A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007).
- Conditions
- Carcinoma, Squamous CellSkin Neoplasms
- Interventions
- Registration Number
- NCT06295809
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms intismeran autogene plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of intismeran autogene in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that intismeran autogene plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to intismeran autogene plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1012
- Has a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
- Has LA Stage II-IV (M0) cSCC without distant metastases.
- cSCC must be amenable to surgery (resectable) with curative intent.
- Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available or is able to provide one that is suitable for the Next-generation Sequencing (NGS) required for this study.
- For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving adjuvant radiation therapy (RT), and for ≥3 months after the last dose of study intervention
- Is female and not pregnant/breastfeeding and at least one of the following applies during the study : is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) at least during use of intismeran autogene: 15 days, Pembrolizumab: 120 days, Adjuvant RT, if performed: 90 days after last exposure or is a WOCBP who is abstinent from heterosexual intercourse.
- Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
- Has a life expectancy of >3 months per investigator assessment.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization.
- Has adequate organ function.
- If hepatitis B surface antigen (HBsAg) positive must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
- If there is a history of hepatitis C virus (HCV) infection, HCV viral load must be undetectable at screening
- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), or melanoma
- Has distant metastatic disease (M1), visceral and/or distant nodal
- Has received prior therapy with an anti-programmed cell death receptor 1 (anti-PD-1), anti-programmed cell death receptor ligand 1 (anti-PD-L1), or anti-programmed cell death receptor ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte associated protein 4 (CTLA-4), OX-40, CD137)
- Has received prior systemic anticancer therapy including investigational agents for cSCC before randomization
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the screening blood sample (including the NGS blood sample)
- Has received prior treatment with another cancer vaccine
- Has received prior radiotherapy to the index lesion (in-field lesion). Must have recovered from all radiation-related toxicities prior to randomization and not have had radiation pneumonitis
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- History of chronic lymphocytic leukemia (CLL)
- History of central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to either intismeran autogene or pembrolizumab and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection
- Has had a myocardial infarction within 6 months of randomization
- Has a history of allogeneic tissue/solid organ transplant
- Has not adequately recovered from major surgery or have ongoing surgical complications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab plus Intismeran autogene with SOC Pembrolizumab Participants will receive intismeran autogene 1 mg intramuscular (IM) injection every 3 weeks (q3w) for up to 6 weeks and pembrolizumab 400 mg intravenous (IV) infusion every 6 weeks (q6w) up to 12 weeks as neoadjuvant therapy prior to surgery; followed by intismeran autogene 1 mg IM injection q3w up to 21 weeks and pembrolizumab 400 mg IV infusion q6w or until discontinuation. Pembrolizumab plus Intismeran autogene with SOC Intismeran autogene Participants will receive intismeran autogene 1 mg intramuscular (IM) injection every 3 weeks (q3w) for up to 6 weeks and pembrolizumab 400 mg intravenous (IV) infusion every 6 weeks (q6w) up to 12 weeks as neoadjuvant therapy prior to surgery; followed by intismeran autogene 1 mg IM injection q3w up to 21 weeks and pembrolizumab 400 mg IV infusion q6w or until discontinuation. Pembrolizumab plus Intismeran autogene with SOC Surgery Participants will receive intismeran autogene 1 mg intramuscular (IM) injection every 3 weeks (q3w) for up to 6 weeks and pembrolizumab 400 mg intravenous (IV) infusion every 6 weeks (q6w) up to 12 weeks as neoadjuvant therapy prior to surgery; followed by intismeran autogene 1 mg IM injection q3w up to 21 weeks and pembrolizumab 400 mg IV infusion q6w or until discontinuation. Standard of Care (SOC) Surgery Participants will receive surgical resection as per local guidelines with/without adjuvant radiation therapy (RT) at investigator's discretion. Pembrolizumab with SOC Pembrolizumab Participants will receive pembrolizumab 400 mg IV infusion q6w up to 12 weeks as neoadjuvant therapy prior to surgery; followed by pembrolizumab 400 mg IV infusion q6w or until discontinuation. Pembrolizumab with SOC Surgery Participants will receive pembrolizumab 400 mg IV infusion q6w up to 12 weeks as neoadjuvant therapy prior to surgery; followed by pembrolizumab 400 mg IV infusion q6w or until discontinuation.
- Primary Outcome Measures
Name Time Method Event Free Survival (EFS) Up to ~59 months EFS is defined as the time from randomization to any of the following events as assessed by the investigator: progression of disease that precludes surgery, or inability to undergo R0 or R1 surgical resection; disease recurrence (local, regional, or distant); new primary high-risk cSCC; death due to any cause. EFS will be presented.
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR) Up to ~38 months ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR). ORR will be presented.
Freedom from surgery (FFS) rate Up to ~38 months FFS rate is defined as the proportion of participants with clinical CR with no residual tumor on clinical exam and imaging with the confirmation of negative biopsy. FFS rate will be presented.
