Could a single drug replace chemo for some colon cancers?
NCT ID NCT05855200
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests the immunotherapy drug dostarlimab against standard chemotherapy in 892 people with a specific type of colon cancer (dMMR/MSI-H) that has not spread. The goal is to see if dostarlimab alone can prevent cancer from coming back or causing death. Participants will receive either dostarlimab or standard chemo before and after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dostarlimab
- What this could lead to
- If successful, this could offer a chemotherapy-free option for certain colon cancers, potentially reducing side effects and improving outcomes.
- What could go wrong
- This is an early-phase trial, and results may not confirm benefit. Risks include immune-related side effects from dostarlimab, and it may not work for all participants.
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 892 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Mar 2031
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: * Has untreated pathologically confirmed colon adenocarcinoma * Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III * Has radiologically evaluable disease * Has a tumor demonstrating the presence of either dMMR status or MSI-H Exclusion Criteria: * Has distant metastatic disease. * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer * Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible. * Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization * Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis. * Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice * Has a history of allogenic stem cell transplantation or organ transplantation * 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 * Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study * 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, or any components of FOLFOX or CAPEOX
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colon adenocarcinoma 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
229 sites in 27 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
RECRUITINGTucson, Arizona, 85715, United States
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RECRUITINGLos Angeles, California, 90027, United States
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RECRUITINGNew Haven, Connecticut, 06520, United States
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WITHDRAWNWashington D.C., District of Columbia, 20010, United States
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WITHDRAWNDeerfield Beach, Florida, 33064, United States
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WITHDRAWNFort Lauderdale, Florida, 33316, United States
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WITHDRAWNMarietta, Georgia, 30060, United States
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RECRUITINGChicago, Illinois, 60611, United States
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RECRUITINGChicago, Illinois, 60612, United States
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WITHDRAWNChicago, Illinois, 60637, United States
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RECRUITINGNaperville, Illinois, 60126, United States
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RECRUITINGNaperville, Illinois, 60540, United States
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RECRUITINGWestwood, Kansas, 66205, United States
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WITHDRAWNLexington, Kentucky, 40503, United States
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WITHDRAWNLouisville, Kentucky, 40206, United States
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WITHDRAWNBaton Rouge, Louisiana, 70809, United States
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RECRUITINGBethesda, Maryland, 20817, United States
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WITHDRAWNAnn Arbor, Michigan, 48109, United States
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RECRUITINGDetroit, Michigan, 48202, United States
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RECRUITINGMinneapolis, Minnesota, 55455, United States
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WITHDRAWNJoplin, Missouri, 64804, United States
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WITHDRAWNSt Louis, Missouri, 63128, United States
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WITHDRAWNSt Louis, Missouri, 63141, United States
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RECRUITINGGrand Island, Nebraska, 68803, United States
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RECRUITINGOmaha, Nebraska, 68130, United States
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WITHDRAWNOmaha, Nebraska, 68198, United States
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WITHDRAWNLebanon, New Hampshire, 03756, United States
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RECRUITINGNew York, New York, 10028, United States
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RECRUITINGNew York, New York, 10469, United States
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RECRUITINGNew York, New York, 11042, United States
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RECRUITINGNew York, New York, 11967, United States
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RECRUITINGThe Bronx, New York, 10461, United States
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RECRUITINGDurham, North Carolina, 27710, United States
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RECRUITINGAkron, Ohio, 44304, United States
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RECRUITINGCincinnati, Ohio, 45220, United States
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WITHDRAWNCleveland, Ohio, 44111, United States
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WITHDRAWNCleveland, Ohio, 44142, United States
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WITHDRAWNCleveland, Ohio, 44196, United States
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WITHDRAWNOklahoma City, Oklahoma, 73104, United States
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WITHDRAWNOklahoma City, Oklahoma, 73120, United States
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WITHDRAWNPittsburgh, Pennsylvania, 15212, United States
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RECRUITINGSioux Falls, South Dakota, 57078, United States
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RECRUITINGSioux Falls, South Dakota, 57105, United States
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RECRUITINGSioux Falls, South Dakota, 57401, United States
