Hauttumorzentrum der Universitäts-Hautklinik und des NCT Heidelberg Im Neuenheimer Feld 460 69120 Heidelberg (Baden-Württemberg) DeutschlandNoch nicht rekrutierend» Google-Maps Ansprechpartner: Jessica Hassel, Prof. Dr. med E-Mail: Studien-DermaOnko.NCT@med.uni-heidelberg.de» Ansprechpartner anzeigenUniversitätsklinikum Essen (AöR) 45147 Essen (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Halime Kalkavan, Dr. med Phone: +49 201 72384150 E-Mail: halime.kalkavan@uk-essen.de» Ansprechpartner anzeigenUniversitätsklinikum Köln 50937 Köln (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Nicole Kreuzberg, MD E-Mail: halime.kalkavan@uk-essen.de» Ansprechpartner anzeigen
Universitätsklinikum Carl Gustav Carus Dresden 1307 Dresden (Sachsen) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Friedegund Meier, Prof. Dr. med Phone: +49 (0) 351 458 19782 E-Mail: oncostudien.dermatologie@ukdd.de» Ansprechpartner anzeigenCharité - Universitätsmedizin Berlin 12203 Berlin (Berlin) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Caroline Anna Peuker, MD Phone: +49 30 450 513470 E-Mail: caroline-anna.peuker@charite.de» Ansprechpartner anzeigenHonor Health 85258 Scottsdale United StatesRekrutierend» Google-Maps Ansprechpartner: Oncology Clinical Trials Nurse Navigator Phone: 480-323-1791 E-Mail: clinicaltrials@honorhealth.com
Phone: 833-354-6667» Ansprechpartner anzeigenMoores Cancer Center 92093 La Jolla United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Katie O'Neil, BA Phone: 858-822-5354 E-Mail: croneil@health.ucsd.edu
Jazelle Molina Phone: 858-822-5354 E-Mail: jgmolina@health.ucsd.edu» Ansprechpartner anzeigenUCLA Medical Center 90024 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Adyel Annelus Phone: 310-794-4955 E-Mail: aannelus@mednet.ucla.edu
Elizabeth Seja Phone: 310-794-6892 E-Mail: eseja@mednet.ucla.edu» Ansprechpartner anzeigenThe Angeles Clinic and Research Institute 90025 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Saba Mukarram Phone: 310-231-2181 E-Mail: smukarram@theangelesclinic.org» Ansprechpartner anzeigenCalifornia Pacific Medical Center (CPMC) 94115 San Francisco United StatesRekrutierend» Google-Maps Ansprechpartner: Denise Fortun Phone: 415-600-1775 E-Mail: denise.fortun@sutterhealth.org
CPMC Clinical Research Group E-Mail: clinicalresearch@sutterhealth.org» Ansprechpartner anzeigenUniversity of California San Francisco 94143 San Francisco United StatesRekrutierend» Google-Maps Ansprechpartner: Sonia Contreras Martinez, BSN Phone: 415-514-6427 E-Mail: sonia.contrerasmartinez@ucsf.edu» Ansprechpartner anzeigenUniversity of Colorado Cancer Center 80045 Aurora United StatesNoch nicht rekrutierend» Google-MapsSCRI at HealthONE 80218 Denver United StatesRekrutierend» Google-Maps Ansprechpartner: SCRI Front Desk Phone: 720-754-2610 E-Mail: cann.ddudenvergeneral@sarahcannon.com» Ansprechpartner anzeigenUniversity of Miami Sylvester Comprehensive Cancer Center 33136 Miami United StatesRekrutierend» Google-Maps Ansprechpartner:
E-Mail: CRSCutaneous@miami.edu» Ansprechpartner anzeigenMoffitt Cancer Center 33612 Tampa United StatesNoch nicht rekrutierend» Google-MapsNorthside Hospital Atlanta 30342 Atlanta United StatesRekrutierend» Google-Maps Ansprechpartner: Central Research Department Phone: 404-303-3355 E-Mail: clinicaltrials@northside.com» Ansprechpartner anzeigenUniversity of Iowa 52242 Iowa City United StatesRekrutierend» Google-Maps Ansprechpartner: Asad Javed, MD Phone: 319-467-5156 E-Mail: asad-javed@uiowa.edu» Ansprechpartner anzeigenMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Kamaneh Montazeri, MD Phone: 617-724-4000 E-Mail: kmontazeri@mgh.harvard.edu» Ansprechpartner anzeigenDana Farber Cancer Institute 02215 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Rizwan Haq Phone: 617-632-6168 E-Mail: rizwan_haq@dfci.harvard.edu
