Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

Trial Title: Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

NCT ID: NCT05694871

Condition: Advanced Dedifferentiated Liposarcoma
Locally Advanced Dedifferentiated Liposarcoma
Metastatic Dedifferentiated Liposarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Unresectable Dedifferentiated Liposarcoma

Conditions: Official terms:
Sarcoma
Liposarcoma
Palbociclib
Cemiplimab
Immunoglobulins
Immunoglobulin G

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Palbociclib
Description: Given PO
Arm group label: Arm I (palbociclib)
Arm group label: Arm II (palbociclib, cemiplimab)

Other name: PD-0332991

Intervention type: Biological
Intervention name: Cemiplimab
Description: Given IV
Arm group label: Arm II (palbociclib, cemiplimab)

Other name: Cemiplimab RWLC

Other name: Immunoglobulin G4

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: undergo MRI
Arm group label: Arm I (palbociclib)
Arm group label: Arm II (palbociclib, cemiplimab)

Other name: MRI

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo a CT Scan
Arm group label: Arm I (palbociclib)
Arm group label: Arm II (palbociclib, cemiplimab)

Other name: CAT Scan

Other name: CT Scan

Intervention type: Procedure
Intervention name: Biospecimen collection
Description: Undergo blood sample collection
Arm group label: Arm I (palbociclib)
Arm group label: Arm II (palbociclib, cemiplimab)

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary Studies
Arm group label: Arm I (palbociclib)
Arm group label: Arm II (palbociclib, cemiplimab)

Summary: This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone.