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RECRUITINGSioux Falls, South Dakota, 57501, United States
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WITHDRAWNDallas, Texas, 75235, United States
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COMPLETEDDallas, Texas, 75390, United States
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RECRUITINGRichmond, Virginia, 23229, United States
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RECRUITINGAppleton, Wisconsin, 54911, United States
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RECRUITINGBuenos Aires, 1093, Argentina
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RECRUITINGBuenos Aires, C1180AAX, Argentina
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RECRUITINGBuenos Aires, C1181ACH, Argentina
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RECRUITINGCapital Federal, C1426ANZ, Argentina
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COMPLETEDCiudad Autonoma de Buenos Aire, C1431FWO, Argentina
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RECRUITINGCórdoba, 5000, Argentina
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RECRUITINGMar del Plata, 7600, Argentina
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RECRUITINGRosario, S2002, Argentina
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RECRUITINGSan Miguel de Tucumán, T4000IHE, Argentina
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RECRUITINGSanta Fe, S3000FUJ, Argentina
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RECRUITINGNewcastle, New South Wales, 2298, Australia
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WITHDRAWNSt Leonards, New South Wales, 2065, Australia
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RECRUITINGWoolangabba, Queensland, 4102, Australia
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RECRUITINGHeidelberg, Victoria, 3084, Australia
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WITHDRAWNMelbourne, Victoria, 3004, Australia
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RECRUITINGAalst, 9300, Belgium
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RECRUITINGBrussels, 1070, Belgium
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RECRUITINGBrussels, 1200, Belgium
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RECRUITINGEdegem, 2650, Belgium
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RECRUITINGGhent, 9000, Belgium
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RECRUITINGLeuven, 3000, Belgium
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RECRUITINGLiège, 4000, Belgium
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RECRUITINGRoeselare, 8800, Belgium
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RECRUITINGBarretos, 14784-400, Brazil
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RECRUITINGBelém, 66.073-005, Brazil
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RECRUITINGCampo Grande, 79002-061, Brazil
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RECRUITINGLages, 88501-001, Brazil
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RECRUITINGNatal, 59075-740, Brazil
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RECRUITINGPorto Alegre, 90610-000, Brazil
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RECRUITINGSalvador, 40414-120, Brazil
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RECRUITINGSão José do Rio Preto, 15090-000, Brazil
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RECRUITINGSão Paulo, 01509-010, Brazil
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RECRUITINGSão Paulo, 04312903, Brazil
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RECRUITINGTeresina, 64049-200, Brazil
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RECRUITINGVitória, 29043-260, Brazil
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GSK Investigational Site
WITHDRAWNEdmonton, Alberta, T6G 1Z2, Canada
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GSK Investigational Site
RECRUITINGHalifax, Nova Scotia, B3H 1V7, Canada
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GSK Investigational Site
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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GSK Investigational Site
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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GSK Investigational Site
RECRUITINGBeijing, 100036, China
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RECRUITINGBeijing, 100083, China
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RECRUITINGBeijing, 100730, China
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RECRUITINGChangchun, 130021, China
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RECRUITINGChangsha, 410013, China
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RECRUITINGChengdu, 610041, China
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RECRUITINGChongqing, 400042, China
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RECRUITINGChongqing, 400042, China
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RECRUITINGGuangzhou, 510060, China
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RECRUITINGGuangzhou, 510655, China
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RECRUITINGHangzhou, 310016, China
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RECRUITINGHangzhou, 310022, China
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RECRUITINGHangzhou, 311100, China
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RECRUITINGHangzhou, China
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RECRUITINGHarbin, 150000, China
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RECRUITINGJinan, 250117, China
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RECRUITINGKunming, 650106, China
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RECRUITINGMeizhou, 514700, China
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RECRUITINGNanchang, 330006, China
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RECRUITINGNanchang, 330029, China
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RECRUITINGShanghai, 200032, China
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RECRUITINGShanghai, 200032, China
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RECRUITINGShenzhen, 518036, China
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RECRUITINGTaiyuan, 030013, China
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RECRUITINGTianjin, 300000, China
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RECRUITINGWuhan, 430030, China
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GSK Investigational Site
RECRUITINGXiamen, 361004, China
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RECRUITINGYangzhou, 225001, China
