonsus Cancer Care Center-NampaNampa, Egyesült ÁllamokNo longer taking part
  • UPMC Cancer Center-Natrona HeightsNatrona Heights, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer Center - New CastleNew Castle, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Carle BroMenn Medical CenterNormal, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Carle Cancer Institute NormalNormal, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, Egyesült ÁllamokNo longer taking part
  • University of Oklahoma Health Sciences CenterOklahoma City, Egyesült ÁllamokContact: Christina Washington (principal investigator)Résztvevőt keres
  • Nebraska Methodist HospitalOmaha, Egyesült ÁllamokContact: Brent J. Tierney (principal investigator)Résztvevőt keres
  • Saint Alphonsus Cancer Care Center-OntarioOntario, Egyesült ÁllamokNo longer taking part
  • University Hospitals Parma Medical CenterParma, Egyesült ÁllamokContact: Amy Armstrong (principal investigator)Résztvevőt keres
  • UPMC Hillman Cancer CenterPittsburgh, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC-Magee Womens HospitalPittsburgh, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC-Mercy HospitalPittsburgh, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC-Passavant HospitalPittsburgh, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC-Saint Clair Hospital Cancer CenterPittsburgh, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UPMC-Saint MargaretPittsburgh, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Providence Portland Medical CenterPortland, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Providence Saint Vincent Medical CenterPortland, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • Women and Infants HospitalProvidence, Egyesült ÁllamokContact: Cara A. Mathews (principal investigator)Résztvevőt keres
  • Duke Women's Cancer Care RaleighRaleigh, Egyesült ÁllamokContact: Angeles A. Secord (principal investigator)Résztvevőt keres
  • Corewell Health Reed City HospitalReed City, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • UT Southwestern Clinical Center at Richardson/PlanoRichardson, Egyesült ÁllamokContact: David S. Miller (principal investigator)Résztvevőt keres
  • Henrico Doctor's HospitalRichmond, Egyesült ÁllamokContact: Andrew S. Kennedy (principal investigator)Résztvevőt keres
  • VCU Massey Comprehensive Cancer CenterRichmond, Egyesült ÁllamokNo longer taking part
  • University of RochesterRochester, Egyesült ÁllamokContact: Rachael Turner (principal investigator)Résztvevőt keres
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • Regions HospitalSaint Paul, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • United HospitalSaint Paul, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • Kootenai Clinic Cancer Services - SandpointSandpoint, Egyesült ÁllamokContact: John M. Schallenkamp (principal investigator)Résztvevőt keres
  • Essentia Health SandstoneSandstone, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • MaineHealth Maine Medical Center- ScarboroughScarborough, Egyesült ÁllamokContact: Leslie S. Bradford (principal investigator)Résztvevőt keres
  • Swedish Medical Center-First HillSeattle, Egyesült ÁllamokContact: Dan S. Zuckerman (principal investigator)Résztvevőt keres
  • Fred Hutchinson Cancer CenterSeattle, Egyesült ÁllamokNo longer taking part
  • UPMC Cancer Center at UPMC NorthwestSeneca, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Saint Francis Regional Medical CenterShakopee, Egyesült ÁllamokContact: Adrianne Mallen (principal investigator)Résztvevőt keres
  • Washington University School of MedicineSt Louis, Egyesült ÁllamokContact: Premal H. Thaker (principal investigator)Résztvevőt keres
  • State University of New York Upstate Medical UniversitySyracuse, Egyesült ÁllamokContact: Mary J. Cunningham (principal investigator)Résztvevőt keres
  • Munson Medical CenterTraverse City, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres
  • Oklahoma Cancer Specialists and Research Institute-TulsaTulsa, Egyesült ÁllamokNo longer taking part
  • Carle Cancer CenterUrbana, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Northwest Cancer Center - ValparaisoValparaiso, Egyesült ÁllamokContact: Pratima Chalasani (principal investigator)Résztvevőt keres
  • Essentia Health Virginia ClinicVirginia, Egyesült ÁllamokContact: Bret E. Friday (principal investigator)Résztvevőt keres
  • UPMC Cancer Center-WashingtonWashington, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • Wilmot Cancer Institute at WebsterWebster, Egyesült ÁllamokContact: Rachael Turner (principal investigator)Résztvevőt keres
  • UPMC West Mifflin-Cancer Center JeffersonWest Mifflin, Egyesült ÁllamokContact: Alexander B. Olawaiye (principal investigator)Résztvevőt keres
  • UH Seidman Cancer Center at Saint John Medical CenterWestlake, Egyesült ÁllamokContact: Amy Armstrong (principal investigator)Résztvevőt keres
  • University of Michigan Health - WestWyoming, Egyesült ÁllamokContact: Kathleen Y. Butler (principal investigator)Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.

A vizsgálat 2 csoportja

  • Arm I (nivolumab and ipilimumab)A vizsgált kezelés

    Patients receive nivolumab IV over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or CR. Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR. MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.

    Kezelés: Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging és Nivolumab

  • Arm II (nivolumab)Már használt kezelés, összehasonlításként

    Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR. MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.

    Kezelés: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging és Nivolumab

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients With Deficient Mismatch Repair System Recurrent Endometrial Carcinoma
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. november 12.