Detailed description: PRIMARY OBJECTIVES: I. To perform a safety lead-in among 6 patients to confirm that the combination of palbociclib and cemiplimab is safe and tolerable. II. To evaluate whether palbociclib in combination with cemiplimab (Arm 2) demonstrates a superior progression-free survival (PFS) compared to palbociclib monotherapy (Arm 1) for patients with advanced dedifferentiated liposarcoma (DDLPS). SECONDARY OBJECTIVES: I. To evaluate the toxicity profile in and across each treatment arm as determined by both Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO)-CTCAE criteria. II. To evaluate and compare the objective response rate (ORR) and duration of response (DOR) in and across each treatment arm. III. To evaluate and compare the overall survival (OS) in and across each treatment arm. IV. To evaluate and compare progression-free rate at 8 weeks (PFR8) in and across each treatment arm. EXPLORATORY OBJECTIVES: I. To collect genomic sequencing data previously collected as standard of care, including data on CDK4 copy number (as determined by fluorescence in situ hybridization [FISH] or other molecular testing). II. To conduct multiplex immunohistochemistry using archival tumor tissue (where available) to define densities of infiltrating immune cell subsets and tumor and immune cell major histocompatibility complex (MHC) and PD-L1 expression. III. To perform an exploratory analysis to evaluate for any relationship between CDK4 copy number and (a) the tumor immune microenvironment as defined by multiplex immunohistochemistry and (b) clinical outcomes from study treatment. IV. To explore efficacy and toxicity endpoints, including PFS and ORR, for patients who progress on palbociclib monotherapy and crossover to the palbociclib plus cemiplimab combination. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive palbociclib orally (PO) on study. Patients will be allowed to cross over to Arm II following documentation of disease progression. Patients undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans throughout the trial. Patients may also undergo blood sample collection on study. ARM II: Patients receive palbociclib PO and cemiplimab intravenously (IV) on study. Patients undergo MRI or CT scans throughout the trial. Patients may also undergo blood sample collection on study.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - ELIGIBILITY CRITERIA (STEP 1): Patients must have histologically documented dedifferentiated liposarcoma (DDLPS). Patients with mixed well-differentiated/dedifferentiated liposarcoma (WD/DD LPS) tumors are eligible provided there is a histologically confirmed DDLPS component at some point during the treatment course - Disease must be metastatic or locally advanced and surgically unresectable, in the opinion of the treating investigator - Note: Intact retinoblastoma protein (RB) can be assumed in DDLPS. In a query of project Genomics Evidence Neoplasia Information Exchange (GENIE) (American Association for Cancer Research [AACR]), including 286 DDLPS tumors, the rate of RB1 mutation in DDLPS was 1.37%. Therefore, molecular testing to determine intact Rb is not required - ELIGIBILITY CRITERIA (STEP 1): Patients must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria to be eligible for this study. Previously radiated lesions should not be used as target lesions unless there is documented evidence of disease progression of that lesion after radiation - ELIGIBILITY CRITERIA (STEP 1): Patients may have received any number of prior systemic treatment lines for DDLPS, including none - ELIGIBILITY CRITERIA (STEP 1): Patients must have recovered to baseline or =< grade 1 per CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy, and with the exceptions of fatigue (which must be =< grade 2), alopecia and/or endocrinopathies related to prior immunotherapy which are controlled with hormone replacement - ELIGIBILITY CRITERIA (STEP 1): Patients must have completed all prior anti-cancer treatment, including radiation, >= 14 days prior to registration - ELIGIBILITY CRITERIA (STEP 1): Age >= 18 years - ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - ELIGIBILITY CRITERIA (STEP 1): Absolute neutrophil count (ANC) >= 1000/mm^3 - ELIGIBILITY CRITERIA (STEP 1): Platelet count >= 100,000/mm^3 - ELIGIBILITY CRITERIA (STEP 1): Hemoglobin >= 9 g/dL - ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance (CrCl) >= 30 mL/min - ELIGIBILITY CRITERIA (STEP 1): Total bilirubin =< 1.5 x upper limit of normal (ULN) - ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN - ELIGIBILITY CRITERIA (STEP 1): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible, patients should be class IIB or better. Furthermore, patients may not have an uncontrolled ventricular arrhythmia or recent (within 3 months) myocardial infarction - ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently receiving treatment, they are eligible if they have an undetectable HCV viral load - ELIGIBILITY CRITERIA (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial - ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients participating on this trial may not be receiving other anti-neoplastic therapies and there should be no anticipated need for such therapy - ELIGIBILITY CRITERIA (STEP 1): Patients with treated brain metastases that are non-progressing are eligible if follow-up brain imaging performed at least 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are not eligible - ELIGIBILITY CRITERIA (STEP 1): Patients must be able to swallow oral medications - RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): In order to cross over to Arm 2, patients must meet the same eligibility criteria as described above - RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Patients must have demonstrated progression of disease on palbociclib monotherapy (Arm 1) per RECIST version 1.1 criteria Exclusion Criteria: - ELIGIBILITY CRITERIA (STEP 1): Patients may not have received prior treatment with CDK4/6 inhibitors (including, but not limited to: palbociclib, ribociclib or abemaciclib) or anti-PD-1/anti-PD-L1 antibodies - ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required - ELIGIBILITY CRITERIA (STEP 1): Patients must not have an active autoimmune disease with the exception of vitiligo, well-controlled asthma or allergic rhinitis, type 1 diabetes, psoriasis or hypothyroidism. Patients with a history of adrenal insufficiency are eligible if on a stable dose of prednisone =< 10 mg or equivalent - ELIGIBILITY CRITERIA (STEP 1): Patients must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any other condition that would limit compliance with study requirements - ELIGIBILITY CRITERIA (STEP 1): Patients may not require the use of chronic steroids in excess of 10 mg prednisone daily or equivalent - ELIGIBILITY CRITERIA (STEP 1): Patients may not require concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir). The required washout period prior to re-registration 2 weeks - ELIGIBILITY CRITERIA (STEP 1): Patients may not require concomitant use of known strong CYP3A inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort). The required washout period prior to re-registration is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents - RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Patients may not have experienced a grade 3 or higher non-hematologic adverse event deemed clinically significant in the opinion of the treating investigator, or have discontinued palbociclib due to toxicity, while participating on Arm 1 - Patients must also have recovered to baseline or =< grade 1 per CTCAE version 5.0 from toxicity related to Arm 1 treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy, and with the exceptions of fatigue (which must be =< grade 2), alopecia and/or endocrinopathies related to prior immunotherapy which are controlled with hormone replacement - Note: Patients who underwent dose reduction of palbociclib during treatment on Arm 1 will begin treatment on Arm 2 at the same dose (i.e. dose re-escalation is not allowed) - RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Patients may not have received prior treatment with anti-PD-1/anti-PD-L1 antibodies - RE-REGISTRATION ELIGIBILITY CRITERIA (FOR STEP 2 CROSSOVER FROM ARM 1 TO ARM 2): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to re-registration is required