Linnea Drew Phone: 617-632-6705 E-Mail: linneam_drew@dfci.harvard.edu» Ansprechpartner anzeigenThe Cancer and Hematology Centers 49546 Grand Rapids United StatesRekrutierend» Google-Maps Ansprechpartner: The Cancer and Hematology Centers Phone: 616-954-5550 E-Mail: ClinicalTrials@chcwm.com
Jessica Miller, RN Phone: 616-954-5550 Phone (ext.): 1651 E-Mail: Jmiller@chcwm.com» Ansprechpartner anzeigenMayo Clinic 55905 Rochester United StatesNoch nicht rekrutierend» Google-MapsWashington University School of Medicine 63110 Saint Louis United StatesNoch nicht rekrutierend» Google-MapsRoswell Park Cancer Institute 14263 Buffalo United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Benjamin Switzer, DO Phone: 716-845-7668 E-Mail: benjamin.switzer@rosewellpark.org
igor Puzanov, MD Phone: 716-845-7505 E-Mail: igor.puzanov@roswellpark.org» Ansprechpartner anzeigenNorthwell Health 11030 Manhasset United StatesRekrutierend» Google-Maps Ansprechpartner: Richard Carvajal, MD E-Mail: rcarvajal2@northwell.edu
Tracy Green, BS E-Mail: tgreen22@northwell.edu» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center 10065 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Alexander Shoushtari, MD Phone: 646-888-4161 E-Mail: shoushta@mskcc.org
James Smithy, MD Phone: 929-623-0275 E-Mail: smithyj@mskcc.org» Ansprechpartner anzeigenDuke University Health System 27710 Durham United StatesRekrutierend» Google-Maps Ansprechpartner: Carol Ann Wiggs, BSN Phone: 919-684-0281 E-Mail: carolann.wiggs@duke.edu
Emily Bolch Phone: 919-668-6359 E-Mail: emily.bolch@duke.edu» Ansprechpartner anzeigenUniversity of Cincinnati 45267 Cincinnati United StatesRekrutierend» Google-Maps Ansprechpartner:
Phone: 513-584-7698 E-Mail: cancer@uchealth.com» Ansprechpartner anzeigenThe Cleveland Clinic Foundation 44195 Cleveland United StatesRekrutierend» Google-Maps Ansprechpartner: Lucy Kennedy, MD Phone: 216-317-5561 E-Mail: KENNEDL5@ccf.org» Ansprechpartner anzeigenThomas Jefferson University 19107 Philadelphia United StatesRekrutierend» Google-Maps Ansprechpartner: Marlana Orloff Phone: 215-955-9980 E-Mail: Marlana.Orloff@Jefferson.edu
Kristie Hensel Phone: 215-955-9980 E-Mail: Kristie.Hensel@Jefferson.edu» Ansprechpartner anzeigenUniversity of Pittsburgh Medical Center 15232 Pittsburgh United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Amy Rose, RN,BSN Phone: 412-647-8587 E-Mail: kennaj@upmc.edu
Jennifer Cleric, ND, RN Phone: 412-864-7893 E-Mail: clericja@upmc.edu» Ansprechpartner anzeigenSCRI- Tennessee Oncology 37203 Nashville United StatesRekrutierend» Google-Maps Ansprechpartner: SCRI Front Desk Phone: 844-482-4812» Ansprechpartner anzeigenUT Southwestern Medical Center 75390 Dallas United StatesRekrutierend» Google-Maps Ansprechpartner: Sanjay Chandrasekaran, MD Phone: 833-722-6237 E-Mail: sanjay.chandrasekaran@utsouthwestern.edu
Desiree Pierre, BS Phone: 214-648-3111 E-Mail: desiree.pierre@utsouthwestern.edu» Ansprechpartner anzeigenHouston Methodist Cancer Center 77030 Houston United StatesNoch nicht rekrutierend» Google-MapsMD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-Maps Ansprechpartner: Sapna Patel, MD Phone: 713-792-2921 E-Mail: sppatel@mdanderson.org» Ansprechpartner anzeigenWestmead Hospital 2145 Sydney AustraliaRekrutierend» Google-Maps Ansprechpartner: Matteo Carlino, MD Phone: +61 288 905 200 E-Mail: matteo.carlino@sydney.edu.au» Ansprechpartner anzeigenPrincess Alexander Hospital 4102 Brisbane AustraliaRekrutierend» Google-Maps Ansprechpartner: Janine Thomas Phone: +61(0)731767578 E-Mail: janine.thomas@health.qld.gov.au» Ansprechpartner anzeigenAlfred Health 3168 Melbourne AustraliaRekrutierend» Google-MapsSir Charles Gairdner Hospital 6009 Perth AustraliaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Joanne Tonkin Phone: 0863833185 E-Mail: SCGH.MedOncCTM@health.wa.gov.au
