Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II 20246 Hamburg (Hamburg) GermanyRekrutierend» Google-MapsMedizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie 30625 Hannover (Niedersachsen) GermanyRekrutierend» Google-MapsSLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm. 74078 Heilbronn (Baden-Württemberg) GermanyRekrutierend» Google-MapsPraxis für Hämatologie, Onkologie und Palliativmedizin 41066 Mönchengladbach (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsKlinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III 81377 München (Bayern) GermanyRekrutierend» Google-MapsUniverstitätsklinikum Ulm; Klinik für Innere Medizin III 89081 Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU 97078 Würzburg (Bayern) GermanyRekrutierend» Google-MapsSouthern Cancer Center 36526 Daphne United StatesZurückgezogen» Google-MapsWestern Regional Medical Center at Cancer Treatment Centers of America 85338 Goodyear United StatesRekrutierend» Google-MapsCity of Hope National Medical Center 91010 Duarte United StatesAbgeschlossen» Google-MapsKaiser Permanente Los Angeles; Clinic/Infusion -LA 90027 Los Angeles United StatesAktiv, nicht rekrutierend» Google-MapsUSC Norris Cancer Center 90033 Los Angeles United StatesRekrutierend» Google-MapsHoag Memorial Hospital 92658 Newport Beach United StatesAbgeschlossen» Google-MapsUC Davis Comprehensive Cancer Center 95817 Sacramento United StatesAbgebrochen» Google-MapsUniversity of California at San Francisco 94115 San Francisco United StatesAbgeschlossen» Google-MapsSarcoma Oncology Center 90403 Santa Monica United StatesRekrutierend» Google-MapsChildren's Hospital Colorado; Center For Cancer/Blood Disorder 80045 Aurora United StatesRekrutierend» Google-MapsChristiana Care Health Srvcs; Helen F Graham Can Center 19713 Newark United StatesAbgeschlossen» Google-MapsUniversity of Florida 32607 Gainesville United StatesZurückgezogen» Google-MapsMiami Cancer Institute of Baptist Health, Inc. 33176 Miami United StatesRekrutierend» Google-MapsOcala Oncology Center 34471 Ocala United StatesRekrutierend» Google-MapsUniversity Cancer & Blood Center, LLC; Research 30607 Athens United StatesRekrutierend» Google-MapsSt. Alphonsus 83706 Boise United StatesRekrutierend» Google-MapsMidwestern Regional Med Center 60099 Zion United StatesAktiv, nicht rekrutierend» Google-MapsHorizon Oncology Research, Inc. 47905 Lafayette United StatesAbgeschlossen» Google-MapsNew England Cancer Specialists 04074 Scarborough United StatesZurückgezogen» Google-MapsMaryland Hematology & Oncology. P.A. 20904 Silver Spring United StatesRekrutierend» Google-MapsSt. Joseph Mercy Hospital 48106 Ann Arbor United StatesRekrutierend» Google-MapsHenry Ford Health System 48202 Detroit United StatesRekrutierend» Google-MapsUniversity of Minnesota 55455 Minneapolis United StatesZurückgezogen» Google-MapsMetro-Minnesota Community Oncology Research Consortium 55416 Saint Louis Park United StatesRekrutierend» Google-MapsWashington University 63128 Saint Louis United StatesZurückgezogen» Google-MapsSt. Vincent Frontier Cancer Center 59102 Billings United StatesRekrutierend» Google-MapsNebraska Methodist Hospital; Cancer Center 68114 Omaha United StatesRekrutierend» Google-MapsComprehensive Cancer Centers of Nevada - Eastern Avenue 89169 Las Vegas United StatesZurückgezogen» Google-MapsDartmouth Hitchcock Medical Center 03756 Lebanon United StatesRekrutierend» Google-MapsRutgers Cancer Institute of New Jersey 08901 New Brunswick United StatesRekrutierend» Google-MapsUniversity of New Mexico; Comprehensive Cancer Center 87131 Albuquerque United StatesRekrutierend» Google-MapsMontefiore Einstein Center for Cancer Care 10461 Bronx United StatesRekrutierend» Google-MapsEastchester Center for Cancer Care 10469 Bronx United StatesZurückgezogen» Google-MapsNew York Cancer and Blood Specialists - Setauket Medical Oncology 11733 East Setauket United StatesZurückgezogen» Google-MapsNational Translational Research Group 10028 New York United StatesZurückgezogen» Google-MapsIcahn School of Medicine at Mount Sinai 10029 New York United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 11101 New York United StatesAbgebrochen» Google-MapsLevine Cancer Institute 28204 Charlotte United StatesZurückgezogen» Google-MapsBarrett Cancer Center 45219 Cincinnati United StatesAbgeschlossen» Google-MapsOncology Hematology Care Inc 45242 Cincinnati United StatesRekrutierend» Google-MapsProvidence Portland Medical Center 