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham Cancer Center

Address:
City: Birmingham
Zip: 35233
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Facility:
Name: Cancer Center at Saint Joseph's

Address:
City: Phoenix
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Facility:
Name: Mayo Clinic Hospital in Arizona

Address:
City: Phoenix
Zip: 85054
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Facility:
Name: Mayo Clinic in Arizona

Address:
City: Scottsdale
Zip: 85259
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Facility:
Name: Kaiser Permanente-Deer Valley Medical Center

Address:
City: Antioch
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Facility:
Name: Mission Hope Medical Oncology - Arroyo Grande

Address:
City: Arroyo Grande
Zip: 93420
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Facility:
Name: Mercy Cancer Center - Carmichael

Address:
City: Carmichael
Zip: 95608
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Facility:
Name: Mercy San Juan Medical Center

Address:
City: Carmichael
Zip: 95608
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Facility:
Name: City of Hope Comprehensive Cancer Center

Address:
City: Duarte
Zip: 91010
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Facility:
Name: Kaiser Permanente Dublin

Address:
City: Dublin
Zip: 94568
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Facility:
Name: Mercy Cancer Center - Elk Grove

Address:
City: Elk Grove
Zip: 95758
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Facility:
Name: Kaiser Permanente-Fremont

Address:
City: Fremont
Zip: 94538
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Facility:
Name: Fresno Cancer Center

Address:
City: Fresno
Zip: 93720
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Facility:
Name: Kaiser Permanente-Fresno

Address:
City: Fresno
Zip: 93720
Country: United States

Facility:
Name: Mercy Cancer Center

Address:
City: Merced
Zip: 95340
Country: United States

Facility:
Name: Kaiser Permanente-Modesto

Address:
City: Modesto
Zip: 95356
Country: United States

Facility:
Name: Kaiser Permanente Oakland-Broadway

Address:
City: Oakland
Zip: 94611
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Facility:
Name: Kaiser Permanente-Oakland

Address:
City: Oakland
Zip: 94611
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Facility:
Name: Kaiser Permanente-Rancho Cordova Cancer Center

Address:
City: Rancho Cordova
Zip: 95670
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Facility:
Name: Kaiser Permanente- Marshall Medical Offices

Address:
City: Redwood City
Zip: 94063
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Facility:
Name: Kaiser Permanente-Richmond

Address:
City: Richmond
Zip: 94801
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Facility:
Name: Mercy Cancer Center - Rocklin

Address:
City: Rocklin
Zip: 95765
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Facility:
Name: Rohnert Park Cancer Center

Address:
City: Rohnert Park
Zip: 94928
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Facility:
Name: Kaiser Permanente-Roseville

Address:
City: Roseville
Zip: 95661
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Facility:
Name: The Permanente Medical Group-Roseville Radiation Oncology

Address:
City: Roseville
Zip: 95678
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Facility:
Name: Kaiser Permanente Downtown Commons

Address:
City: Sacramento
Zip: 95814
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Facility:
Name: Mercy Cancer Center - Sacramento

Address:
City: Sacramento
Zip: 95816
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Facility:
Name: South Sacramento Cancer Center

