Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
3 other identifiers
interventional
920
23 countries
114
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Longer than P75 for phase_2
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 25, 2032
May 8, 2026
May 1, 2026
11.7 years
October 11, 2020
May 6, 2026
Conditions
Outcome Measures
Primary Outcomes (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)
Confirmed objective response indicates ≥4 weeks after initial documentation of response.
Approximately up to 12 years
Secondary Outcomes (40)
All Cohorts: IRC-assessed Duration of Response (DOR) per RECIST v1.1
Approximately up to 12 years
All Cohorts: IRC-assessed Clinical Benefit Rate (CBR) per RECIST v1.1
Approximately up to 12 years
All Cohorts: IRC-assessed Progression-free Survival (PFS) per RECIST v1.1
Approximately up to 12 years
All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1
Approximately up to 12 years
All Cohorts: INV-assessed DOR per RECIST v1.1
Approximately up to 12 years
- +35 more secondary outcomes
Study Arms (13)
Cohort A: ROS Proto-oncogene 1 (ROS1) Fusion-positive Tumors (Excluding NSCLC)
EXPERIMENTALParticipants with metastatic or advanced solid tumors, with the exception of non-small cell lung cancer (NSCLC), will receive entrectinib once daily (QD) 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 square meter (m\^2). The total dose of daily entrectinib administration for pediatric participants with BSA \< 1.51 m\^2 will be lower.
Cohort B: Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Fusion-positive Tumors
EXPERIMENTALParticipants with metastatic or advanced solid tumors will receive entrectinib, QD in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA ≥ 1.51 m\^2. The total dose of daily entrectinib administration for pediatric participants with BSA \< 1.51 m\^2 will be lower.
Cohort C: Anaplastic Lymphoma Kinase (ALK) Fusion-positive Tumors (Excluding NSCLC)
EXPERIMENTALParticipants 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.
Cohort D: TMB-high Tumors
EXPERIMENTALParticipants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged ≥ 18 years, and 15 milligrams per kilogram (mg/kg) (maximum 1200 mg) for participants aged \< 18 years on Day 1 of each 21-day cycle. Note: Cohort D has been closed.
Cohort E: Protein Kinase B (AKT) 1/2/3 Mutant-positive Tumors
EXPERIMENTALParticipants with metastatic or advanced solid tumors will receive ipatasertib orally, 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 kilograms (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.
Cohort F: Human Epidermal Growth Factor Receptor 2 (HER2) Mutant-positive Tumors
EXPERIMENTALParticipants 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 as of protocol version 7 because enrollment and participant follow-up have been completed.
Cohort H: PIK3CA Multiple Mutant-positive Tumors
EXPERIMENTALParticipants with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) multiple mutant-positive tumors will receive inavolisib (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.
Cohort I: BRAF Class II Mutant or Fusion-positive Tumors
EXPERIMENTALParticipants with proto-oncogene B-Raf (BRAF) class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib, PO, BID with adequate water (more than 200 milliliters \[mL\]). 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.
Cohort J: BRAF Class III Mutant-positive Tumors
EXPERIMENTALParticipants with BRAF class III mutant-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib 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. Note: Cohort J has been closed for enrollment.
Cohort K: Rearranged During Transfection (RET) Fusion-positive Tumors (Excluding NSCLC)
EXPERIMENTALParticipants 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 participants ≥ 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days). Note: Cohort K has been closed.
Cohort L: KRAS G12C-positive Tumors (Excluding NSCLC and Colorectal Cancer [CRC])
EXPERIMENTALParticipants with kirsten rat sarcoma virus (KRAS) G12C-positive tumors will self-administer divarasib (GDC-6036) orally at home (except on clinic days).
Cohort M: Ataxia-telangiectasia Mutated (ATM) Loss of Function (LOF) Tumors
EXPERIMENTALParticipants with ATM LOF tumors will self-administer camonsertib orally at home (except on clinic days). Note: Cohort M has been closed.
Cohort N: SETD2 LOF Tumors
EXPERIMENTALParticipants with methyltransferase SET (Su(var) 3-9) Enhancer of zest and Trithorax) domain-containing 2 (SETD2) LOF tumors will self-administer camonsertib orally at home (except on clinic days). Note: Cohort N has been closed.