97213 Portland United StatesAbgeschlossen» Google-MapsConsultants in Medical Oncology and Hematology 19008 Broomall United StatesRekrutierend» Google-MapsAlliance Cancer Specialists 19044 Horsham United StatesRekrutierend» Google-MapsThe Children's Hospital of Philadelphia 19104 Philadelphia United StatesRekrutierend» Google-MapsCancer Treatment Centers of America; Eastern Regional Medical Center 19124 Philadelphia United StatesAbgeschlossen» Google-MapsPRISMA Health - Greenville 29605 Greenville United StatesZurückgezogen» Google-MapsThe West Clinic; West Cancer Center 38138 Germantown United StatesRekrutierend» Google-MapsSt. Jude Children'S Research Hospital 38105 Memphis United StatesRekrutierend» Google-MapsTexas Onc-Central Austin CA Ct 78731 Austin United StatesRekrutierend» Google-MapsMary Crowley Medical Research Center 75230 Dallas United StatesRekrutierend» Google-MapsTexas Oncology - Baylor Charles A. Sammons Cancer Center 75246 Dallas United StatesAbgebrochen» Google-MapsCook Childrens Medical Center 76104 Fort Worth United StatesRekrutierend» Google-MapsThe University of Texas MD Anderson Cancer Center 77030-4009 Houston United StatesRekrutierend» Google-MapsTexas Oncology- Northeast Texas 75702 Tyler United StatesRekrutierend» Google-MapsVirginia Cancer Specialists - Leesburg 20176 Leesburg United StatesRekrutierend» Google-MapsNorthwest Medical Specialties, PLLC; Research Department 98405 Tacoma United StatesRekrutierend» Google-MapsFroedtert and The Medical College of Wisconsin 53226 Milwaukee United StatesRekrutierend» Google-MapsKinghorn Cancer Centre; St Vincents Hospital 2010 Darlinghurst AustraliaRekrutierend» Google-MapsSydney Children's Hospital 2031 Randwick AustraliaRekrutierend» Google-MapsRoyal Darwin Hospital; Alan Walker Cancer Centre 0810 Tiwi AustraliaRekrutierend» Google-MapsPrincess Alexandra Hospital 4102 Woolloongabba AustraliaRekrutierend» Google-MapsPeter MacCallum Cancer Centre; Medical Oncology 3000 Melbourne AustraliaAktiv, nicht rekrutierend» Google-MapsRoyal Children's Hospital 3052 Parkville AustraliaRekrutierend» Google-MapsCliniques Universitaires St-Luc 1200 Bruxelles BelgiumRekrutierend» Google-MapsGHdC Site Notre Dame 6000 Charleroi BelgiumRekrutierend» Google-MapsUZ Antwerpen 2650 Edegem BelgiumAktiv, nicht rekrutierend» Google-MapsUZ Gent 9000 Gent BelgiumRekrutierend» Google-MapsUZ Leuven Gasthuisberg 3000 Leuven BelgiumAktiv, nicht rekrutierend» Google-MapsHospital Moinhos de Vento 90035-000 Porto Alegre BrazilZurückgezogen» Google-MapsHospital Sírio-Libanês 01308-050 Sao Paulo BrazilZurückgezogen» Google-MapsHospital Sírio-Libanês 01308-050 Sao Paulo BrazilRekrutierend» Google-MapsHospital A. C. Camargo; Oncologia 01509-010 Sao Paulo BrazilRekrutierend» Google-MapsClínica Onco Star - Rede D'Or 04543-000 Sao Paulo BrazilRekrutierend» Google-MapsBC Cancer ? Vancouver V5Z 4E6 Vancouver CanadaRekrutierend» Google-MapsLondon Health Sciences Centre · Victoria Hospital; Department of Medicine N6A 5W9 London CanadaRekrutierend» Google-MapsThe Ottawa Hospital - General Campus K1H 8L6 Ottawa CanadaRekrutierend» Google-MapsThe Hospital for Sick Children M5G 1X8 Toronto CanadaRekrutierend» Google-MapsPrincess Margaret Cancer Center M5G 2M9 Toronto CanadaRekrutierend» Google-MapsMcGill University Health Center H4A 3J1 Montreal CanadaRekrutierend» Google-MapsBeijing Children's Hospital, Capital Medical University; Oncological Surgery Department 100032 Beijing City ChinaRekrutierend» Google-MapsBeijing Cancer Hospital 100142 Beijing ChinaRekrutierend» Google-MapsThe First Hospital of Jilin University 130021 Changchun City ChinaRekrutierend» Google-MapsJilin Cancer Hospital 132013 Changchun ChinaRekrutierend» Google-MapsWest China Hospital - Sichuan University 610047 Chengdu City ChinaRekrutierend» Google-MapsZhongshan Hospital Fudan Unvierstiy 200032 Shanghai City ChinaRekrutierend» Google-MapsXinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine 200092 Shanghai ChinaRekrutierend» Google-MapsShanghai East Hospital Shanghai ChinaAbgeschlossen» Google-MapsTianjin Cancer Hospital 300060 Tianjin ChinaRekrutierend» Google-MapsFirst Affiliated Hospital of Medical College of Xi'an Jiaotong University 710061 Xi'an ChinaRekrutierend» Google-MapsAarhus Universitetshospital; Kræftafdelingen 8200 Aarhus N DenmarkRekrutierend» Google-MapsRigshospitalet; Onkologisk Klinik 2100 København Ø DenmarkAktiv, nicht rekrutierend» Google-MapsInstitut Bergonie; Oncologie 33076 