New hope for head and neck cancer: drug may prevent recurrence after chemoradiation
NCT ID NCT06256588
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug dostarlimab, given after standard chemoradiation, can help prevent head and neck cancer from coming back or spreading. About 864 adults with advanced but not surgically removable head and neck cancer will receive either dostarlimab or a placebo. The main goal is to see if dostarlimab improves the time patients stay cancer-free.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 864 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease. * Has provided acceptable core or excisional biopsy obtained prior to CRT: * PD-L1 positive tumor status * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has adequate organ function. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible. * Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer. Has more than one primary HNSCC tumor. * Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary. * Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization. * Has any history of interstitial lung disease or pneumonitis (past or current). * Has cirrhosis of any stage or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. * Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator. * Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention. * Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\] * Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention. * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced unresected head and neck squamous cell carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
256 sites in 31 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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GSK Investigational Site
RECRUITINGJonesboro, Arkansas, 72401, United States
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RECRUITINGLos Angeles, California, 90095, United States
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RECRUITINGSolvang, California, 93463, United States
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RECRUITINGStockton, California, 95204, United States
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RECRUITINGTorrance, California, 90505, United States
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RECRUITINGFarmington, Connecticut, 06030-1628, United States
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RECRUITINGNew Haven, Connecticut, 06520, United States
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RECRUITINGWashington D.C., District of Columbia, 20010, United States
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RECRUITINGSt. Petersburg, Florida, 33709, United States
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WITHDRAWNTamarac, Florida, 33321, United States
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RECRUITINGAtlanta, Georgia, 30322, United States
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RECRUITINGFort Wayne, Indiana, 46804, United States
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RECRUITINGIowa City, Iowa, 52242, United States
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RECRUITINGLexington, Kentucky, 40536, United States
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RECRUITINGColumbia, Maryland, 21044, United States
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RECRUITINGWorcester, Massachusetts, 01655-0002, United States
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RECRUITINGSt Louis, Missouri, 63110, United States
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RECRUITINGOmaha, Nebraska, 68114, United States
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COMPLETEDNew York, New York, 10032, United States
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RECRUITINGThe Bronx, New York, 10468, United States
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RECRUITINGCanton, Ohio, 44718, United States
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COMPLETEDCincinnati, Ohio, 45219, United States
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RECRUITINGTulsa, Oklahoma, 74146, United States
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RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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RECRUITINGCharleston, South Carolina, 29425, United States
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COMPLETEDGreenville, South Carolina, 29607, United States
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RECRUITINGChattanooga, Tennessee, 37404, United States
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RECRUITINGGermantown, Tennessee, 38138, United States
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RECRUITINGNashville, Tennessee, 37203, United States
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RECRUITINGDallas, Texas, 75246, United States
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RECRUITINGFort Worth, Texas, 76104, United States
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RECRUITINGSan Antonio, Texas, 78217, United States
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RECRUITINGFredericksburg, Virginia, 22408, United States
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RECRUITINGWytheville, Virginia, 24382, United States
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WITHDRAWNTacoma, Washington, 98405, United States
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RECRUITINGBuenos Aires, 1023, Argentina
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RECRUITINGBuenos Aires, C1425, Argentina
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RECRUITINGBuenos Aires, C1437GZT, Argentina
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RECRUITINGCiudad Autonoma de Buenos Aire, C1426, Argentina
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RECRUITINGCórdoba, 5000, Argentina
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RECRUITINGFlorida, 1602, Argentina
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RECRUITINGRosario, S2002, Argentina
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RECRUITINGSan Juan, J5400, Argentina
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RECRUITINGSan Miguel de Tucumán, T4000GTB, Argentina
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RECRUITINGViedma, R8500ACE, Argentina
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RECRUITINGBlacktown, New South Wales, 2148, Australia
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RECRUITINGDouglas, Queensland, 4814, Australia
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WITHDRAWNHerston, Queensland, 4029, Australia
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RECRUITINGBallarat, Victoria, 3350, Australia
