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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04589845
Other study ID # BO41932
Secondary ID 2020-001847-16
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 18, 2021
Est. completion date September 25, 2032

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact Reference Study ID Number: BO41932 https://forpatients.roche.com
Phone 888-662-6728 (U.S. and Canada)
Email Global-Roche-Genentech-Trials@gene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.


Recruitment information / eligibility

Status Recruiting
Enrollment 920
Est. completion date September 25, 2032
Est. primary completion date September 25, 2032
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC) - Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50% - For participants aged >= 18 and <18 years: adequate hematologic and end-organ function - Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment - Adequate recovery from most recent systemic or local treatment for cancer - Life expectancy >= 8 weeks - Ability to comply with the study protocol, in the investigator's judgment - For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period - For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria - In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort Exclusion Criteria: - Current participation or enrollment in another therapeutic clinical trial - Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment - Whole brain radiotherapy within 14 days prior to start of study treatment - Stereotactic radiosurgery within 7 days prior to start of study treatment - Pregnant or breastfeeding, or intending to become pregnant during the study - History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study - Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina - History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy - In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Entrectinib
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
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
Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).
Atezolizumab
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
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-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
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.

Locations

Country Name City State
Australia Kinghorn Cancer Centre; St Vincents Hospital Darlinghurst New South Wales
Australia Peter MacCallum Cancer Centre; Medical Oncology Melbourne Victoria
Australia Royal Children's Hospital Parkville Victoria
Australia Sydney Children's Hospital Randwick New South Wales
Australia Royal Darwin Hospital; Alan Walker Cancer Centre Tiwi Northern Territory
Australia Princess Alexandra Hospital Woolloongabba Queensland
Belgium Cliniques Universitaires St-Luc Bruxelles
Belgium GHdC Site Notre Dame Charleroi
Belgium UZ Antwerpen Edegem
Belgium UZ Gent Gent
Belgium UZ Leuven Gasthuisberg Leuven
Brazil Hospital Moinhos de Vento Porto Alegre RS
Brazil Clínica Onco Star - Rede D'Or Sao Paulo SP
Brazil Hospital A. C. Camargo; Oncologia Sao Paulo SP
Brazil Hospital Sírio-Libanês Sao Paulo SP
Brazil Hospital Sírio-Libanês Sao Paulo SP
Canada London Health Sciences Centre · Victoria Hospital; Department of Medicine London Ontario
Canada McGill University Health Center Montreal Quebec
Canada The Ottawa Hospital - General Campus Ottawa Ontario
Canada Princess Margaret Cancer Center Toronto Ontario
Canada The Hospital for Sick Children Toronto Ontario
Canada BC Cancer ? Vancouver Vancouver British Columbia
China Beijing Cancer Hospital Beijing
China Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department Beijing City
China Jilin Cancer Hospital Changchun
China The First Hospital of Jilin University Changchun City
China West China Hospital - Sichuan University Chengdu City
China Shanghai East Hospital Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai
China Zhongshan Hospital Fudan Unvierstiy Shanghai City
China Tianjin Cancer Hospital Tianjin
China First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an
Denmark Aalborg Universitetshospital Aalborg
Denmark Aarhus Universitetshospital; Kræftafdelingen Aarhus N
Denmark Rigshospitalet; Onkologisk Klinik København Ø
France Institut Bergonie; Oncologie Bordeaux
France Centre Oscar Lambret; Service de Pediatrie Lille
France CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie Lyon
France Hopital de la Timone Marseille
France Institut Universitaire du Cancer de Toulouse-Oncopole Toulouse
France Institut de Cancerologie Gustave-Roussy (IGR) Villejuif
Germany Uniklinik Essen Essen
Germany Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I Freiburg
Germany Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie Göttingen
Germany Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II Hamburg
Germany Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie Hannover
Germany Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg Heidelberg
Germany SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm. Heilbronn
Germany Praxis für Hämatologie, Onkologie und Palliativmedizin Mönchengladbach
Germany Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III München
Germany Universtitätsklinikum Ulm; Klinik für Innere Medizin III Ulm
Germany Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU Würzburg
Hong Kong Hong Kong Children's Hospital Hong Kong