Bordeaux FranceRekrutierend» Google-MapsCentre Oscar Lambret; Service de Pediatrie 59020 Lille FranceAktiv, nicht rekrutierend» Google-MapsCENTRE LEON BERARD; Département d?Hématologie et d?Oncologie 69373 Lyon FranceAktiv, nicht rekrutierend» Google-MapsHopital de la Timone 13005 Marseille FranceAktiv, nicht rekrutierend» Google-MapsInstitut Universitaire du Cancer de Toulouse-Oncopole 31059 Toulouse FranceAktiv, nicht rekrutierend» Google-MapsInstitut de Cancerologie Gustave-Roussy (IGR) 94805 Villejuif FranceAktiv, nicht rekrutierend» Google-MapsHong Kong Children's Hospital Hong Kong Hong KongRekrutierend» Google-MapsPrince of Wales Hospital; Department of Clinical Onocology Shatin Hong KongRekrutierend» Google-MapsRambam Health Care Campus; Oncology 3109601 Haifa IsraelRekrutierend» Google-MapsHadassah University Hospital - Ein Kerem 9112001 Jerusalem IsraelRekrutierend» Google-MapsRabin MC; Davidof Center - Oncology Institute 4941492 Petach Tikva IsraelRekrutierend» Google-MapsSheba Medical Center 5262100 Ramat Gan IsraelAktiv, nicht rekrutierend» Google-MapsSourasky / Ichilov Hospital; Dept. of Oncology 6423906 Tel Aviv IsraelRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione G. Pascale 80131 Napoli ItalyRekrutierend» Google-MapsOspedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica 00165 Roma ItalyRekrutierend» Google-MapsPoliclinico Universitario Agostino Gemelli IRCCS; UOS Fase 1 00168 Roma ItalyAktiv, nicht rekrutierend» Google-MapsAsst Degli Spedali Civili Di Brescia 25123 Brescia ItalyAktiv, nicht rekrutierend» Google-MapsIrccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 20133 Milano ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica 20133 Milano ItalyRekrutierend» Google-MapsDipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita 10126 Torino ItalyRekrutierend» Google-MapsAzienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica 50139 Firenze ItalyRekrutierend» Google-MapsAzienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica 53100 Siena ItalyRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Chiba JapanAktiv, nicht rekrutierend» Google-MapsKindai University Hospital 589-8511 Osaka JapanAktiv, nicht rekrutierend» Google-MapsNational Cancer Center Hospital 104-0045 Tokyo JapanRekrutierend» Google-MapsSeoul National University Bundang Hospital 463-707 Seongnam-si Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSeoul National University Hospital- Adult Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital- Pediatric Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSamsung Medical Center- Adult Site 06351 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSamsung Medical Center- Pediatric Site 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsPrinses Maxima Centrum 3584 CS Utrecht NetherlandsZurückgezogen» Google-MapsAuckland City Hospital, Cancer and Blood Research 1023 Auckland New ZealandRekrutierend» Google-MapsChristchurch Hospital; Dept of Oncology Christchurch New ZealandZurückgezogen» Google-MapsUniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii 80-214 Gdansk PolandAktiv, nicht rekrutierend» Google-MapsNarod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers 02-781 Warszawa PolandRekrutierend» Google-MapsIPO do Porto; Servico de Oncologia Medica 4200-072 Porto PortugalRekrutierend» Google-MapsPanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center 00935 San Juan Puerto RicoRekrutierend» Google-MapsNational University Hospital; National University Cancer Institute, Singapore (NCIS) 119228 Singapore SingaporeRekrutierend» Google-MapsNational Cancer Centre; Medical Oncology 168583 Singapore SingaporeAktiv, nicht rekrutierend» Google-MapsMedical Oncology Centre of Rosebank; Oncology 2196 Johannesburg South AfricaRekrutierend» Google-MapsHospital Sant Joan De Deu 08950 Esplugues De Llobregas SpainRekrutierend» Google-MapsHospital Univ Vall d'Hebron; Servicio de Oncologia 08740 Sant Andreu de La Barca SpainRekrutierend» Google-MapsVall d?Hebron Institute of Oncology (VHIO), Barcelona 08035 Barcelona SpainAktiv, nicht rekrutierend» Google-MapsHospital Infantil Universitario Nino Jesus 28009 Madrid SpainRekrutierend» Google-MapsClinica Universidad de Navarra Madrid; Servicio de Oncología 28027 Madrid SpainRekrutierend» Google-MapsSTART Madrid-FJD, Hospital Fundacion Jimenez Diaz 28040 Madrid SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario 12 de Octubre; Servicio de Oncologia 28041 Madrid