Address:
City: Sacramento
Zip: 95823
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Facility:
Name: Kaiser Permanente-San Francisco

Address:
City: San Francisco
Zip: 94115
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Facility:
Name: Kaiser Permanente-Santa Teresa-San Jose

Address:
City: San Jose
Zip: 95119
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Facility:
Name: Kaiser Permanente San Leandro

Address:
City: San Leandro
Zip: 94577
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Facility:
Name: Pacific Central Coast Health Center-San Luis Obispo

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City: San Luis Obispo
Zip: 93401
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Facility:
Name: Kaiser San Rafael-Gallinas

Address:
City: San Rafael
Zip: 94903
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Facility:
Name: Kaiser Permanente Medical Center - Santa Clara

Address:
City: Santa Clara
Zip: 95051
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Facility:
Name: Mission Hope Medical Oncology - Santa Maria

Address:
City: Santa Maria
Zip: 93444
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Facility:
Name: Kaiser Permanente-Santa Rosa

Address:
City: Santa Rosa
Zip: 95403
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Facility:
Name: Kaiser Permanente Cancer Treatment Center

Address:
City: South San Francisco
Zip: 94080
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Facility:
Name: Kaiser Permanente-South San Francisco

Address:
City: South San Francisco
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Facility:
Name: Kaiser Permanente-Stockton

Address:
City: Stockton
Zip: 95210
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Facility:
Name: Kaiser Permanente Medical Center-Vacaville

Address:
City: Vacaville
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Facility:
Name: Kaiser Permanente-Vallejo

Address:
City: Vallejo
Zip: 94589
Country: United States

Facility:
Name: Kaiser Permanente-Walnut Creek

Address:
City: Walnut Creek
Zip: 94596
Country: United States

Facility:
Name: Woodland Memorial Hospital

Address:
City: Woodland
Zip: 95695
Country: United States

Facility:
Name: Penrose-Saint Francis Healthcare

Address:
City: Colorado Springs
Zip: 80907
Country: United States

Facility:
Name: Rocky Mountain Cancer Centers-Penrose

Address:
City: Colorado Springs
Zip: 80907
Country: United States

Facility:
Name: Saint Francis Cancer Center

Address:
City: Colorado Springs
Zip: 80923
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Facility:
Name: Porter Adventist Hospital

Address:
City: Denver
Zip: 80210
Country: United States

Facility:
Name: Mercy Medical Center

Address:
City: Durango
Zip: 81301
Country: United States

Facility:
Name: Southwest Oncology PC

Address:
City: Durango
Zip: 81301
Country: United States

Facility:
Name: Saint Anthony Hospital

Address:
City: Lakewood
Zip: 80228
Country: United States

Facility:
Name: Littleton Adventist Hospital

Address:
City: Littleton
Zip: 80122
Country: United States

Facility:
Name: Longmont United Hospital

Address:
City: Longmont
Zip: 80501
Country: United States

Facility:
Name: Parker Adventist Hospital

Address:
City: Parker
Zip: 80138
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Facility:
Name: Saint Mary Corwin Medical Center

Address:
City: Pueblo
Zip: 81004
Country: United States

Facility:
Name: MedStar Washington Hospital Center

Address:
City: Washington
Zip: 20010
Country: United States

Facility:
Name: Mayo Clinic in Florida

Address:
City: Jacksonville
Zip: 32224-9980
Country: United States

Facility:
Name: Kaiser Permanente Moanalua Medical Center

Address:
City: Honolulu
Zip: 96819
Country: United States

Facility:
Name: Rush - Copley Medical Center

Address:
City: Aurora
Zip: 60504
Country: United States

Facility:
Name: Illinois CancerCare-Bloomington

Address:
City: Bloomington
Zip: 61704
Country: United States

Facility:
Name: Illinois CancerCare-Canton

Address:
City: Canton
Zip: 61520
Country: United States

Facility:
Name: Memorial Hospital of Carbondale

Address:
City: Carbondale
Zip: 62902
Country: United States

Facility:
Name: SIH Cancer Institute

Address:
City: Carterville
Zip: 62918
Country: United States

Facility:
Name: Illinois CancerCare-Carthage

Address:
City: Carthage
Zip: 62321
Country: United States

Facility:
Name: Centralia Oncology Clinic

Address:
City: Centralia
Zip: 62801
Country: United States

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Facility:
Name: Carle at The Riverfront