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RECRUITINGGeelong, Victoria, 3220, Australia
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COMPLETEDMelbourne, Victoria, 3004, Australia
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RECRUITINGBrussels, 1200, Belgium
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RECRUITINGCharleroi, 6060, Belgium
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RECRUITINGEdegem, 2650, Belgium
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RECRUITINGGhent, 9000, Belgium
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RECRUITINGLiège, 4000, Belgium
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RECRUITINGYvoir, 5530, Belgium
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RECRUITINGBarretos, 14784-400, Brazil
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RECRUITINGBelo Horizonte, 30110-022, Brazil
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RECRUITINGFlorianópolis, 88020-210, Brazil
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RECRUITINGIjuí, 98700-000, Brazil
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RECRUITINGJaú, 17210-120, Brazil
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RECRUITINGJoinville, 89201-260, Brazil
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RECRUITINGNatal, 59075-740, Brazil
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RECRUITINGPorto Alegre, 90610-000, Brazil
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RECRUITINGSalvador, 41253-190, Brazil
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RECRUITINGSalvador, 41950-640, Brazil
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RECRUITINGSão José do Rio Preto, 15090-200, Brazil
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RECRUITINGSão Paulo, 01246-000, Brazil
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RECRUITINGVitória, 29043-260, Brazil
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RECRUITINGGreater Sudbury, Ontario, P3E 5J1, Canada
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RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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RECRUITINGToronto, Ontario, M5G 2M9, Canada
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COMPLETEDMontreal, Quebec, H3T 1E2, Canada
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RECRUITINGChongqing, Chongqing Municipality, 400030, China
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RECRUITINGBaoding, Hebei, 071000, China
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RECRUITINGNanyang, Henan, 473005, China
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RECRUITINGBeijing, 100036, China
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RECRUITINGChangsha, 410013, China
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RECRUITINGChangzhou, 213032, China
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RECRUITINGChengdu, 610000, China
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RECRUITINGChengdu, 610041, China
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RECRUITINGDongguan, 523059, China
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RECRUITINGFuzhou, 350005, China
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ACTIVE_NOT_RECRUITINGFuzhou, 350014, China
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RECRUITINGGuangzhou, 510120, China
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RECRUITINGGuangzhou, 510503, China
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RECRUITINGHangzhou, 310003, China
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RECRUITINGHangzhou, 310022, China
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RECRUITINGHefei, 230001, China
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RECRUITINGHengyang, 421000, China
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RECRUITINGJinan, 250117, China
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RECRUITINGKunming, 650106, China
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ACTIVE_NOT_RECRUITINGLanzhou, 730030, China
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RECRUITINGLinyi, 276002, China
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RECRUITINGNanchang, 330006, China
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RECRUITINGNanchang, 330029, China
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RECRUITINGNanning, 530021, China
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RECRUITINGShanghai, 200032, China
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RECRUITINGTaiyuan, 030013, China
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RECRUITINGWuhan, 430030, China
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RECRUITINGWuhan, 430079, China
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RECRUITINGXiamen, 361004, China
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RECRUITINGXuzhou, 221004, China
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RECRUITINGZhengzhou, 450052, China
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RECRUITINGZhuhai, 519001, China
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WITHDRAWNOlomouc, 779 00, Czechia
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RECRUITINGPrague, 10034, Czechia
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RECRUITINGPrague, 150 08, Czechia
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RECRUITINGPrague, 180 81, Czechia
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RECRUITINGZlín, 76275, Czechia
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RECRUITINGArs-Laquenexy, 57530, France
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RECRUITINGCaen, 14075, France
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RECRUITINGDijon, 21079, France
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RECRUITINGMarseille, 13005, France
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RECRUITINGPoitiers, 86021, France
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RECRUITINGQuimper, 29000, France
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RECRUITINGRennes, 35042, France
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RECRUITINGRouen, 76038, France
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COMPLETEDVandœuvre-lès-Nancy, 54519, France
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RECRUITINGAugsburg, 86156, Germany
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RECRUITINGBerlin, 12351, Germany
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RECRUITINGBerlin, 13353, Germany
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RECRUITINGErlangen, 91054, Germany
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RECRUITINGEssen, 45147, Germany
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RECRUITINGGiessen, 35392, Germany