SpainRekrutierend» Google-MapsHospital Universitario La Paz; Servicio de Oncologia 28046 Madrid SpainRekrutierend» Google-MapsSTART Madrid. Centro Integral Oncologico Clara Campal; CIOCC 28050 Madrid SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario la Fe; Servicio de Oncologia 46026 Valencia SpainRekrutierend» Google-MapsUniversitätsspital Basel (USB) 4031 Basel SwitzerlandZurückgezogen» Google-MapsOspedale Regionale di Bellinzona Medizin Onkologie 6500 Bellinzona SwitzerlandZurückgezogen» Google-MapsInselspital, Klinik und Poliklinik für Medizinische Onkologie 3010 Bern SwitzerlandAktiv, nicht rekrutierend» Google-MapsUnversitätsspital Zürich 8091 Zürich SwitzerlandZurückgezogen» Google-MapsTaichung Veterans General Hospital; Division of Hema-Oncology 40705 Taichung TaiwanRekrutierend» Google-MapsNational Cheng Kung University Hospital; Oncology 00704 Tainan TaiwanAktiv, nicht rekrutierend» Google-MapsTaipei Veterans General Hospital; Department of Oncology 112201 Taipei City TaiwanRekrutierend» Google-MapsChang Gung Memorial Hospital-Linkou; Dept of Oncology 333 Taoyuan County TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital; Oncology 10048 Zhongzheng Dist. TaiwanAktiv, nicht rekrutierend» Google-MapsBeatson West of Scotland Cancer Centre G12 0YN Glasgow United KingdomRekrutierend» Google-MapsUniversity College London Hospital N7 9NH London United KingdomRekrutierend» Google-MapsGuys and St Thomas NHS Foundation Trust, Guys Hospital SE1 9RT London United KingdomRekrutierend» Google-MapsRoyal Manchester Children?s Hospital M13 9WL Manchester United KingdomRekrutierend» Google-MapsThe Christie NHS Foundation Trust M20 4BX Manchester United KingdomRekrutierend» Google-Maps
1. All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - Approximately up to 12 years): Confirmed objective response indicates >/= 4 weeks after initial documentation of response
Secondary outcome:
1. All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1 (Time Frame - Approximately up to 12 years)
2. All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1 (Time Frame - Approximately up to 12 years)
3. All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1 (Time Frame - Approximately up to 12 years)
4. All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
5. All Cohorts: INV-assessed DOR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
6. All Cohorts: INV-assessed CBR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
7. All Cohorts: INV-assessed PFS per RECIST v1.1 (Time Frame - Approximately up to 12 years)
8. All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1 (Time Frame - Approximately up to 12 years)
9. All Cohorts: Overall Survival (OS) (Time Frame - Approximately up to 12 years)
10. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO) (Time Frame - Approximately up to 12 years)
11. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO (Time Frame - Approximately up to 12 years)
12. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO (Time Frame - Approximately up to 12 years)
13. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO (Time Frame - Approximately up to 12 years)
14. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO (Time Frame - Approximately up to 12 years)
15. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO (Time Frame - Approximately up to 12 years)
16. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO (Time Frame - Approximately up to 12 years)
17. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO (Time Frame - Approximately up to 12 years)
18. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC) (Time Frame - Approximately up to 12 years)
19. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: KIRC-assessed DOR per INRC (Time Frame - Approximately up to 12 years)
20. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed CBR per INRC (Time Frame - Approximately up to 12 years)
21. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed PFS per INRC (Time Frame - Approximately up to 12 years)
22. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed ORR per INRC (Time Frame - Approximately up to 12 years)
23. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed DOR per INRC (Time Frame - Approximately up to 12 years)
24. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed CBR per INRC (Time Frame - Approximately up to 12 years)
25. Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed PFS per INRC (Time Frame - Approximately up to 12 years)