Pathological complete response (pCR) rate Up to ~38 months pCR rate is defined as the proportion of participants who have complete absence of viable tumor in the surgical resection specimen. The pCR rate will be presented.
Major pathological response (mPR) rate Up to ~38 months mPR rate is defined as the proportion of participants who have ≤10% of viable tumor cells in the surgical resection specimen. The mPR rate will be presented.
Disease-free survival (DFS) Up to ~59 months DFS is defined as the time from surgery for participants who are free of disease (R0 or R1 resection) at completion of neoadjuvant therapy, or from negative biopsy for participants who are free from surgery to first recurrence (local, regional, or distant), new primary high-risk cSCC or death due to any cause, whichever occurs first. DFS will be presented.
Disease-specific survival (DSS) Up to ~59 months DSS is defined as time from randomization to death due to progression of cancer under study. DSS will be presented.
Overall Survival (OS) Up to ~59 months OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
Percentage of participants who experience and adverse event (AE) Up to ~59 months An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Percentage of participants who discontinue study intervention due to AEs Up to ~19 months An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue intervention due to an AE will be reported.
Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30) Baseline and up to ~38 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Change from baseline in physical functioning score of QLQ (C30 Items 1-5) Baseline and up to ~38 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Change from baseline in Role functioning score of QLQ-C30 Items 6-7 Baseline and up to ~38 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.
Trial Locations
- Locations (106)
Sheba Medical Center ( Site 2200)
🇮🇱Ramat Gan, Israel
Oslo universitetssykehus, Radiumhospitalet ( Site 2400)
🇳🇴Oslo, Norway
Sigmedical Services SRL ( Site 2603)
🇷🇴Suceava, Romania
klinikum rechts der isar der technischen universität münchen ( Site 2009)
🇩🇪München, Bayern, Germany
USC/Norris Comprehensive Cancer Center ( Site 1112)
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian ( Site 1122)
🇺🇸Newport Beach, California, United States
Stanford Cancer Center ( Site 1109)
🇺🇸Palo Alto, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 1103)
🇺🇸Sacramento, California, United States
Winship Cancer Institute, Emory University ( Site 1151)
🇺🇸Atlanta, Georgia, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1118)
🇺🇸Iowa City, Iowa, United States
University of Kentucky Chandler Medical Center ( Site 1101)
🇺🇸Lexington, Kentucky, United States
Ochsner Clinic Foundation ( Site 1113)
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital ( Site 1162)
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute ( Site 1130)
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine-Internal Medicine/Oncology ( Site 1100)
🇺🇸Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1125)
🇺🇸Hackensack, New Jersey, United States
Atlantic Health System Morristown Medical Center ( Site 1136)
🇺🇸Morristown, New Jersey, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1160)
🇺🇸Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 1121)
🇺🇸New York, New York, United States
Providence Portland Medical Center ( Site 1102)
🇺🇸Portland, Oregon, United States
UPMC Hillman Cancer Center ( Site 1107)
🇺🇸Pittsburgh, Pennsylvania, United States
Avera Cancer Institute- Research ( Site 1161)
🇺🇸Sioux Falls, South Dakota, United States
University of Virginia Health System ( Site 1115)
🇺🇸Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 1108)
🇺🇸Fairfax, Virginia, United States
University Hospital and UW Health Clinics ( Site 1119)
🇺🇸Madison, Wisconsin, United States
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1213)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 1205)
🇦🇷Rosario, Santa Fe, Argentina
Sanatorio Finochietto ( Site 1202)
🇦🇷Buenos Aires, Argentina
Investigaciones Clinicas Moleculares (ICM) ( Site 1212)
🇦🇷Caba, Argentina
Hospital Italiano de Córdoba ( Site 1204)
🇦🇷Cordoba, Argentina
Melanoma Institute Australia-Clinical Trials Unit ( Site 3205)
🇦🇺Wollstonecraft, New South Wales, Australia
Sunshine Coast University Hospital-Medical Oncology ( Site 3212)
🇦🇺Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
🇦🇺Brisbane, Queensland, Australia
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 3207)
🇦🇺Gold Coast, Queensland, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 3206)
🇦🇺Greenslopes, Queensland, Australia
Austin Health ( Site 3209)
🇦🇺Heidelberg, Victoria, Australia
Instituto Tumori Giovanni Paolo II ( Site 2301)
🇮🇹Bari, Puglia, Italy
One Clinical Research ( Site 3211)
🇦🇺Nedlands, Western Australia, Australia
Cliniques universitaires Saint-Luc ( Site 1701)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
UZ Gent-Medical oncology ( Site 1702)