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RECRUITINGHamburg, 22087, Germany
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WITHDRAWNNeuruppin, 16816, Germany
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RECRUITINGStraubing, 94315, Germany
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RECRUITINGAthens, 115 22, Greece
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RECRUITINGAthens, 12462, Greece
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RECRUITINGLarissa, 41100, Greece
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RECRUITINGThessaloniki, 564 29, Greece
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RECRUITINGGyőr, 9023, Hungary
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RECRUITINGKaposvár, 7400, Hungary
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RECRUITINGNyíregyháza, H-4400, Hungary
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RECRUITINGMumbai, Maharashtra, 400071, India
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RECRUITINGPune, Maharashtra, 411001, India
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RECRUITINGBengaluru, 560066, India
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RECRUITINGBhubaneswar, 751019, India
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RECRUITINGGurgaon, 122001, India
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RECRUITINGHyderabad, 500004, India
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RECRUITINGMumbai, 400012, India
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RECRUITINGNashik, 422002, India
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RECRUITINGNehru Nagar Belagavi Karnataka 590010, 590010, India
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RECRUITINGSurat, 395002, India
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RECRUITINGVijayawada, 520002, India
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RECRUITINGAshdod, 7747629, Israel
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RECRUITINGHaifa, 3109601, Israel
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WITHDRAWNJerusalem, 9112001, Israel
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RECRUITINGTel Aviv, 64239, Israel
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RECRUITINGBolzano, Prov. Aut. Bolzano-Alto Adige, 39100, Italy
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RECRUITINGBologna, 40139, Italy
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RECRUITINGMilan, 20133, Italy
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RECRUITINGMilan, 20141, Italy
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WITHDRAWNNaples, 80131, Italy
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RECRUITINGPavia, 27100, Italy
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RECRUITINGPrato, 59100, Italy
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RECRUITINGRoma, 00161, Italy
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RECRUITINGRoma, 00168, Italy
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RECRUITINGRozzano MI, 20089, Italy
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RECRUITINGSavona, 17100, Italy
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RECRUITINGAichi, 464-8681, Japan
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RECRUITINGAomori, 036-8563, Japan
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RECRUITINGChiba, 260-8717, Japan
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RECRUITINGChiba, 277-8577, Japan
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RECRUITINGEhime, 791-0280, Japan
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RECRUITINGFukuoka, 812-8582, Japan
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RECRUITINGGunma, 371-8511, Japan
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RECRUITINGHokkaido, 060-8648, Japan
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RECRUITINGHyōgo, 650-0017, Japan
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RECRUITINGHyōgo, 673-8558, Japan
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RECRUITINGKagoshima, 890-8520, Japan
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RECRUITINGKanagawa, 236-0004, Japan
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RECRUITINGKanagawa, 252-0375, Japan
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RECRUITINGKanagawa, 259-1193, Japan
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RECRUITINGKyoto, 612-8555, Japan
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RECRUITINGMiyagi, 981-1293, Japan
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COMPLETEDNiigata, 951-8520, Japan
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COMPLETEDNumakunai, 028-3695, Japan
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ACTIVE_NOT_RECRUITINGOkinawa, 901-2725, Japan
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RECRUITINGOsaka, 541-8567, Japan
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RECRUITINGSaitama, 350-1298, Japan
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RECRUITINGShizuoka, 411-8777, Japan
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RECRUITINGTokyo, 105-8471, Japan
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RECRUITINGTokyo, 113-8519, Japan
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RECRUITINGTokyo, 152-8902, Japan
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RECRUITINGTokyo, 160-0023, Japan
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RECRUITINGTottori, 683-8504, Japan
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RECRUITINGGuadajalara, 44280, Mexico
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RECRUITINGGuadalajara, 44650, Mexico
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RECRUITINGMexico City, 06760, Mexico
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RECRUITINGMexico City, 11510, Mexico
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RECRUITINGMonterrey, 66260, Mexico
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RECRUITINGOaxaca City, 68020, Mexico
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RECRUITINGBergen, 5021, Norway
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RECRUITINGOslo, 0379, Norway
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RECRUITINGTroms, 9038, Norway
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RECRUITINGBielsko-Biala, 43-300, Poland
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RECRUITINGGliwice, 44-102, Poland
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RECRUITINGKatowice, 40-514, Poland
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RECRUITINGOlsztyn, 10-228, Poland
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RECRUITINGPrzemyśl, 37-700, Poland
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RECRUITINGSiedlce, 08-110, Poland