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RECRUITINGZhengzhou, 450052, China
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RECRUITINGHradec Králové, 500 05, Czechia
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GSK Investigational Site
RECRUITINGNový Jičín, 741 01, Czechia
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RECRUITINGPrague, 150 06, Czechia
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RECRUITINGTallinn, 11312, Estonia
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RECRUITINGTallinn, 13419, Estonia
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RECRUITINGTartu, 50501, Estonia
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RECRUITINGHelsinki, 00029, Finland
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RECRUITINGTampere, 33520, Finland
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RECRUITINGTurku, 20521, Finland
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RECRUITINGLyon, 69008, France
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RECRUITINGMarseille, 13385, France
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RECRUITINGNantes, 44093, France
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RECRUITINGParis, 75015, France
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RECRUITINGPessac, 33604, France
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RECRUITINGRennes, 35042, France
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COMPLETEDRouen, 76000, France
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RECRUITINGSaint-Priest-en-Jarez, 42270, France
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RECRUITINGSuresnes, 92150, France
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RECRUITINGToulouse, 31059, France
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RECRUITINGVillejuif, 94805, France
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RECRUITINGBerlin, 13353, Germany
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RECRUITINGDüsseldorf, 40225, Germany
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GSK Investigational Site
RECRUITINGFrankfurt, 60488, Germany
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WITHDRAWNHalle, 06120, Germany
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RECRUITINGLübeck, 23562, Germany
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GSK Investigational Site
RECRUITINGMannheim, 68167, Germany
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GSK Investigational Site
RECRUITINGMünchen, 81377, Germany
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GSK Investigational Site
RECRUITINGMünchen, 81737, Germany
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GSK Investigational Site
COMPLETEDAthens, 11528, Greece
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GSK Investigational Site
COMPLETEDThessaloniki, 54639, Greece
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GSK Investigational Site
COMPLETEDThessaloniki, 570 10, Greece
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GSK Investigational Site
RECRUITINGBengaluru, Karnataka, 560076, India
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GSK Investigational Site
RECRUITINGLudhiana, Punjab, 141123, India
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RECRUITINGBelagavi, 590010, India
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RECRUITINGHyderabad, 500034, India
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RECRUITINGNashik, 422002, India
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RECRUITINGPune, 411040, India
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RECRUITINGCagliari, 09042, Italy
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RECRUITINGGenova, 16132, Italy
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RECRUITINGMilan, 20162, Italy
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RECRUITINGNaples, 80131, Italy
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RECRUITINGPadova, 35128, Italy
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GSK Investigational Site
RECRUITINGPisa, 56126, Italy
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GSK Investigational Site
RECRUITINGReggio Emilia, 40123, Italy
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GSK Investigational Site
RECRUITINGRoma, 00152, Italy
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GSK Investigational Site
RECRUITINGRoma, 00168, Italy
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GSK Investigational Site
RECRUITINGRozzano MI, 20089, Italy
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GSK Investigational Site
RECRUITINGAichi, 464-8681, Japan
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RECRUITINGChiba, 277-8577, Japan
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RECRUITINGFukuoka, 812-8582, Japan
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RECRUITINGHokkaido, 060-8648, Japan
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WITHDRAWNHyōgo, 650-0047, Japan
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RECRUITINGIbaraki, 309-1793, Japan
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RECRUITINGKanagawa, 216-8511, Japan
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RECRUITINGKanagawa, 232-0024, Japan
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RECRUITINGKyoto, 606-8507, Japan
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RECRUITINGOkayama, 710-8602, Japan
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RECRUITINGOsaka, 540-0006, Japan
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RECRUITINGOsaka, 541-8567, Japan
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RECRUITINGOsaka, 558-8558, Japan
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RECRUITINGOsaka, 565-0871, Japan
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RECRUITINGOsaka, 573-1191, Japan
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RECRUITINGShizuoka, 411-8777, Japan
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RECRUITINGTokyo, 104-0045, Japan
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RECRUITINGTokyo, 135-8550, Japan
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RECRUITINGDF, 14000, Mexico
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RECRUITINGGuadalajara, 44280, Mexico
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COMPLETEDGuadalajara, 44650, Mexico
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RECRUITINGMexico City, 03100, Mexico
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RECRUITINGOaxaca City, 68020, Mexico
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COMPLETEDSan Pedro Garza García, 66220, Mexico
