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NCT07768189RecruitingPhase 3

A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma

A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are: * What proportion of participants respond to CRB-701 measured using scans (CT or MRI) * What medical problems do participants experience when taking CRB-701. Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease). Participants will: * Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving. * Have a CT or MRI every 6 weeks to measure the effect on their cancer * Complete questionnaires to assess their health status.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
260 (estimated)
First submitted
12 Aug 2026
Start date
29 Sept 2026
Primary completion date
Dec 2027
Lead sponsor
Corbus Pharmaceuticals Inc.
NCT number
NCT07768189
EU CT number
2026-527123-94-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 260
  • From 29 Sept 2026 to the primary completion date, Dec 2027
  • 110 sites in 14 countries
  • 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

  • Persistent CTCAE Grade \>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.

Other illness

  • Significant active or chronic corneal disorders

Lab values

  • Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results.

Other

  • Pre-existing Grade ≥2 peripheral neuropathy
  • Pregnant or breastfeeding females

Who the study is looking for

  • Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent.
  • Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.
  • ECOG PS of 0-1
  • Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation.
  • Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment.
    • Signed informed consent

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

Full criteria on ClinicalTrials.gov

Sites (110)

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

SiteCityCountrySite status
Ordensklinikum Linz Barmherzige Schwestern
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LinzAustriaNot yet recruiting
University Hospital Vienna
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ViennaAustriaNot yet recruiting
Universitair Ziekenhuis Antwerpen (Uza)
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EdegemBelgiumNot yet recruiting
UZ Gent
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GhentBelgiumNot yet recruiting
UZ Leuven - Gasthuisberg Campus
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LeuvenBelgiumNot yet recruiting
Vitaz - Sint-Niklaas Moerland
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Sint-NiklaasBelgiumNot yet recruiting
Cliniques Universitaires Saint-Luc - Centre du Cancer
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Woluwe-Saint-LambertBelgiumNot yet recruiting
Cross Cancer Institute
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EdmontonCanadaNot yet recruiting
Verspeeten Family Cancer Centre
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LondonCanadaNot yet recruiting
Jewish General Hospital
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MontrealCanadaNot yet recruiting
The Ottawa Hospital Cancer Centre
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OttawaCanadaNot yet recruiting
Allan Blair Cancer Centre
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ReginaCanadaNot yet recruiting
Universitätsklinikum Köln - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
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CologneGermanyNot yet recruiting
Universitaetsklinikum Leipzig
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LeipzigGermanyNot yet recruiting
Universitaetsklinikum Muenster (UKM) - Klinik fuer Hals, Nasen und Ohrenheilkunde
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MünsterGermanyNot yet recruiting
Vall d'Hebron Institute of Oncology (VHIO)
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BarcelonaSpainNot yet recruiting
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals,
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BarcelonaSpainNot yet recruiting
Hospital Clinic Barcelona
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BarcelonaSpainNot yet recruiting
Institut Catala D'Oncologia Girona - Hospital Josep Trueta
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GironaSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainNot yet recruiting
Hospital Universitario Virgen Del Rocio (Huvr)
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SevilleSpainNot yet recruiting
Hospital Universitario la Fe
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ValenciaSpainNot yet recruiting
Hospital Universitario Miguel Servet (HUMS)
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ZaragozaSpainNot yet recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
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BordeauxFranceNot yet recruiting
Centre Georges François Leclerc
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DijonFranceNot yet recruiting
UNICANCER - Centre Leon Berard (CLB)
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LyonFranceNot yet recruiting
Hopitaux de Marseille AP-HM - Hopital de La Timone
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MarseilleFranceNot yet recruiting
ICM - Institut du Cancer de Montpellier
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MontpellierFranceNot yet recruiting
Institut Curie
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ParisFranceNot yet recruiting
Institution: Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
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Saint-HerblainFranceNot yet recruiting
University Hospitals Birmingham -Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomNot yet recruiting
Cambridge University Hospitals
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CambridgeUnited KingdomNot yet recruiting
Cancer Research UK Scotland Institute (Formerly the Cancer Research UK Beatson Institute)
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GlasgowUnited KingdomNot yet recruiting
The Clatterbridge Cancer Centre
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LiverpoolUnited KingdomNot yet recruiting
The Royal Marsden
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LondonUnited KingdomNot yet recruiting
Barts Health NHS Trust
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LondonUnited KingdomNot yet recruiting
The Christie Hospital
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ManchesterUnited KingdomNot yet recruiting
Nottingham City Hospital
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NottinghamUnited KingdomNot yet recruiting
The Royal Marsden
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SuttonUnited KingdomNot yet recruiting
Semmelweis Egyetem
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BudapestHungaryNot yet recruiting
Orszagos Onkologiai Intezet (National Institute of Oncology)
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BudapestHungaryNot yet recruiting
Debreceni Egyetem Klinikai Kozpont
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DebrecenHungaryNot yet recruiting
Semmelweis Egyetem
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SzolnokHungaryNot yet recruiting
Ospedali riuniti di Ancona - Clinica di Oncologia Medica
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AnconaItalyNot yet recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyNot yet recruiting
Azienda Ospedaliero-Universitaria di Modena-Policlinico di Modena
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ModenaItalyNot yet recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara
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PisaItalyNot yet recruiting
Prato Santo Stefano
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PratoItalyNot yet recruiting
Gruppo Humanitas Humanitas Research Hospital Rozzano Cancer Center
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RozzanoItalyNot yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona (AOUI) - Ospedale Borgo Trento