Rose McDowell Phone: 0863833190 E-Mail: Rose.McDowell@health.wa.gov.au» Ansprechpartner anzeigenQueen Elizabeth Hospital Adelaide AustraliaNoch nicht rekrutierend» Google-MapsCliniques Universitaires Saint Luc 1200 Brussels BelgiumNoch nicht rekrutierend» Google-Maps Ansprechpartner: Jean Francois Baurain, MD E-Mail: jean-francois.baurain@saintluc.uclouvain.be» Ansprechpartner anzeigenCross Cancer Institute, University of Alberta T6G 1Z2 Edmonton CanadaNoch nicht rekrutierend» Google-Maps Ansprechpartner: John Walker, MD,PhD,FRCPC Phone: 780-577-8082 E-Mail: john.walker2@ahs.ca» Ansprechpartner anzeigenPrincess Margaret Cancer Centre M5G 2M9 Toronto CanadaRekrutierend» Google-Maps Ansprechpartner: Marcus Butler Phone: 416-946-4501 Phone (ext.): 5485 E-Mail: marcus.butler@uhn.ca» Ansprechpartner anzeigenCentre Hospitalier de l'Universite de Montreal- CHUM H2X 0C1 Montréal CanadaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Rahima Jamal, MD Phone: 514-890-8444 E-Mail: rahima.jamal.med@ssss.gouv.qc.ca
Chantal Gosselin Phone: 514-890-8000 Phone (ext.): 24892 E-Mail: urcoh.eligibilite.chum@ssss.gouv.qc.ca» Ansprechpartner anzeigenThe Leon Berard Center Lyon FranceNoch nicht rekrutierend» Google-Maps Ansprechpartner: Eve-Marie Neidhardt, MD E-Mail: evemarie.neidhardt@lyon.unicancer.fr» Ansprechpartner anzeigenInstitut Curie 75005 Paris FranceNoch nicht rekrutierend» Google-Maps Ansprechpartner: Sophie Piperno-Neumann, MD Phone: +33 0 1 44 32 40 68 E-Mail: sophie.piperno-neumann@curie.fr» Ansprechpartner anzeigenHadassah Medical Center 91120 Jerusalem IsraelRekrutierend» Google-Maps Ansprechpartner: Jonathan Cohen, MD Phone: 972 50 5172537 E-Mail: cohenjon@hadassah.org.il
Annaelle Dynovisz, SC Phone: 972-58-4820222 E-Mail: annaelled@hadassah.org.il» Ansprechpartner anzeigenSheba Medical Center 52621 Ramat-Gan IsraelRekrutierend» Google-Maps Ansprechpartner: Ronnie Shapira, MD Phone: 972 3-5302243 E-Mail: ronnie.shapira@sheba.health.gov.il» Ansprechpartner anzeigenFondazione IRCCS Istituto Nazionale dei Tumori 20133 Milano ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Lorenza DiGuardo, MD Phone: 0039 02 23905000 E-Mail: Lorenza.DiGuardo@istitutotumori.mi.it» Ansprechpartner anzeigenIstituto Nazionale dei Tumori Fondazione Pascale 80131 Napoli ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Paolo Ascierto, MD Phone: +39 081 17770810 E-Mail: melanoma.immunoterapia@istitutotumori.na.it» Ansprechpartner anzeigenFondazione Policlinico Gemelli IRCCS 00168 Roma ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Ernesto Rossi, MD Phone: +39 06 30156318 E-Mail: ernesto.rossi@policlinicogemelli.it» Ansprechpartner anzeigenAOUS Policlinico Le Scotte 53100 Siena ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Michele Maio, MD Phone: +39 0577586304 E-Mail: dh.immunonco@ao-siena.toscana.it» Ansprechpartner anzeigenLUMC (Leids Universitair Medisch Centrum) 2333 ZA Leiden NetherlandsNoch nicht rekrutierend» Google-Maps Ansprechpartner: Ellen Kapiteijn, MD Phone: +31 (0)71 526 1093 E-Mail: h.w.kapiteijn@lumc.nl» Ansprechpartner anzeigenOśrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne w Gdańsku 80-214 Gdańsk PolandNoch nicht rekrutierend» Google-Maps Ansprechpartner:
Phone: +48 58 584 44 66 E-Mail: obkwf@uck.gda.pl» Ansprechpartner anzeigenNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy 02-781 Warsaw PolandNoch nicht rekrutierend» Google-Maps Ansprechpartner:
Phone: +48 22 546 21 03 E-Mail: badaniakliniczne@pib-nio.pl» Ansprechpartner anzeigenCatalan Institute of Oncology 8908 L'Hospitalet de Llobregat SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: Josep Maria Piulats, MD Phone: +34 932607744 E-Mail: contactfortrialsICOLH@iconcologia.net» Ansprechpartner anzeigenHospital Universitario La Paz 28046 Madrid SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: Yolanda Alvarez, BSc E-Mail: yolandalapaz@gmail.com» Ansprechpartner anzeigenHospital Clínico Universitario de Santiago de Compostela 15706 Santiago de Compostela SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: Estiban Mendez, Bsc Phone: +34 663 609 134 E-Mail: estiban.mendez.barrio@sergas.es» Ansprechpartner anzeigenHospital Universitario Virgen Macarena 41009 Sevilla SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: María del Carmen Álamo, MD Phone: +34 629 310 196 (611565) E-Mail: alamodelagala@gmail.com
María Candón, SC Phone: +34 629 310 196 (611565) E-Mail: mariacandon.oncomacarena@gmail.com» Ansprechpartner anzeigenHospital General Universitario Valencia 46014 Valencia SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: Alfonso Berrocal, MD Phone: +34 96 313 18 00 Phone (ext.): 437635 E-Mail: berrocal.alf@gmail.com
Iris Ramos Phone: +34 96 313 18 00 Phone (ext.): 437635 E-Mail: ramos_iri@gva.es» Ansprechpartner anzeigenDermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung 8058 Zuerich SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Reinhard Dummer, Prof. Dr. med Phone: 0041 44 255 25 88 E-Mail: reinhard.dummer@usz.ch» Ansprechpartner anzeigenThe Beatson West of Scotland Cancer Centre G12 0YN Glasgow United KingdomNoch nicht rekrutierend» Google-Maps Ansprechpartner: Ruth Orr Phone: 00 44 (0) 141 301 7207 E-Mail: ruth.orr@glasgow.ac.uk» Ansprechpartner anzeigenMount Vernon Cancer Centre East & North Herts NHS Trust HA6 2RN Northwood United KingdomNoch nicht rekrutierend» Google-MapsThe Clatterbridge Cancer Centre NHS Foundation Trust CH63 4JY Wirral United KingdomNoch nicht rekrutierend» Google-Maps Ansprechpartner: Joseph Sacco, Professor Phone: 0151 556 5000 E-Mail: joseph.sacco@nhs.net» Ansprechpartner anzeigen
1. Progression-Free Survival (PFS) by blinded independent central review (BICR) of IDE196 + Crizotinib compared to investigator's choice of treatment (Time Frame - Approximately 2 years): PFS per RECIST 1.1
2. Overall Survival (OS) of IDE196 + Crizotinib compared to investigator's choice of treatment (Time Frame - Approximately 4 years): OS from randomization to date of death due to any cause
Secondary outcome:
1. Safety of IDE196 + Crizotinib: Incidence of Adverse Events (Time Frame - Approximately 2 years): Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs as measured by CTCAE V5.0
2. Phase 2a: Dose exposure response of IDE196 (Time Frame - Approximately 5 months): Dose-exposure-response of IDE196 as measured by concentration of IDE196 in plasma
3. Phase 2a: Dose exposure response of Crizotinib (Time Frame - Approximately 5 months): Dose-exposure-response of Crizotinib as measured by concentration of Crizotinib in plasma
4. Progression-Free Survival (PFS) per Investigator of IDE196 + Crizotinib compared to investigator's choice of treatment (Time Frame - Approximately 2 years): PFS per RECIST 1.1
5. Objective Response Rate (ORR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment (Time Frame - Approximately 2 years): ORR per RECIST 1.1
6. Duration of Response (DOR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment (Time Frame - Approximately 2 years): DOR per RECIST 1.1
7. Change from baseline over time and between treatment arms in EORTC QLQ-C30 (Time Frame - Approximately 2 years): Global health status and quality of life will be assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.
8. Change from baseline over time and between treatment arms in EuroQoL (EQ)-5D-5L scores (Time Frame - Approximately 2 years): General health status will be assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.
Experimental: Phase 2a Dose Optimization of IDE196 + crizotinib Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.
Experimental: Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.
Active Comparator: Phase 2a / 2b / 3 Comparator Arm Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.