Address:
City: Danville
Zip: 61832
Country: United States

Facility:
Name: Cancer Care Specialists of Illinois - Decatur

Address:
City: Decatur
Zip: 62526
Country: United States

Facility:
Name: Decatur Memorial Hospital

Address:
City: Decatur
Zip: 62526
Country: United States

Facility:
Name: Northwestern Medicine Cancer Center Kishwaukee

Address:
City: DeKalb
Zip: 60115
Country: United States

Facility:
Name: Illinois CancerCare-Dixon

Address:
City: Dixon
Zip: 61021
Country: United States

Facility:
Name: Carle Physician Group-Effingham

Address:
City: Effingham
Zip: 62401
Country: United States

Facility:
Name: Crossroads Cancer Center

Address:
City: Effingham
Zip: 62401
Country: United States

Facility:
Name: Illinois CancerCare-Eureka

Address:
City: Eureka
Zip: 61530
Country: United States

Facility:
Name: NorthShore University HealthSystem-Evanston Hospital

Address:
City: Evanston
Zip: 60201
Country: United States

Facility:
Name: Illinois CancerCare-Galesburg

Address:
City: Galesburg
Zip: 61401
Country: United States

Facility:
Name: Western Illinois Cancer Treatment Center

Address:
City: Galesburg
Zip: 61401
Country: United States

Facility:
Name: Northwestern Medicine Cancer Center Delnor

Address:
City: Geneva
Zip: 60134
Country: United States

Facility:
Name: NorthShore University HealthSystem-Glenbrook Hospital

Address:
City: Glenview
Zip: 60026
Country: United States

Facility:
Name: Northwestern Medicine Glenview Outpatient Center

Address:
City: Glenview
Zip: 60026
Country: United States

Facility:
Name: Northwestern Medicine Grayslake Outpatient Center

Address:
City: Grayslake
Zip: 60030
Country: United States

Facility:
Name: NorthShore University HealthSystem-Highland Park Hospital

Address:
City: Highland Park
Zip: 60035
Country: United States

Facility:
Name: Illinois CancerCare-Kewanee Clinic

Address:
City: Kewanee
Zip: 61443
Country: United States

Facility:
Name: Northwestern Medicine Lake Forest Hospital

Address:
City: Lake Forest
Zip: 60045
Country: United States

Facility:
Name: Illinois CancerCare-Macomb

Address:
City: Macomb
Zip: 61455
Country: United States

Facility:
Name: Carle Physician Group-Mattoon/Charleston

Address:
City: Mattoon
Zip: 61938
Country: United States

Facility:
Name: Cancer Care Center of O'Fallon

Address:
City: O'Fallon
Zip: 62269
Country: United States

Facility:
Name: HSHS Saint Elizabeth's Hospital

Address:
City: O'Fallon
Zip: 62269
Country: United States

Facility:
Name: Northwestern Medicine Orland Park

Address:
City: Orland Park
Zip: 60462
Country: United States

Facility:
Name: Illinois CancerCare-Ottawa Clinic

Address:
City: Ottawa
Zip: 61350
Country: United States

Facility:
Name: Illinois CancerCare-Pekin

Address:
City: Pekin
Zip: 61554
Country: United States

Facility:
Name: Illinois CancerCare-Peoria

Address:
City: Peoria
Zip: 61615
Country: United States

Facility:
Name: Methodist Medical Center of Illinois

Address:
City: Peoria
Zip: 61636
Country: United States

Facility:
Name: Illinois CancerCare-Peru

Address:
City: Peru
Zip: 61354
Country: United States

Facility:
Name: Valley Radiation Oncology

Address:
City: Peru
Zip: 61354
Country: United States

Facility:
Name: Illinois CancerCare-Princeton

Address:
City: Princeton
Zip: 61356
Country: United States

Facility:
Name: Southern Illinois University School of Medicine

Address:
City: Springfield
Zip: 62702
Country: United States

Facility:
Name: Springfield Clinic

Address:
City: Springfield
Zip: 62702
Country: United States

Facility:
Name: Memorial Medical Center

Address:
City: Springfield
Zip: 62781
Country: United States

Facility:
Name: Carle Cancer Center

Address:
City: Urbana
Zip: 61801
Country: United States

Facility:
Name: Northwestern Medicine Cancer Center Warrenville

Address:
City: Warrenville
Zip: 60555
Country: United States

Facility:
Name: Illinois CancerCare - Washington

Address:
City: Washington
Zip: 61571
Country: United States

Facility:
Name: Northwestern Medicine Central DuPage Hospital

Address:
City: Winfield
Zip: 60190
Country: United States

Facility:
Name: Rush-Copley Healthcare Center

Address:
City: Yorkville
Zip: 60560
Country: United States

Facility:
Name: Alegent Health Mercy Hospital

Address:
City: Council Bluffs
Zip: 51503
Country: United States

Facility:
Name: Heartland Oncology and Hematology LLP

Address:
City: Council Bluffs
Zip: 51503
Country: United States

Facility:
Name: Methodist Jennie Edmundson Hospital

Address:
City: Council Bluffs
Zip: 51503
Country: United States

Facility:
Name: Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Address:
City: Council Bluffs
Zip: 51503
Country: United States

Facility:
Name: Flaget Memorial Hospital

Address:
City: Bardstown
Zip: 40004
Country: United States

Facility:
Name: Commonwealth Cancer Center-Corbin

Address:
City: Corbin
Zip: 40701
Country: United States

Facility:
Name: Saint Joseph Hospital

Address:
City: Lexington
Zip: 40504
Country: United States

Facility:
Name: Saint Joseph Radiation Oncology Resource Center

Address:
City: Lexington
Zip: 40504
Country: United States

Facility:
Name: Saint Joseph Hospital East

Address:
City: Lexington
Zip: 40509
Country: United States

Facility:
Name: Saint Joseph London

Address:
City: London
Zip: 40741
Country: United States

Facility:
Name: Saint Joseph Mount Sterling

Address:
City: Mount Sterling
Zip: 40353
Country: United States

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Henry Ford Cancer Institute-Downriver

Address:
City: Brownstown
Zip: 48183
Country: United States

Facility:
Name: Henry Ford Macomb Hospital-Clinton Township

Address:
City: Clinton Township
Zip: 48038
Country: United States

Facility:
Name: Henry Ford Medical Center-Fairlane

Address:
City: Dearborn
Zip: 48126
Country: United States

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Henry Ford Medical Center-Columbus

Address:
City: Novi
Zip: 48377
Country: United States

Facility:
Name: Henry Ford West Bloomfield Hospital

Address:
City: West Bloomfield
Zip: 48322
Country: United States

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Facility:
Name: Saint Francis Medical Center

Address:
City: Cape Girardeau
Zip: 63703
Country: United States

Facility:
Name: Southeast Cancer Center

Address:
City: Cape Girardeau
Zip: 63703
Country: United States

Facility:
Name: Parkland Health Center - Farmington

Address:
City: Farmington
Zip: 63640
Country: United States

Facility:
Name: MU Health Care Goldschmidt Cancer Center

Address:
City: Jefferson City
Zip: 65109
Country: United States

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: Siteman Cancer Center-South County