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RECRUITINGTijuana, 22010, Mexico
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RECRUITINGBreda, 4818 CK, Netherlands
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RECRUITINGMaastricht, 6229 HX, Netherlands
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RECRUITINGNijmegen, 6525 GA, Netherlands
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RECRUITINGUtrecht, 3584 CX, Netherlands
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RECRUITINGBergen, 5021, Norway
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RECRUITINGKristiansand, 4604, Norway
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RECRUITINGLrenskog, 1474, Norway
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RECRUITINGOslo, 0407, Norway
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RECRUITINGStavanger, 4011, Norway
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WITHDRAWNTromsø, 9019, Norway
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RECRUITINGPunta Pacifica Panama City Panama, Panama
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RECRUITINGBydgoszcz, 85-048, Poland
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RECRUITINGWarsaw, 02-034, Poland
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RECRUITINGAlmada, 2805-267, Portugal
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RECRUITINGCoimbra, 3000-075, Portugal
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RECRUITINGLisbon, 1649-035, Portugal
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RECRUITINGDaegu, 41404, South Korea
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RECRUITINGGyeonggi-do, 463712, South Korea
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RECRUITINGSeoul, 06351, South Korea
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RECRUITINGSeoul, 06591, South Korea
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RECRUITINGSeoul, 138-736, South Korea
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RECRUITINGBadajoz, 06080, Spain
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RECRUITINGBaracaldoVizcaya, 48903, Spain
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RECRUITINGBarcelona, 08026, Spain
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RECRUITINGBarcelona, 08035, Spain
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RECRUITINGBarcelona, 08036, Spain
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RECRUITINGCórdoba, 14004, Spain
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RECRUITINGDonostia / San Sebastian, 20080, Spain
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RECRUITINGElche Alicante, 03203, Spain
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RECRUITINGGranada, 18014, Spain
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RECRUITINGJaén, 23007, Spain
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RECRUITINGL'Hospitalet de Llobrega, 08908, Spain
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RECRUITINGLas Palmas de Gran Canar, 35016, Spain
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RECRUITINGMadrid, 28006, Spain
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RECRUITINGMadrid, 28009, Spain
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RECRUITINGMadrid, 28034, Spain
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RECRUITINGMadrid, 28040, 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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RECRUITINGMadrid, 28050, Spain
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RECRUITINGMadrid, 28222, Spain
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RECRUITINGMálaga, 29010, Spain
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RECRUITINGOviedo, 33011, Spain
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RECRUITINGPamplona, 31008, Spain
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RECRUITINGSantander, 39011, Spain
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RECRUITINGSeville, 41013, Spain
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RECRUITINGValencia, 46009, Spain
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RECRUITINGValencia, 46010, Spain
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RECRUITINGValencia, 46014, Spain
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RECRUITINGZaragoza, 50009, Spain
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WITHDRAWNEskilstuna, 63349, Sweden
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RECRUITINGGothenburg, SE-413 45, Sweden
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RECRUITINGLinköping, SE-581 85, Sweden
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RECRUITINGMalmö, 20502, Sweden
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WITHDRAWNStockholm, 11219, Sweden
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RECRUITINGStockholm, 11883, Sweden
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RECRUITINGUppsala, SE-751 85, Sweden
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RECRUITINGKaohsiung City, 833, Taiwan
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RECRUITINGTainan, 704, Taiwan
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RECRUITINGTaipei, 100, Taiwan
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RECRUITINGTaoyuan, 333, Taiwan
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RECRUITINGAnkara, 06010, Turkey (Türkiye)
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RECRUITINGAnkara, 06230, Turkey (Türkiye)
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RECRUITINGAnkara, Turkey (Türkiye)
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RECRUITINGIstanbul, 34722, Turkey (Türkiye)
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RECRUITINGBirmingham, B9 5SS, United Kingdom
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RECRUITINGChelmsford, CM1 7ET, United Kingdom
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RECRUITINGCheltenham, GL53 7AN, United Kingdom
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RECRUITINGEdinburgh, EH4 2XU, United Kingdom
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RECRUITINGHull, HU16 5JQ, United Kingdom
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RECRUITINGLeeds West Yorkshire, LS9 7TF, United Kingdom
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RECRUITINGLondon, NW3 2QG, United Kingdom
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RECRUITINGLondon, SW3 6JJ, United Kingdom
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RECRUITINGManchester, M20 4BX, United Kingdom
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RECRUITINGSutton, SM2 5PT, United Kingdom
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