Hong Kong Prince of Wales Hospital; Department of Clinical Onocology Shatin
Israel Rambam Health Care Campus; Oncology Haifa
Israel Hadassah University Hospital - Ein Kerem Jerusalem
Israel Rabin MC; Davidof Center - Oncology Institute Petach Tikva
Israel Sheba Medical Center Ramat Gan
Israel Sourasky / Ichilov Hospital; Dept. of Oncology Tel Aviv
Italy Asst Degli Spedali Civili Di Brescia Brescia Lombardia
Italy Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica Firenze Toscana
Italy Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Milano Lombardia
Italy Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica Milano Lombardia
Italy Istituto Nazionale Tumori Fondazione G. Pascale Napoli Campania
Italy Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica Roma Lazio
Italy Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1 Roma Lazio
Italy Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica Siena Toscana
Italy Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita Torino Piemonte
Japan National Cancer Center Hospital East Chiba
Japan Kindai University Hospital Osaka
Japan National Cancer Center Hospital Tokyo
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center- Adult Site Seoul
Korea, Republic of Samsung Medical Center- Pediatric Site Seoul
Korea, Republic of Seoul National University Hospital- Adult Site Seoul
Korea, Republic of Seoul National University Hospital- Pediatric Site Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Netherlands Prinses Maxima Centrum Utrecht
New Zealand Auckland City Hospital, Cancer and Blood Research Auckland
New Zealand Christchurch Hospital; Dept of Oncology Christchurch
Poland Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii Gdansk
Poland Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers Warszawa
Portugal IPO do Porto; Servico de Oncologia Medica Porto
Puerto Rico PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center San Juan
Singapore National Cancer Centre; Medical Oncology Singapore
Singapore National University Hospital; National University Cancer Institute, Singapore (NCIS) Singapore
South Africa Medical Oncology Centre of Rosebank; Oncology Johannesburg
Spain Vall d?Hebron Institute of Oncology (VHIO), Barcelona Barcelona
Spain Hospital Sant Joan De Deu Esplugues De Llobregas Barcelona
Spain Clinica Universidad de Navarra Madrid; Servicio de Oncología Madrid
Spain Hospital Infantil Universitario Nino Jesus Madrid
Spain Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Spain START Madrid-FJD, Hospital Fundacion Jimenez Diaz Madrid
Spain START Madrid. Centro Integral Oncologico Clara Campal; CIOCC Madrid
Spain Hospital Univ Vall d'Hebron; Servicio de Oncologia Sant Andreu de La Barca Barcelona
Spain Hospital Universitario la Fe; Servicio de Oncologia Valencia
Switzerland Universitätsspital Basel (USB) Basel
Switzerland Ospedale Regionale di Bellinzona Medizin Onkologie Bellinzona
Switzerland Inselspital, Klinik und Poliklinik für Medizinische Onkologie Bern
Switzerland Unversitätsspital Zürich Zürich
Taiwan Taichung Veterans General Hospital; Division of Hema-Oncology Taichung
Taiwan National Cheng Kung University Hospital; Oncology Tainan
Taiwan Taipei Veterans General Hospital; Department of Oncology Taipei City
Taiwan Chang Gung Memorial Hospital-Linkou; Dept of Oncology Taoyuan County
Taiwan National Taiwan University Hospital; Oncology Zhongzheng Dist.
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom Guys and St Thomas NHS Foundation Trust, Guys Hospital London
United Kingdom University College London Hospital London
United Kingdom Royal Manchester Children?s Hospital Manchester
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Royal Marsden Hospital (Sutton) Sutton
United States University of New Mexico; Comprehensive Cancer Center Albuquerque New Mexico
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States University Cancer & Blood Center, LLC; Research Athens Georgia
United States Children's Hospital Colorado; Center For Cancer/Blood Disorder Aurora Colorado
United States Texas Onc-Central Austin CA Ct Austin Texas
United States Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana Billings Montana
United States St. Alphonsus Boise Idaho
United States Eastchester Center for Cancer Care Bronx New York
United States Montefiore Einstein Center for Cancer Care Bronx New York
United States Consultants in Medical Oncology and Hematology Broomall Pennsylvania
United States Levine Cancer Institute Charlotte North Carolina
United States Barrett Cancer Center Cincinnati Ohio
United States Oncology Hematology Care Inc Cincinnati Ohio
United States Mary Crowley Medical Research Center Dallas Texas
United States Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Southern Cancer Center Daphne Alabama
United States Henry Ford Health System Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States New York Cancer and Blood Specialists - Setauket Medical Oncology East Setauket New York
United States Cook Childrens Medical Center Fort Worth Texas
United States University of Florida Gainesville Florida
United States The West Clinic; West Cancer Center Germantown Tennessee
United States Western Regional Medical Center at Cancer Treatment Centers of America Goodyear Arizona
United States PRISMA Health - Greenville Greenville South Carolina
United States Alliance Cancer Specialists Horsham Pennsylvania
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Horizon Oncology Research, Inc. Lafayette Indiana