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RECRUITINGWarsaw, 04-141, Poland
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RECRUITINGCoimbra, 3000-075, Portugal
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RECRUITINGFaro, 8000-386, Portugal
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RECRUITINGLisbon, 1649-035, Portugal
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RECRUITINGLisbon, 1998-018, Portugal
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RECRUITINGMatosinhos Municipality, 4464-509, Portugal
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RECRUITINGPorto, 4200-072, Portugal
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RECRUITINGPorto, 4200-319, Portugal
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RECRUITINGVila Nova de Gaia, 4434-502, Portugal
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RECRUITINGBucharest, 013823, Romania
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RECRUITINGBucharest, 020142, Romania
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RECRUITINGCraiova, 200508, Romania
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RECRUITINGCraiova, 200542, Romania
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WITHDRAWNFloreşti, 407280, Romania
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RECRUITINGIași, 700483, Romania
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RECRUITINGOradea, 410469, Romania
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RECRUITINGPiteşti, 110283, Romania
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RECRUITINGSuceava, 720214, Romania
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RECRUITINGTimișoara, 300239, Romania
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RECRUITINGRiyadh, 12372, Saudi Arabia
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RECRUITINGRiyadh, Saudi Arabia
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RECRUITINGSingapore, 168583, Singapore
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RECRUITINGSingapore, 308433, Singapore
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RECRUITINGBusan, 602-030, South Korea
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WITHDRAWNPusan, 49241, South Korea
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RECRUITINGSeoul, 03722, South Korea
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RECRUITINGSeoul, 06351, South Korea
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RECRUITINGSeoul, 110 744, South Korea
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RECRUITINGSuwon Gyeonggi-do, 16247, South Korea
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RECRUITINGBaracaldoVizcaya, 48903, Spain
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RECRUITINGBarcelona, 08023, Spain
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RECRUITINGCartagena Murcia, 30202, Spain
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RECRUITINGHebrOn, 08035, Spain
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RECRUITINGJerez de la Frontera, 11407, Spain
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RECRUITINGL'Hospitalet de Llobrega, 08908, Spain
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RECRUITINGLugo, 27003, Spain
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RECRUITINGMadrid, 28040, Spain
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RECRUITINGMadrid, 28041, Spain
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RECRUITINGMadrid, 28046, Spain
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RECRUITINGPamplona, 31008, Spain
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RECRUITINGSalamanca, 37007, Spain
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RECRUITINGSantander, 39008, Spain
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RECRUITINGZaragoza, 50009, Spain
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RECRUITINGGothenburg, SE-413 45, Sweden
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RECRUITINGStockholm, SE-171 64, Sweden
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RECRUITINGUppsala, SE-751 85, Sweden
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RECRUITINGBasel, 4031, Switzerland
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RECRUITINGFribourg, 1708, Switzerland
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RECRUITINGGeneva, 1211, Switzerland
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RECRUITINGLausanne, 1011, Switzerland
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RECRUITINGZurich, 8091, Switzerland
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RECRUITINGChanghua, 500, Taiwan
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RECRUITINGKaohsiung City, 833, Taiwan
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RECRUITINGTaichung, 40447, Taiwan
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RECRUITINGTaipei, 100, Taiwan
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RECRUITINGAdapazarı, Turkey (Türkiye)
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RECRUITINGAnkara, 06010, Turkey (Türkiye)
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RECRUITINGAnkara, 06100, Turkey (Türkiye)
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GSK Investigational Site
RECRUITINGAnkara, 06520, Turkey (Türkiye)
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GSK Investigational Site
RECRUITINGAntalya, 7050, Turkey (Türkiye)
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GSK Investigational Site
RECRUITINGIstanbul, 34010, Turkey (Türkiye)
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GSK Investigational Site
RECRUITINGIstanbul, 34662, Turkey (Türkiye)
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GSK Investigational Site
RECRUITINGIstanbul, Şişli, 34384, Turkey (Türkiye)
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GSK Investigational Site
RECRUITINGAbu Dhabi, United Arab Emirates
-
GSK Investigational Site
RECRUITINGAl Ain City, United Arab Emirates
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GSK Investigational Site
RECRUITINGDubai, United Arab Emirates
-
GSK Investigational Site
RECRUITINGEdinburgh, EH4 2XU, United Kingdom
-
GSK Investigational Site
RECRUITINGGloucester, GL1 3NN, United Kingdom
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GSK Investigational Site
RECRUITINGLondon, SW3 6JJ, United Kingdom
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GSK Investigational Site
RECRUITINGNottingham, NG5 1PB, United Kingdom
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GSK Investigational Site
RECRUITINGSutton, SM2 5PT, United Kingdom
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GSK Investigational Site
WITHDRAWNWolverhampton, WV10 0QP, United Kingdom
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