Address:
City: Saint Louis
Zip: 63129
Country: United States

Facility:
Name: Missouri Baptist Medical Center

Address:
City: Saint Louis
Zip: 63131
Country: United States

Facility:
Name: Sainte Genevieve County Memorial Hospital

Address:
City: Sainte Genevieve
Zip: 63670
Country: United States

Facility:
Name: Missouri Baptist Sullivan Hospital

Address:
City: Sullivan
Zip: 63080
Country: United States

Facility:
Name: BJC Outpatient Center at Sunset Hills

Address:
City: Sunset Hills
Zip: 63127
Country: United States

Facility:
Name: Nebraska Medicine-Bellevue

Address:
City: Bellevue
Zip: 68123
Country: United States

Facility:
Name: CHI Health Good Samaritan

Address:
City: Kearney
Zip: 68847
Country: United States

Facility:
Name: Saint Elizabeth Regional Medical Center

Address:
City: Lincoln
Zip: 68510
Country: United States

Facility:
Name: Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Address:
City: Omaha
Zip: 68114
Country: United States

Facility:
Name: Nebraska Methodist Hospital

Address:
City: Omaha
Zip: 68114
Country: United States

Facility:
Name: Oncology Associates PC

Address:
City: Omaha
Zip: 68114
Country: United States

Facility:
Name: Nebraska Medicine-Village Pointe

Address:
City: Omaha
Zip: 68118
Country: United States

Facility:
Name: Alegent Health Immanuel Medical Center

Address:
City: Omaha
Zip: 68122
Country: United States

Facility:
Name: Alegent Health Bergan Mercy Medical Center

Address:
City: Omaha
Zip: 68124
Country: United States

Facility:
Name: Alegent Health Lakeside Hospital

Address:
City: Omaha
Zip: 68130
Country: United States

Facility:
Name: Creighton University Medical Center

Address:
City: Omaha
Zip: 68131
Country: United States

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Facility:
Name: Midlands Community Hospital

Address:
City: Papillion
Zip: 68046
Country: United States

Facility:
Name: Hunterdon Medical Center

Address:
City: Flemington
Zip: 08822
Country: United States

Facility:
Name: Hackensack University Medical Center

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: Jersey Shore Medical Center

Address:
City: Neptune
Zip: 07753
Country: United States

Facility:
Name: Roswell Park Cancer Institute

Address:
City: Buffalo
Zip: 14263
Country: United States

Facility:
Name: Carolinas Medical Center/Levine Cancer Institute

Address:
City: Charlotte
Zip: 28203
Country: United States

Facility:
Name: Atrium Health Pineville/LCI-Pineville

Address:
City: Charlotte
Zip: 28210
Country: United States

Facility:
Name: UH Seidman Cancer Center at UH Avon Health Center

Address:
City: Avon
Zip: 44011
Country: United States

Facility:
Name: UHHS-Chagrin Highlands Medical Center

Address:
City: Beachwood
Zip: 44122
Country: United States

Facility:
Name: Geauga Hospital

Address:
City: Chardon
Zip: 44024
Country: United States

Facility:
Name: Good Samaritan Hospital - Cincinnati

Address:
City: Cincinnati
Zip: 45220
Country: United States

Facility:
Name: Bethesda North Hospital

Address:
City: Cincinnati
Zip: 45242
Country: United States

Facility:
Name: TriHealth Cancer Institute-Westside

Address:
City: Cincinnati
Zip: 45247
Country: United States

Facility:
Name: TriHealth Cancer Institute-Anderson

Address:
City: Cincinnati
Zip: 45255
Country: United States

Facility:
Name: Case Western Reserve University

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: Cleveland Clinic Foundation

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Facility:
Name: University Hospitals Parma Medical Center

Address:
City: Parma
Zip: 44129
Country: United States

Facility:
Name: UH Seidman Cancer Center at Firelands Regional Medical Center

Address:
City: Sandusky
Zip: 44870
Country: United States

Facility:
Name: UH Seidman Cancer Center at Saint John Medical Center

Address:
City: Westlake
Zip: 44145
Country: United States

Facility:
Name: University of Oklahoma Health Sciences Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Facility:
Name: Oregon Health and Science University