United States Comprehensive Cancer Centers of Nevada - Eastern Avenue Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Virginia Cancer Specialists - Leesburg Leesburg Virginia
United States Kaiser Permanente Los Angeles; Clinic/Infusion -LA Los Angeles California
United States USC Norris Cancer Center Los Angeles California
United States St. Jude Children'S Research Hospital Memphis Tennessee
United States Miami Cancer Institute of Baptist Health, Inc. Miami Florida
United States Froedtert and The Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Icahn School of Medicine at Mount Sinai New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States National Translational Research Group New York New York
United States Christiana Care Health Srvcs; Helen F Graham Can Center Newark Delaware
United States Hoag Memorial Hospital Newport Beach California
United States Ocala Oncology Center Ocala Florida
United States Nebraska Methodist Hospital; Cancer Center Omaha Nebraska
United States Cancer Treatment Centers of America; Eastern Regional Medical Center Philadelphia Pennsylvania
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Washington University Saint Louis Missouri
United States Metro-Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States University of California at San Francisco San Francisco California
United States Sarcoma Oncology Center Santa Monica California
United States New England Cancer Specialists Scarborough Maine
United States Maryland Hematology & Oncology. P.A. Silver Spring Maryland
United States Northwest Medical Specialties, PLLC; Research Department Tacoma Washington
United States Texas Oncology- Northeast Texas Tyler Texas
United States Midwestern Regional Med Center Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Confirmed objective response indicates >/= 4 weeks after initial documentation of response Approximately up to 12 years
Secondary All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: INV-assessed DOR per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: INV-assessed CBR per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: INV-assessed PFS per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1 Approximately up to 12 years
Secondary All Cohorts: Overall Survival (OS) Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO) Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC) Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: KIRC-assessed DOR per INRC Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed CBR per INRC Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: IRC-assessed PFS per INRC Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed ORR per INRC Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed DOR per INRC Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed CBR per INRC Approximately up to 12 years
Secondary Cohorts A, B, C, D, E, F, G, H, I, J, K, L, M, N: INV-assessed PFS per INRC Approximately up to 12 years
Secondary 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 Approximately up to 12 years
Secondary All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1 Approximately up to 12 years
Secondary Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1 Approximately up to 12 years
Secondary 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) 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. Approximately up to 12 years
Secondary All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score Approximately up to 12 years
Secondary 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 Approximately up to 12 years
Secondary All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library 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. Approximately up to 12 years
Secondary All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.) Approximately up to 12 years
Secondary Cohorts A, B: Plasma concentration of entrectinib at specified timepoints Day 1 of Cycle 1-6 and Day 1 of every other Cycle going forward (one Cycle=28 days)
Secondary Cohort C: Plasma concentration of alectinib at specified timepoints 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)
Secondary Cohort D: Plasma concentration of atezolizumab at specified timepoints Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, and every even Cycles thereafter (one Cycle=21 days)
Secondary Cohort E: Plasma concentration of ipatasertib at specified timepoints 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)
Secondary Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints 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)
Secondary Cohort G: Plasma concentration of idasanutlin at specified timepoint 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)
Secondary Cohort H: Plasma concentration of GDC-0077 at specified timepoints 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)
Secondary Cohort L: Plasma concentration of GDC-6036 at specified timepoints 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))
Secondary Cohort M: Plasma concentration of Camonsertib at specified timepoints 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))
Secondary Cohort N: Plasma concentration of Camonsertib at specified timepoints 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))
Secondary Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA) 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)
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