26. All Cohorts: IRC-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive circulating tumor DNA (ctDNA) by blood-based next-generation sequencing (NGS) assay (Time Frame - Approximately up to 12 years)
27. All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
28. All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
29. All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
30. All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
31. All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
32. All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
33. All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay (Time Frame - Approximately up to 12 years)
34. Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
35. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
36. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
37. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1 (Time Frame - Approximately up to 12 years)
38. Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
39. Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
40. Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1 (Time Frame - Approximately up to 12 years)
41. Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1 (Time Frame - Approximately up to 12 years)
42. All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) (Time Frame - Approximately up to 12 years): The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.
43. All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score (Time Frame - Approximately up to 12 years)
44. All Cohorts: Percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30 (Time Frame - Approximately up to 12 years)
45. All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library (Time Frame - Approximately up to 12 years): The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.
46. All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Approximately up to 12 years): Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)
47. Cohorts A, B: Plasma concentration of entrectinib at specified timepoints (Time Frame - Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days))
48. Cohort C: Plasma concentration of alectinib at specified timepoints (Time Frame - Cycle 1, Day 1 and Day 15; Day 1 of Cycle 2-6, and Day 1 of every other Cycle going forward (one Cycle=28 days))
49. Cohort D: Plasma concentration of atezolizumab at specified timepoints (Time Frame - Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days))
50. Cohort E: Plasma concentration of ipatasertib at specified timepoints (Time Frame - Cycle 1, Day 1 and 15; Cycle 2, Day 1; Cycle 3, Day 15; Cycle 4, Day 1, and every even Cycle thereafter (one Cycle=28 days))
51. Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints (Time Frame - Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days))
52. Cohort G: Plasma concentration of idasanutlin at specified timepoint (Time Frame - Cycle 1, Day 1, 2, 5, 8; Cycle 2, Day 1, 2, 5; Cycle 3, Day 2, 5; Cycle 4, Day 1, and every other Cycle going forward (one Cycle=28 days))
53. Cohort H: Plasma concentration of GDC-0077 at specified timepoints (Time Frame - Cycle 1, Day 1, 8 (+/-1 day), 15 (+/-1 day); Cycle 2, Day 1 (+/-1 day); Day 1 of Cycle 4, and every other even Cycle going forward (one Cycle=28 days))
54. Cohort L: Plasma concentration of GDC-6036 at specified timepoints (Time Frame - Cycle 1: Day 1, 15; Cycles 2-5, Day 1, Cycle 7, Day 1 and every other cycle until post 1-year of treatment (Day of Cycles 7, 9, 11) (Cycle=21 days)))
55. Cohort M: Plasma concentration of Camonsertib at specified timepoints (Time Frame - Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days)))
56. Cohort N: Plasma concentration of Camonsertib at specified timepoints (Time Frame - Cycle 1, Day 1, 2, 8; Cycle 2-4, Day 1; Cycle 5, Day 1, and every odd cycle until post 1-year of treatment (Cycles 7, 9, 11, and 13) (Cycle=21 days)))
57. Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA) (Time Frame - Cohort D: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days); Cohort F: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (one Cycle=21 days))
Experimental: Cohort A: ROS1 Fusion-positive tumors (excluding NSCLC) Participants with metastatic or advanced solid tumors, with the exception of NSCLC will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) >/= 1.51 squaremeter (m2). The total dose of daily entrectinib administration for pediatric participants with BSA<1.51 m2 will be lower.
