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NCT05647265RecruitingPhase 2

Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with 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 immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
26 (estimated)
First submitted
29 Nov 2022
Start date
27 Nov 2024
Primary completion date
15 Dec 2026
Lead sponsor
Alliance for Clinical Trials in Oncology
Diseases
Mesothelioma
NCT number
NCT05647265

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 26
  • From 27 Nov 2024 to the primary completion date, 15 Dec 2026
  • 132 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No patients deemed to be unresectable or poor surgical candidates

Other illness

  • No patients with a history of symptomatic interstitial lung disease

Other

  • No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes

Who the study is looking for

  • Sarcomatoid or sarcomatoid-dominant (\> 50%) biphasic, pleural mesothelioma
  • Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition
  • Measurable disease or non-measurable disease as defined
  • No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint
  • No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.)
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
    • \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
  • Age \>= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 or Karnofsky \>= 60%
  • Absolute neutrophil count (ANC) \>= 1,000/mm\^3
  • Leukocytes \>= 2,000/mm\^3
  • Platelet count \>= 100,000/mm\^3
  • Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \>= 40 mL/min
  • Total bilirubin =\<1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dl
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN
  • Alkaline (alk) phosphatase (phos) =\< 3.0 x ULN
  • No active, known or suspected autoimmune disease except for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody
  • No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • 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
  • 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
  • STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery
  • STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection
  • STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =\< 2 or Karnofsky \>= 60%
  • STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) \> 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) \> 35%
  • STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no more than 90 days after the last dose of neoadjuvant therapy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (132)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Providence Regional Cancer System-Aberdeen
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AberdeenUnited StatesRecruiting
Alaska Women's Cancer Care
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AnchorageUnited StatesRecruiting
Katmai Oncology Group
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AnchorageUnited StatesRecruiting
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesRecruiting
Anchorage Associates in Radiation Medicine
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AnchorageUnited StatesRecruiting
Anchorage Radiation Therapy Center
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AnchorageUnited StatesSuspended
Providence Alaska Medical Center
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AnchorageUnited StatesRecruiting
Alaska Breast Care and Surgery LLC
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AnchorageUnited StatesRecruiting
PCR Oncology
Coordinator of this site? Confirm its status
Arroyo GrandeUnited StatesRecruiting
Rush-Copley Medical Center
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AuroraUnited StatesRecruiting
Overlake Medical Center
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BellevueUnited StatesSuspended
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesRecruiting
Saint Charles Health System
Coordinator of this site? Confirm its status
BendUnited StatesRecruiting
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesRecruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesRecruiting
Carson Tahoe Regional Medical Center
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Carson CityUnited StatesRecruiting
Providence Regional Cancer System-Centralia
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CentraliaUnited StatesRecruiting
Christiana Care Health System-Concord Health Center
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Chadds FordUnited StatesActive, not recruiting
Northwestern University
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ChicagoUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
Providence Cancer Institute Clackamas Clinic
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ClackamasUnited StatesSuspended
Bay Area Hospital
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Coos BayUnited StatesRecruiting
UT Southwestern Simmons Cancer Center - RedBird
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DallasUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
Duke Cancer Center Southpoint
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DurhamUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Christiana Care - Union Hospital
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ElktonUnited StatesActive, not recruiting
Providence Regional Cancer Partnership
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EverettUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
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Fort WorthUnited StatesRecruiting
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
Northwestern Medicine Glenview Outpatient Center
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GlenviewUnited StatesRecruiting
Northwestern Medicine Grayslake Outpatient Center
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GrayslakeUnited StatesRecruiting
Oncology Las Vegas - Henderson
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HendersonUnited StatesRecruiting
Las Vegas Cancer Center-Henderson
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HendersonUnited StatesSuspended
Las Vegas Urology - Pebble
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HendersonUnited StatesSuspended
Urology Specialists of Nevada - Green Valley
Coordinator of this site? Confirm its status
HendersonUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
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HendersonUnited StatesRecruiting
Las Vegas Urology - Green Valley
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HendersonUnited StatesSuspended
Cancer and Blood Specialists-Henderson
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HendersonUnited StatesSuspended
Comprehensive Cancer Centers of Nevada - Henderson
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HendersonUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
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HendersonUnited StatesRecruiting
Providence Hood River Memorial Hospital
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Hood RiverUnited StatesRecruiting
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesRecruiting
Mayo Clinic in Florida
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JacksonvilleUnited StatesRecruiting
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesRecruiting
Kingman Regional Medical Center
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KingmanUnited StatesRecruiting
Providence Regional Cancer System-Lacey
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LaceyUnited StatesRecruiting
UC San Diego Moores Cancer Center