🇧🇪Gent, Oost-Vlaanderen, Belgium
Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315)
🇧🇷Salvador, Bahia, Brazil
Hospital de Cancer de Londrina-Clinical Research Unit ( Site 1316)
🇧🇷Londrina, Parana, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 1309)
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1300)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 1312)
🇧🇷Lages, Santa Catarina, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
🇧🇷São José do Rio Preto, Sao Paulo, Brazil
IPITEC ( Site 1313)
🇧🇷São Paulo, Sao Paulo, Brazil
Jewish General Hospital ( Site 1009)
🇨🇦Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
🇨🇦Sherbrooke, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 1411)
🇨🇱Temuco, Araucania, Chile
CIDO SpA-Oncology ( Site 1405)
🇨🇱Temuco, Araucania, Chile
FALP-UIDO ( Site 1401)
🇨🇱Santiago, Region M. De Santiago, Chile
Clínica Alemana de Santiago-Gynecology and Obstetrics ( Site 1410)
🇨🇱Santiago, Region M. De Santiago, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1501)
🇨🇴Medellín, Antioquia, Colombia
Oncologos del Occidente ( Site 1504)
🇨🇴Pereira, Risaralda, Colombia
Fundación Valle del Lili ( Site 1502)
🇨🇴Cali, Valle Del Cauca, Colombia
Vseobecna fakultni nemocnice v Praze-Department of Dermatology ( Site 1800)
🇨🇿Prague, Praha 2, Czechia
CHU de Bordeaux Hop St ANDRE ( Site 1902)
🇫🇷Bordeaux, Aquitaine, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1903)
🇫🇷Marseille, Bouches-du-Rhone, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1904)
🇫🇷Dijon, Bourgogne, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 1908)
🇫🇷Toulouse, Haute-Garonne, France
Gustave Roussy ( Site 1909)
🇫🇷Villejuif, Ile-de-France, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 1910)
🇫🇷Nantes, Loire-Atlantique, France
Hopital Claude Huriez - CHU de Lille ( Site 1907)
🇫🇷Lille, Nord, France
centre hospitalier lyon sud ( Site 1901)
🇫🇷Pierre-Bénite, Rhone, France
Hôpital Saint-Louis ( Site 1906)
🇫🇷Paris, France
NCT ( Site 2002)
🇩🇪Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen-Hautklinik ( Site 2003)
🇩🇪Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 2001)
🇩🇪Wuerzburg, Bayern, Germany
Klinikum Dortmund Klinikzentrum Mitte ( Site 2008)
🇩🇪Dortmund, Nordrhein-Westfalen, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 2005)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 2007)
🇩🇪Mainz, Rheinland-Pfalz, Germany
Universitätsklinikum Schleswig-Holstein-Dermatology ( Site 2012)
🇩🇪Lubeck, Schleswig-Holstein, Germany
Pécsi Tudományegyetem Klinikai Központ-Bőr-, Nemikórtani és Onkodermatológiai Klinika ( Site 2100)
🇭🇺Pecs, Baranya, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Közpo-Department of Dermatology and Allergol
🇭🇺Szeged, Csongrad, Hungary
Debreceni Egyetem Klinikai Kozpont-Bőrgyógyászati Klinika ( Site 2102)
🇭🇺Debrecen, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz- Onkoradiologiai Osztaly ( Site 2110)
🇭🇺Gyor, Hungary
Emek Medical Center ( Site 2203)
🇮🇱Afula, Israel
Hadassah Medical Center ( Site 2201)
🇮🇱Jerusalem, Israel
Rabin Medical Center ( Site 2202)
🇮🇱Petah Tikva, Israel
Ospedale San Martino-Oncologia Medica 2 ( Site 2303)
🇮🇹Genova, Liguria, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2304)
🇮🇹Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Senese ( Site 2302)
🇮🇹Siena, Toscana, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 2305)
🇮🇹Bergamo, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
🇮🇹Napoli, Italy
Harbour Cancer & Wellness ( Site 3300)
🇳🇿Auckland, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2501)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2506)
🇵🇱Gdansk, Pomorskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
🇵🇱Kielce, Swietokrzyskie, Poland
Centrum Medyczne HCP ( Site 2505)
🇵🇱Poznań, Wielkopolskie, Poland
Spitalul Universitar de Urgență Elias ( Site 2600)
🇷🇴București, Bucuresti, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2602)
🇷🇴Florești, Cluj, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2601)
🇷🇴Craiova, Dolj, Romania
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 2804)
🇪🇸Badalona, Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
🇪🇸Barcelona, Cataluna, Spain
Centro Oncologico de Galicia ( Site 2806)
🇪🇸A Coruna, Galicia, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2801)
🇪🇸Madrid, Madrid, Comunidad De, Spain
H.R.U Malaga - Hospital General ( Site 2805)
🇪🇸Málaga, Malaga, Spain
Hospital General Universitario de Valencia-oncology service ( Site 2802)
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2803)
🇪🇸Barcelona, Spain
Clinica Universidad de Navarra-Medical Oncology ( Site 2807)
🇪🇸Madrid, Spain
Addenbrooke's Hospital-Cambridge Cancer Trials Centre ( Site 3103)
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Derriford Hospital-Oncology ( Site 3104)
🇬🇧Plymouth, Devon, United Kingdom
Castle Hill Hospital ( Site 3102)
🇬🇧Cottingham, East Riding Of Yorkshire, United Kingdom
Singleton Hospital-South West Wales Cancer Institute ( Site 3100)
🇬🇧Swansea, United Kingdom