Recruiting
Phase 2

Nivolumab & Ipilimumab

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05112601

Conditions

Endometrial Adenocarcinoma

Endometrial Clear Cell Adenocarcinoma

Endometrial Dedifferentiated Carcinoma

Endometrial Endometrioid Adenocarcinoma

Endometrial Mixed Cell Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Ipilimumab

Magnetic Resonance Imaging

Nivolumab

Study Details

Brief summary:

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.

Conditions

Endometrial Adenocarcinoma

Endometrial Clear Cell Adenocarcinoma

Endometrial Dedifferentiated Carcinoma

Endometrial Endometrioid Adenocarcinoma

Endometrial Mixed Cell Adenocarcinoma

Study ID

NCT05112601

Start date

Jun 2, 2022

Status verified date

Jun, 2026

Completion date

Jul 30, 2032

Anticipated

Primary completion date

Jul 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
  • 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
  • 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
  • Women who are pregnant or unwilling to discontinue nursing
  • Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • 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

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (nivolumab and ipilimumab)

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.

active comparator: Arm II (nivolumab)

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.

Interventions

Biospecimen Collection

Undergo collection of tissue and/or blood samples

Computed Tomography

Undergo CT

Ipilimumab

Given IV

Magnetic Resonance Imaging

Undergo MRI

Nivolumab

Given IV

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years after randomization ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Michael D. Toboni

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Site Public Contact

706-721-2388ga_cares@augusta.edu

Principal Investigator:

Bunja J. Rungruang

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Pratima Chalasani

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Pratima Chalasani

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Pratima Chalasani

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Pratima Chalasani

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Pratima Chalasani

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Pratima Chalasani

Northwest Cancer Center - Crown Point

Recruiting

Crown Point, Indiana, United States, 46307

Contacts

Site Public Contact

219-836-6879CancerResearch@powershealth.org

Principal Investigator:

Pratima Chalasani

Northwest Oncology LLC

Recruiting

Dyer, Indiana, United States, 46311

Contacts

Site Public Contact

219-924-8178

Principal Investigator:

Pratima Chalasani

Northwest Cancer Center - Hobart

Recruiting

Hobart, Indiana, United States, 46342

Contacts

Site Public Contact

219-947-1795

Principal Investigator:

Pratima Chalasani

Saint Mary Medical Center

Recruiting

Hobart, Indiana, United States, 46342

Contacts

Site Public Contact

219-836-6875CancerResearch@COMHS.org

Principal Investigator:

Pratima Chalasani

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Jessica E. Parker

Saint Catherine Hospital

Recruiting

Indianapolis, Indiana, United States, 46312

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Pratima Chalasani

The Community Hospital

Recruiting

Munster, Indiana, United States, 46321

Contacts

Site Public Contact

219-836-3349

Principal Investigator:

Pratima Chalasani

Women's Diagnostic Center - Munster

Recruiting

Munster, Indiana, United States, 46321

Contacts

Site Public Contact

219-934-8869mnicholson@comhs.org

Principal Investigator:

Pratima Chalasani

Northwest Cancer Center - Valparaiso

Recruiting

Valparaiso, Indiana, United States, 46383

Contacts

Site Public Contact

219-836-6875CancerResearch@COMHS.org

Principal Investigator:

Pratima Chalasani

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

David P. Bender

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Jason A. Chesney

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Site Public Contact

502-852-2755ctoinfo@louisville.edu

Principal Investigator:

Jason A. Chesney

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Site Public Contact

207-396-8670clinicalresearch@mainehealth.org

Principal Investigator:

Leslie S. Bradford

Bronson Battle Creek

Recruiting

Battle Creek, Michigan, United States, 49017

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Beacon Kalamazoo Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49009

Contacts

Site Public Contact

574-647-7370

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Niles Hospital

Recruiting

Niles, Michigan, United States, 49120

Contacts

Site Public Contact

616-391-1230

Principal Investigator:

Kathleen Y. Butler

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Essentia Health - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Miller-Dwan Hospital

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Minnesota Oncology - Edina

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Saint Francis Regional Medical Center

Recruiting

Shakopee, Minnesota, United States, 55379

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Adrianne Mallen

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

MU Health - University Hospital/Ellis Fischel Cancer Center

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Site Public Contact

573-882-7440

Principal Investigator:

Arwa M. Mohammad

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Premal H. Thaker

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Saint Vincent Frontier Cancer Center

Recruiting

Billings, Montana, United States, 59102

Contacts

Site Public Contact

800-648-6274

Principal Investigator:

Megan Petersen

Intermountain Health West End Clinic

Recruiting

Billings, Montana, United States, 59106

Contacts

Site Public Contact

406-238-6685

Principal Investigator:

Megan Petersen

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-354-5144

Principal Investigator:

Brent J. Tierney

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Site Public Contact

702-851-4672

Principal Investigator:

Nicola M. Spirtos

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Carolyn Y. Muller

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Rachael Turner

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Mary J. Cunningham

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Site Public Contact

WCICTOresearch@urmc.rochester.edu

Principal Investigator:

Rachael Turner

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Angeles A. Secord

Duke Women's Cancer Care Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Site Public Contact

919-785-4878

Principal Investigator:

Angeles A. Secord

Essentia Health Cancer Center-South University Clinic

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

UHHS-Chagrin Highlands Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Amy Armstrong

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Michael S. Guy

Geauga Hospital

Recruiting

Chardon, Ohio, United States, 44024

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Amy Armstrong

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Amy Armstrong

Cleveland Clinic Cancer Center/Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Peter G. Rose

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Peter G. Rose

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Floor Backes

Hillcrest Hospital Cancer Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Peter G. Rose

UH Seidman Cancer Center at Lake Health Mentor Campus

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Amy Armstrong

University Hospitals Parma Medical Center

Recruiting

Parma, Ohio, United States, 44129

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Amy Armstrong

UH Seidman Cancer Center at Saint John Medical Center

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Amy Armstrong

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Christina Washington

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Dan S. Zuckerman

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Dan S. Zuckerman

UPMC-Heritage Valley Health System Beaver

Recruiting

Beaver, Pennsylvania, United States, 15009

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center at Butler Health System

Recruiting

Butler, Pennsylvania, United States, 16001

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center - Passavant - Cranberry

Recruiting

Cranberry Township, Pennsylvania, United States, 16066

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Alexander B. Olawaiye

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Alexander B. Olawaiye

IRMC Cancer Center

Recruiting

Indiana, Pennsylvania, United States, 15701

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Recruiting

Johnstown, Pennsylvania, United States, 15901

Contacts

Site Public Contact

814-534-4724

Principal Investigator:

Alexander B. Olawaiye

UPMC Cancer Center at UPMC McKeesport

Recruiting

McKeesport, Pennsylvania, United States, 15132

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center in Coraopolis

Recruiting

Moon Township, Pennsylvania, United States, 15108

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center - Part of Frick Hospital

Recruiting

Mount Pleasant, Pennsylvania, United States, 15666

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

Arnold Palmer Cancer Center Medical Oncology Norwin

Recruiting

N. Huntingdon, Pennsylvania, United States, 15642

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC Cancer Center-Natrona Heights

Recruiting

Natrona Heights, Pennsylvania, United States, 15065

Contacts

Site Public Contact

724-230-3030

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center - New Castle

Recruiting

New Castle, Pennsylvania, United States, 16105

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Alexander B. Olawaiye

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Public Contact

412-647-2811

Principal Investigator:

Alexander B. Olawaiye

UPMC-Saint Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Site Public Contact

412-784-4900

Principal Investigator:

Alexander B. Olawaiye

UPMC-Mercy Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Site Public Contact

800-533-8762

Principal Investigator:

Alexander B. Olawaiye

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Alexander B. Olawaiye

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Alexander B. Olawaiye

UPMC-Saint Clair Hospital Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

Site Public Contact

412-502-3920

Principal Investigator:

Alexander B. Olawaiye

UPMC Cancer Center at UPMC Northwest

Recruiting

Seneca, Pennsylvania, United States, 16346

Contacts

Site Public Contact

814-676-7900

Principal Investigator:

Alexander B. Olawaiye

UPMC Cancer Center-Washington

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Alexander B. Olawaiye

UPMC West Mifflin-Cancer Center Jefferson

Recruiting

West Mifflin, Pennsylvania, United States, 15122

Contacts

Site Public Contact

412-653-8100

Principal Investigator:

Alexander B. Olawaiye

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Site Public Contact

401-274-1122

Principal Investigator:

Cara A. Mathews

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Site Public Contact

214-590-5582canceranswerline@UTSouthwestern.edu

Principal Investigator:

David S. Miller

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

David S. Miller

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

David S. Miller

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Public Contact

972-669-7044Suzanne.cole@utsouthwestern.edu

Principal Investigator:

David S. Miller

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

434-243-6303uvacancertrials@hscmail.mcc.virginia.edu

Principal Investigator:

Linda R. Duska

Henrico Doctor's Hospital

Recruiting

Richmond, Virginia, United States, 23229

Contacts

Site Public Contact

804-591-4152

Principal Investigator:

Andrew S. Kennedy

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Northwest Wisconsin Cancer Center

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-04.