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La JollaUnited StatesRecruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada - Northwest
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Las VegasUnited StatesRecruiting
Hope Cancer Care of Nevada
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada-Summerlin
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Las VegasUnited StatesRecruiting
Radiation Oncology Centers of Nevada Central
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada - Central Valley
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Las VegasUnited StatesRecruiting
Las Vegas Urology - Cathedral Rock
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Las VegasUnited StatesSuspended
OptumCare Cancer Care at Charleston
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Las VegasUnited StatesRecruiting
OptumCare Cancer Care at Fort Apache
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Las VegasUnited StatesRecruiting
Sunrise Hospital and Medical Center
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Las VegasUnited StatesRecruiting
Urology Specialists of Nevada - Southwest
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Las VegasUnited StatesRecruiting
Oncology Las Vegas - Tenaya
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Las VegasUnited StatesRecruiting
Urology Specialists of Nevada - Central
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Las VegasUnited StatesRecruiting
Radiation Oncology Centers of Nevada Southeast
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesRecruiting
Summerlin Hospital Medical Center
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Las VegasUnited StatesRecruiting
Las Vegas Urology - Smoke Ranch
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Las VegasUnited StatesSuspended
Las Vegas Urology - Sunset
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Las VegasUnited StatesSuspended
Urology Specialists of Nevada - Northwest
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Las VegasUnited StatesRecruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las VegasUnited StatesRecruiting
Las Vegas Prostate Cancer Center
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Las VegasUnited StatesSuspended
University Cancer Center
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Las VegasUnited StatesSuspended
OptumCare Cancer Care at MountainView
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada - Town Center
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Las VegasUnited StatesRecruiting
Las Vegas Urology - Pecos
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Las VegasUnited StatesSuspended
Las Vegas Cancer Center-Medical Center
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Las VegasUnited StatesSuspended
Ann M Wierman MD LTD
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Las VegasUnited StatesSuspended
University Medical Center of Southern Nevada
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Las VegasUnited StatesRecruiting
Beebe Medical Center
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LewesUnited StatesActive, not recruiting
PeaceHealth Saint John Medical Center
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LongviewUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesRecruiting
Beebe South Coastal Health Campus
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MillvilleUnited StatesActive, not recruiting
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesRecruiting
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesRecruiting
Skagit Regional Health Cancer Care Center
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Mount VernonUnited StatesRecruiting
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesRecruiting
Providence Queen of The Valley
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NapaUnited StatesRecruiting
Delaware Clinical and Laboratory Physicians PA
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NewarkUnited StatesActive, not recruiting
Helen F Graham Cancer Center
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NewarkUnited StatesActive, not recruiting
Christiana Care Health System-Christiana Hospital
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NewarkUnited StatesActive, not recruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesActive, not recruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
Hope Cancer Care of Nevada-Pahrump
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PahrumpUnited StatesRecruiting
Mayo Clinic Hospital in Arizona
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PhoenixUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Duke Cancer Center Raleigh
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RaleighUnited StatesRecruiting
Saint Charles Health System-Redmond
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RedmondUnited StatesRecruiting
Beebe Health Campus
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Rehoboth BeachUnited StatesActive, not recruiting
Saint Mary's Regional Medical Center
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RenoUnited StatesRecruiting
Renown Regional Medical Center
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RenoUnited StatesRecruiting
Radiation Oncology Associates
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RenoUnited StatesSuspended
Valley Medical Center
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RentonUnited StatesRecruiting
UT Southwestern Clinical Center at Richardson/Plano
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RichardsonUnited StatesRecruiting
Mayo Clinic in Rochester
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RochesterUnited StatesRecruiting
Providence Medical Foundation - Santa Rosa
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Santa RosaUnited StatesRecruiting
Providence Santa Rosa Memorial Hospital
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Santa RosaUnited StatesRecruiting
Mayo Clinic in Arizona
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ScottsdaleUnited StatesRecruiting
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesRecruiting
Swedish Medical Center-Cherry Hill
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SeattleUnited StatesRecruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesRecruiting
Providence Regional Cancer System-Shelton
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SheltonUnited StatesSuspended
Cancer Care Northwest - Spokane South
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SpokaneUnited StatesRecruiting
Cancer Care Northwest-Valley
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SpokaneUnited StatesRecruiting
Cancer Care Northwest-North Spokane
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SpokaneUnited StatesRecruiting
Saint Luke's Cancer Institute - Twin Falls
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Twin FallsUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
PeaceHealth Southwest Medical Center
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VancouverUnited StatesRecruiting
Providence Saint Mary Regional Cancer Center
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Walla WallaUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
Christiana Care Health System-Wilmington Hospital
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WilmingtonUnited StatesActive, not recruiting
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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YakimaUnited StatesRecruiting
Providence Regional Cancer System-Yelm
Coordinator of this site? Confirm its status
YelmUnited StatesSuspended
Rush-Copley Healthcare Center
Coordinator of this site? Confirm its status
YorkvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.