Address:
City: Portland
Zip: 97239
Country: United States

Facility:
Name: M D Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Huntsman Cancer Institute/University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Facility:
Name: Virginia Cancer Institute

Address:
City: Richmond
Zip: 23229
Country: United States

Facility:
Name: VCU Massey Cancer Center at Stony Point

Address:
City: Richmond
Zip: 23235
Country: United States

Facility:
Name: Virginia Commonwealth University/Massey Cancer Center

Address:
City: Richmond
Zip: 23298
Country: United States

Facility:
Name: Fred Hutchinson Cancer Center

Address:
City: Seattle
Zip: 98109
Country: United States

Facility:
Name: University of Washington Medical Center - Montlake

Address:
City: Seattle
Zip: 98195
Country: United States

Facility:
Name: Saint Michael Cancer Center

Address:
City: Silverdale
Zip: 98383
Country: United States

Facility:
Name: West Virginia University Charleston Division

Address:
City: Charleston
Zip: 25304
Country: United States

Facility:
Name: ThedaCare Regional Cancer Center

Address:
City: Appleton
Zip: 54911
Country: United States

Facility:
Name: Marshfield Clinic-Chippewa Center

Address:
City: Chippewa Falls
Zip: 54729
Country: United States

Facility:
Name: Marshfield Medical Center-EC Cancer Center

Address:
City: Eau Claire
Zip: 54701
Country: United States

Facility:
Name: Mercyhealth Hospital and Cancer Center - Janesville

Address:
City: Janesville
Zip: 53548
Country: United States

Facility:
Name: Marshfield Medical Center - Ladysmith

Address:
City: Ladysmith
Zip: 54848
Country: United States

Facility:
Name: Marshfield Medical Center-Marshfield

Address:
City: Marshfield
Zip: 54449
Country: United States

Facility:
Name: Medical College of Wisconsin

Address:
City: Milwaukee
Zip: 53226
Country: United States

Facility:
Name: Marshfield Clinic-Minocqua Center

Address:
City: Minocqua
Zip: 54548
Country: United States

Facility:
Name: ProHealth D N Greenwald Center

Address:
City: Mukwonago
Zip: 53149
Country: United States

Facility:
Name: Marshfield Medical Center - Neillsville

Address:
City: Neillsville
Zip: 54456
Country: United States

Facility:
Name: ProHealth Oconomowoc Memorial Hospital

Address:
City: Oconomowoc
Zip: 53066
Country: United States

Facility:
Name: Marshfield Medical Center-Rice Lake

Address:
City: Rice Lake
Zip: 54868
Country: United States

Facility:
Name: Marshfield Medical Center-River Region at Stevens Point

Address:
City: Stevens Point
Zip: 54482
Country: United States

Facility:
Name: ProHealth Waukesha Memorial Hospital

Address:
City: Waukesha
Zip: 53188
Country: United States

Facility:
Name: UW Cancer Center at ProHealth Care

Address:
City: Waukesha
Zip: 53188
Country: United States

Facility:
Name: ThedaCare Cancer Care - Waupaca

Address:
City: Waupaca
Zip: 54981
Country: United States

Facility:
Name: Marshfield Clinic-Wausau Center

Address:
City: Wausau
Zip: 54401
Country: United States

Facility:
Name: Marshfield Medical Center - Weston

Address:
City: Weston
Zip: 54476
Country: United States

Facility:
Name: Marshfield Clinic - Wisconsin Rapids Center

Address:
City: Wisconsin Rapids
Zip: 54494
Country: United States

Start date: May 30, 2023

Completion date: May 31, 2027

Lead sponsor:
Agency: Alliance for Clinical Trials in Oncology
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Alliance for Clinical Trials in Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05694871