summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

ReferenceCitation: van der Heijden MS, Loriot Y, Duran I, Ravaud A, Retz M, Vogelzang NJ, Nelson B, Wang J, Shen X, Powles T. Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial. Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Powles T, Duran I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, Flechon A, Gravis G, Hussain S, Takano T, Leng N, Kadel EE 3rd, Banchereau R, Hegde PS, Mariathasan S, Cui N, Shen X, Derleth CL, Green MC, Ravaud A. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748-757. doi: 10.1016/S0140-6736(17)33297-X. Epub 2017 Dec 18. Erratum In: Lancet. 2018 Oct 20;392(10156):1402.

repository_institution: University of Plymouth - PEARL

ReferenceCitation: Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8. Erratum In: Lancet. 2017 Aug 26;390(10097):848.

repositories_concat: PubMed Central;www.repositoriosalud.es

ReferenceCitation: Kim YS, Lee SI, Park SH, Park S, Hwang IG, Lee SC, Sun JM, Lee J, Lim HY. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):76-81. doi: 10.1016/j.clgc.2015.09.008. Epub 2015 Sep 25.

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

location_facility: Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Royal Brisbane and Women's Hospital; Medical Oncology

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

location_facility: Emory University; Winship Cancer Institute

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Hiroshima City Hiroshima Citizens Hospital; Urology

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: National Cancer Center Hospital; Urology

location_facility: National Hospital Organization Shikoku Cancer Center; Urology

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Maastricht University Medical Centre; Medical Oncology

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: National Cancer Center Hospital East; Breast and Medical Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hirosaki University School of Medicine & Hospital; Urology

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Scunthorpe General Hospital; Dept of Oncology

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Hospital of Patras Medical Oncology

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Uniklinik RWTH Aachen; Klinik für Urologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Medical University of Bialystok; Oncology clinic

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie

location_facility: Osaka International Cancer Institute; Urology

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Uni Hospital of Tromso; Dept. of Oncology

location_facility: China Medical University Hospital; Urology

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Turku University Central Hospital; Urology clinic

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Istanbul VKV American Hospital; Medical Oncology

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Iwate Medical University Hospital; Urology

location_facility: University Hospital coventry; Oncology Department

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Sapporo Medical University Hospital; Urology

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Yokohama City University Hospital; Urology

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

location_facility: Institute Of Oncology Bucharest; Medical Oncology

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Spitalul Judetean de Urgenta Dr Constantin Opris

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Northern Centre for Cancer Care; Northern Centre for Cancer Care

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Hopital Hautepierre; Hematologie Oncologie

title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy

location_country:
Finland
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
Serbia
France
Slovenia
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


type: EudraCT Number

title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]

summary: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Imperial College London - Spiral

repository_institution: University of Dundee - Discovery Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_institution: University of Dundee - Discovery Research Portal

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: hybrid

ReferenceCitation: Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Calverley PMA, Anzueto AR, Carter K, Gronke L, Hallmann C, Jenkins C, Wedzicha J, Rabe KF. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med. 2018 May;6(5):337-344. doi: 10.1016/S2213-2600(18)30102-4. Epub 2018 Apr 5.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
Malaysia
Philippines
Italy
Guatemala
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden

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intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study

acronym: BREACH

summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.

ReferenceCitation: Fornecker LM, Lazarovici J, Aurer I, Casasnovas RO, Gac AC, Bonnet C, Bouabdallah K, Feugier P, Specht L, Molina L, Touati M, Borel C, Stamatoullas A, Nicolas-Virelizier E, Pascal L, Lugtenburg P, Di Renzo N, Vander Borght T, Traverse-Glehen A, Dartigues P, Hutchings M, Versari A, Meignan M, Federico M, Andre M; LYSA-FIL-EORTC Intergroup. Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial. J Clin Oncol. 2023 Jan 10;41(2):327-335. doi: 10.1200/JCO.21.01281. Epub 2022 Jul 22.

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Denmark Netherlands Belgium Croatia France

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Radboud University Medical Center Nijmegen


title: Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study

acronym: OSCA

summary: This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

study_type: Observational

time_perspective: Retrospective

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
RTI Health Solutions
A+A Healthcare Marketing Research
Freelance CRA (FCRA)

location_country:
Germany
Italy
Portugal
Israel
United Kingdom
Australia
Netherlands
Switzerland
Belgium
Korea, Republic of
Spain
Canada
France

intervention_type: Other


type: Other Identifier

title: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

summary: The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Mateos MV, Rigaudeau S, Basu S, Spicka I, Schots R, Wrobel T, Cook G, Beksac M, Gries KS, Kudva A, Tromp B, Van Rampelbergh R, Pei H, Wroblewski S, Carson R, Delioukina M, White D. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma. J Oncol Pharm Pract. 2023 Jul;29(5):1172-1177. doi: 10.1177/10781552221103551. Epub 2022 Sep 6.

oa_host_type: closed

publisher_dissemination: SAGE Publications

ReferenceCitation: Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

ReferenceCitation: Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

evidence: open (via free article)

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ReferenceCitation: San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.

evidence: open (via page says license)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
sdu.dk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;sdu.dk

ReferenceCitation: Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.

repository_institution: University of Wolverhampton - Wolverhampton Intellectual Repository and E-Theses

location_country:
Germany
Ireland
Israel
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United States
Canada
France


title: A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics

summary: To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.

time_perspective: Prospective

location_country:
Germany
Italy
United Kingdom
United States
France


title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer

summary: The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.

ReferenceCitation: Verry C, Vincendeau S, Massetti M, Blachier M, Vimont A, Bazil ML, Bernardini P, Pettre S, Timsit MO. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022 Jul;17(4):441-451. doi: 10.1007/s11523-022-00899-6. Epub 2022 Jul 16.

repositories_concat: PubMed Central

ReferenceCitation: Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.

repository_institution: PubMed Central - Europe PMC

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Lisbon - Repositório da Universidade de Lisboa

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Germany
France
Poland
Slovenia
Portugal
United Kingdom
Sweden
Switzerland
Austria
Belgium
Spain
Luxembourg
Turkey
Russian Federation
Israel


title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma

summary: The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

ReferenceCitation: Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repositories_concat: PubMed Central;cris.unibo.it

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

location_country:
Italy
Poland
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
Czechia
France

status_simplified: Ongoing


title: A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

sponsor_collaborators:
AstraZeneca
PRA Health Sciences

location_country:
Germany
Hungary
Israel
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Czechia
Canada
Georgia
France