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VeronaItalyNot yet recruiting
Kosin University Gospel Hospital
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BusanSouth KoreaNot yet recruiting
Chonbuk National University - Chonbuk National University Hospital - Jeonbuk Regional Cancer Center
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JeonjuSouth KoreaNot yet recruiting
CHA University - CHA Bundang Medical Center (Bundang CHA General Hospital)
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SeongnamSouth KoreaNot yet recruiting
Seoul National University Bundang Hospital - Comprehensive Cancer Center
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Seongnam-siSouth KoreaNot yet recruiting
Korea University Guro Hospital
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SeoulSouth KoreaNot yet recruiting
Severance Hospital Yonsei Cancer Center
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SeoulSouth KoreaNot yet recruiting
Ajou University Hospital
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SuwonSouth KoreaNot yet recruiting
Pusan National University Yangsan Hospital - Oncology/Hematology Clinic
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YangsanSouth KoreaNot yet recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE (IPO-Lisboa))
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LisbonPortugalNot yet recruiting
Centro Hospitalar Universitario de Sao Joao
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LisbonPortugalNot yet recruiting
Centro Hospitalar Universitário de São João
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PortoPortugalNot yet recruiting
Arensia Research Clinic Bucharest
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BucharestRomaniaNot yet recruiting
Arensia Research Clinic Cluj-Napoca
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Cluj-NapocaRomaniaNot yet recruiting
Clinica de Oncologie Sf Nectarie
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CraiovaRomaniaNot yet recruiting
Centrul de Oncologie Euroclinic
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IașiRomaniaNot yet recruiting
OncoHelp - Ambulator OncoMed
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TimișoaraRomaniaNot yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital - Cancer Center
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Kaohsiung CityTaiwanNot yet recruiting
Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
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Kaohsiung CityTaiwanNot yet recruiting
China Medical University Hospital
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TaichungTaiwanNot yet recruiting
Taichung Veterans General Hospital (VGHTC)
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TaichungTaiwanNot yet recruiting
Chi Mei Hospital, Liouying
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TainanTaiwanNot yet recruiting
Taipei Veterans General Hospital (VGH)
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TaipeiTaiwanNot yet recruiting
Texas Oncology
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AustinUnited StatesNot yet recruiting
Greater Baltimore Medical Center
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BaltimoreUnited StatesNot yet recruiting
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
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BaltimoreUnited StatesNot yet recruiting
Dana Faber Cancer Institute
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BostonUnited StatesNot yet recruiting
Gabrail Cancer Center and Research Center
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CantonUnited StatesRecruiting
MUSC Hollings Cancer Center
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CharlestonUnited StatesNot yet recruiting
UVA Health - Emily Couric Clinical Cancer Center
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CharlottesvilleUnited StatesNot yet recruiting
University of Chicago
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ChicagoUnited StatesNot yet recruiting
Cleveland Clinic - Main Campus
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ClevelandUnited StatesNot yet recruiting
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado
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Colorado SpringsUnited StatesNot yet recruiting
The Ohio State University Comprehensive Cancer Center The Arthur G.James
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ColumbusUnited StatesNot yet recruiting
Texas Oncology
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DallasUnited StatesNot yet recruiting
Barbara Ann Karmanos Cancer Institute - Wayne State University
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DetroitUnited StatesNot yet recruiting
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesNot yet recruiting
Prisma Health Cancer Institute Multidisciplinary Center
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GreenvilleUnited StatesNot yet recruiting
Clearview Cancer Institute
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HuntsvilleUnited StatesNot yet recruiting
Iowa Health Care Holden Comprehensive Cancer Center
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Iowa CityUnited StatesNot yet recruiting
Tennessee Cancer Specialists
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KnoxvilleUnited StatesNot yet recruiting
University of California Los Angeles Westwood Cancer Center
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Los AngelesUnited StatesNot yet recruiting
University of Louisville Health
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LouisvilleUnited StatesNot yet recruiting
Vanderbilt-Ingram Cancer Center
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NashvilleUnited StatesNot yet recruiting
Medical Oncology Hematology Consultants
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NewarkUnited StatesNot yet recruiting
Yale School of Medicine
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NewhavenUnited StatesNot yet recruiting
NYU Langone Health Perlmutter Cancer Center
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New YorkUnited StatesNot yet recruiting
Memorial Sloan Kettering
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New YorkUnited StatesNot yet recruiting
Nebraska Cancer Specialists - Methodist Estabrook Cancer Center
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OmahaUnited StatesRecruiting
Florida Cancer Specialists and Research Institute
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OrlandoUnited StatesRecruiting
Stanford Medicine Cancer Center
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Palo AltoUnited StatesNot yet recruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesNot yet recruiting
Penn-Medicine - Abramson Cancer Center University of Pennsylvania
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PhiladelphiaUnited StatesNot yet recruiting
Mayo Clinic in Rochester
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RochesterUnited StatesNot yet recruiting
Moores Cancer Center
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San DiegoUnited StatesNot yet recruiting
UCSF Head and Neck Surgery Cancer Program
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San FranciscoUnited StatesNot yet recruiting
Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance
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SeattleUnited StatesNot yet recruiting
Washington University in St. Louis
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St LouisUnited StatesNot yet recruiting
Moffitt Cancer Center - Magnolia Campus
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TampaUnited StatesNot yet recruiting
The University of Arizona Cancer Center
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TucsonUnited StatesNot yet recruiting
Northwest Cancer Center
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VancouverUnited StatesNot yet recruiting

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