Experimental: Cohort B: NTRK1/2/3 fusion-positive tumors Participants with metastatic or advanced solid tumors will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA >/= 1.51 m2. The total dose of daily entrectinib administration for pediatric participants with BSA<1.51 m2 will be lower.
Experimental: Cohort C: ALK fusion-positive tumors (excluding NSCLC) Participants with metastatic or advanced solid tumors, with the exception of NSCLC, will receive alectinib at a dosage of 600 mg orally twice a day (BID), taken with food, in repeated 28-day cycles.
Experimental: Cohort D: TMB-high tumors Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged >/= 18 years, and 15 mg/kg (maximum 1200 mg) for participants aged < 18 years on Day 1 of each 21-day cycle.
Note: Cohort D has been closed for enrollment
Experimental: Cohort E: AKT1/2/3 mutant-positive tumors Participants with metastatic or advanced solid tumors will receive ipatasertib orally once daily (QD) at the starting dose of 400 mg in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants <35 kg, 300 mg for participants >/= 35 and <45 kg, 400 mg for those >/=45 kg orally QD in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
Note: Cohort E has been closed for enrollment
Experimental: Cohort F: HER2 mutant-positive tumors Participants with metastatic or advanced solid tumors will receive trastuzumab emtansine IV at a dose of 3.6 mg/kg every 21 days.
Note: Cohort F has been closed for enrollment
Experimental: Cohort G: MDM2-amplified, TP53 wild-type tumors Participants with metastatic or advanced solid tumors will receive idasanutlin at a dose of 250 mg orally QD on Days 1-5 of each 28-day cycle.
Note: Cohort G has been closed for enrollment
Experimental: Cohort H: PIK3CA multiple mutant-positive tumors Participants with metastatic or advanced solid tumors will receive GDC-0077 QD at a starting dose of 9 mg by mouth (PO) in repeated 28-day cycles.
Note: Cohort H has been closed for enrollment
Experimental: Cohort I: BRAF class II mutant or fusion-positive tumors Participants with BRAF class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
Note: Cohort I has been closed for enrollment
Experimental: Cohort J: BRAF class III mutant-positive tumors Participants with BRAF class III mutant-positive tumors(adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
Note: Cohort J has been closed for enrollment
Experimental: Cohort K: RET fusion-positive tumors (excluding NSCLC) Participants with RET fusion-positive tumors will self-administer Pralsetinib orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).
Note: Cohort K has been closed for enrollment
Experimental: Cohort L: KRAS G12C-positive tumors (excluding NSCLC and CRC) Participants with KRAS G12C-positive tumors will self-administer GDC-6036 orally at home (except on clinic days).
Experimental: Cohort M: ATM Loss of Function tumors Participants with ATM Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).
Experimental: Cohort N: SETD2 Loss of Function tumors Participants with SETD2 Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).
Entrectinib (Rozlytrek): Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
Entrectinib (Rozlytrek): Adults and pediatric participants with a BSA >/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA < 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).
Alectinib (Alecensa): Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
Atezolizumab (Tecentriq): Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged >/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged <18 years on Day 1 of each 21-day cycle.
Ipatasertib: For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants < 35 kg, 300 mg for participants >/= 35 and < 45 kg, 400 mg for those >/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.
Trastuzumab emtansine (Kadcyla): Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.
Idasanutlin: Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart.
Note: Cohort G has been closed for enrollment.
Inavolisib (GDC-0077): GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.
Belvarafenib: Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.
Pralsetinib (Gavreto (US)): Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).
GDC-6036: GDC-6036 will be self-administered by patients orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric patients. A treatment cycle consists of 3 weeks (21 days).
Camonsertib: Camonsertib will be self-administered by patients orally at home (except on clinic days). A treatment cycle consists of 3 weeks and will be given on days 1-3 and days 8-10 of every 21-day cycle.
Quelle: ClinicalTrials.gov
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