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NCT07195734RecruitingPhase 2

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
180 (estimated)
First submitted
26 Sept 2025
Start date
24 Apr 2026
Primary completion date
1 Feb 2033
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT07195734

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 180
  • From 24 Apr 2026 to the primary completion date, 1 Feb 2033
  • 115 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.

Who the study is looking for

  • Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx
  • PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
  • Verify insurance (or other payment) coverage for neoadjuvant chemotherapy
  • Measurable disease as defined by RECIST 1.1
  • Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery:
    • P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.
    • Patients must be deemed surgically resectable without gross residual disease.
    • For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.
    • Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.
    • Patients with resectable lymph node-only recurrence are eligible.
    • No major vascular involvement (\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection
  • No evidence of distant metastatic disease
  • The following minimum diagnostic workup is required:
    • General history and physical examination.
    • Diagnostic-quality neck CT and PET/CT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  • Platelets ≥ 100,000 cells/mm\^3
  • Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dL is acceptable)
  • Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
  • Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible.
    • Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent/recurrent cancer volume (\> 50%) irradiated to ≥ 40 Gy at the time
  • Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration
  • Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted
  • No investigational anti-cancer agents received within 4 weeks prior to registration
  • No New York Heart Association Functional Classification III or IV (Note: 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)
  • No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments
  • No peripheral neuropathy grade 3 or 4
  • No history of interstitial lung disease
  • No active, noninfectious pneumonitis requiring immunosuppressive therapy
  • No history of a solid organ transplant (other than corneal transplant)
  • No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids \[\> 10 mg prednisone/day or equivalent\] or immunosuppressive drugs)
    • NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
    • Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
    • Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
    • Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent are allowed. Inhaled or topical steroids are permitted
  • No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)

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

Full criteria on ClinicalTrials.gov

Sites (115)

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

SiteCityCountrySite status
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesRecruiting
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesRecruiting
Emory Proton Therapy Center
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AtlantaUnited StatesRecruiting
Emory University Hospital Midtown
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AtlantaUnited StatesRecruiting
LSU Health Baton Rouge-North Clinic
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Baton RougeUnited StatesRecruiting
Our Lady of The Lake
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Baton RougeUnited StatesRecruiting
Our Lady of the Lake Physician Group
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Baton RougeUnited StatesRecruiting
Lafayette Family Cancer Center-EMMC
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BrewerUnited StatesRecruiting
University of Michigan - Brighton Center for Specialty Care
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BrightonUnited StatesRecruiting
Cooper Hospital University Medical Center
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CamdenUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Rush MD Anderson Cancer Center
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ChicagoUnited StatesRecruiting
Siteman Cancer Center at Saint Peters Hospital
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City of Saint PetersUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesRecruiting
Atrium Health Cabarrus/LCI-Concord
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ConcordUnited StatesRecruiting
Methodist Jennie Edmundson Hospital
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Council BluffsUnited StatesSuspended
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
Broadlawns Medical Center
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Des MoinesUnited StatesRecruiting
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
Henry Ford Hospital
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DetroitUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Saint Vincent Hospital
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ErieUnited StatesRecruiting
UPMC Hillman Cancer Center Erie
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ErieUnited StatesRecruiting
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesRecruiting
UPMC Cancer Center at UPMC Horizon
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FarrellUnited 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
Legacy Mount Hood Medical Center
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GreshamUnited StatesRecruiting
IRMC Cancer Center
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IndianaUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
University of Mississippi Medical Center
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JacksonUnited StatesRecruiting
Jefferson Hospital
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Jefferson HillsUnited StatesRecruiting
Jersey City Medical Center
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Jersey CityUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Johnson Creek
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Johnson CreekUnited StatesRecruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center
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JohnstownUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - Briarcliff
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Kansas CityUnited StatesRecruiting
Gundersen Lutheran Medical Center
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La CrosseUnited StatesRecruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesRecruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
Rush MD Anderson Cancer Center at Rush Lisle
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LisleUnited StatesRecruiting
Cooperman Barnabas Medical Center
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LivingstonUnited StatesRecruiting
Monmouth Medical Center
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Long BranchUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Forbes Hospital
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MonroevilleUnited StatesRecruiting
UPMC Hillman Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
UPMC Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesRecruiting
Rutgers New Jersey Medical School
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NewarkUnited StatesRecruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesRecruiting
Northwestern Medicine Oak Brook
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Oak BrookUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
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OmahaUnited StatesRecruiting
Nebraska Methodist Hospital
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OmahaUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesRecruiting
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesRecruiting
UPMC-Shadyside Hospital
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PittsburghUnited StatesRecruiting
UPMC-Saint Clair Hospital Cancer Center
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PittsburghUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Allegheny General Hospital
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PittsburghUnited StatesRecruiting
UPMC-Saint Margaret
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PittsburghUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Legacy Good Samaritan Hospital and Medical Center
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PortlandUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Sutter Medical Center Sacramento
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SacramentoUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
UPMC Cancer Center at UPMC Northwest
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SenecaUnited StatesRecruiting
Memorial Hospital East
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ShilohUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesRecruiting
Siteman Cancer Center-South County
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St LouisUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
ProMedica Flower Hospital
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SylvaniaUnited StatesRecruiting
Community Medical Center
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Toms RiverUnited StatesRecruiting
Legacy Meridian Park Hospital
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TualatinUnited StatesRecruiting
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesRecruiting
Banner University Medical Center - Tucson
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TucsonUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Legacy Salmon Creek Hospital
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VancouverUnited StatesRecruiting
Legacy Cancer Institute Medical Oncology and Day Treatment
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VancouverUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
UPMC Cancer Center-Washington
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WashingtonUnited StatesRecruiting
UPMC Washington Hospital Radiation Oncology
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WashingtonUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
Wilmot Cancer Institute at Webster
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WebsterUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Wexford Health and Wellness Pavilion
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WexfordUnited StatesRecruiting
Asplundh Cancer Pavilion
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Willow GroveUnited StatesRecruiting

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