Interventions
Alectinib will be administered orally BID with food at a dosage of 600 mg (four 150-mg capsules).
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.
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.
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 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 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 participants ≥ 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days).
Divarasib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric participants. A treatment cycle consists of 3 weeks (21 days).
Camonsertib will be self-administered by participants 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.
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.
Adults and pediatric participants with a BSA ≥1.51 m\^2: 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 m\^2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m\^2) or 300 mg/day (BSA=0.81-1.10 m\^2) or 200 mg/day (BSA=0.51-0.80 m\^2) or 300 milligrams per square meter (mg/m\^2) (BSA=0.43-0.50 m\^2).
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
- Measurable disease as defined by RECIST v1.1, RANO, or INRC
- Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
Western Regional Medical Center at Cancer Treatment Centers of America
Goodyear, Arizona, 85338, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
Hoag Memorial Hospital
Newport Beach, California, 92658, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
St. Alphonsus
Boise, Idaho, 83706, United States
Midwestern Regional Med Center
Zion, Illinois, 60099, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905, United States
Maryland Hematology & Oncology. P.A.
Silver Spring, Maryland, 20904, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, 59102, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 11101, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461, United States
Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania, 19008, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044, United States
Virginia Cancer Specialists - Leesburg
Leesburg, Pennsylvania, 20176, United States
Cancer Treatment Centers of America
Philadelphia, Pennsylvania, 19124, United States
The West Clinic
Germantown, Tennessee, 38138, United States
St. Jude Children'S Research Hospital
Memphis, Tennessee, 38105, United States
Texas Oncology - Central South
Austin, Texas, 78731, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75230, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Texas Oncology- Northeast Texas
Tyler, Texas, 75702, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Les Viviers
Charleroi, 6060, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
Hospital A. C. Camargo
São Paulo, São Paulo, 01509-010, Brazil
Clínica Onco Star - Rede D'Or
São Paulo, São Paulo, 04543-000, Brazil
BC Cancer ? Vancouver
Vancouver, British Columbia, V5Z 1J3, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1H3, Canada
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
West China Hospital - Sichuan University
Chengdu, 610047, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Zhongshan Hospital Fudan Unvierstiy
Shanghai, China
Tianjin Cancer Hospital
Tianjin, 300060, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
Rigshospitalet
København Ø, 2100, Denmark
Institut Bergonie
Bordeaux, 33076, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
Hopital de la Timone
Marseille, 13005, France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, 31059, France
Institut de Cancerologie Gustave-Roussy (IGR)
Villejuif, 94805, France
Uniklinik Essen
Essen, 45122, Germany
Georg-August-Uniklinik
Göttingen, 37075, Germany
SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
Heilbronn, 74078, Germany
Praxis für Hämatologie, Onkologie und Palliativmedizin
Mönchengladbach, 41066, Germany
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Rabin MC
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky / Ichilov Hospital
Tel Aviv, 6423906, Israel
Ospedale Pediatrico Bambino Gesù - IRCCS
Rome, Lazio, 00165, Italy
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25100, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133, Italy
Istituto Nazionale Tumori di Milano
Milan, Lombardy, 20133, Italy
Dipartimento di Scienze Pediatriche Adolescenza
Turin, Piedmont, 10126, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100, Italy
Kindai University Hospital
Osaka, 589-8511, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023, New Zealand
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gda?sk, 80-214, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, 02-781, Poland
IPO do Porto
Porto, 4200-072, Portugal
PanOncology Trials
San Juan, 00935, Puerto Rico
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre
Singapore, 168583, Singapore
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Seoul National University Hospital- Adult Site
Seoul, 03080, South Korea
Seoul National University Hospital- Pediatric Site
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center- Adult Site
Seoul, 06351, South Korea
Samsung Medical Center- Pediatric Site
Seoul, 06351, South Korea
Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, 08950, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital Infantil Universitario Nino Jesus
Madrid, 28009, Spain
Clinica Universidad de Navarra Madrid
Madrid, 28027, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Universitario la Fe
Valencia, 46026, Spain
Inselspital, Klinik und Poliklinik für Medizinische Onkologie
Bern, 3010, Switzerland
National Cheng Kung University Hospital
Tainan, 00704, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
Chang Gung Memorial Hospital-Linkou
Taoyuan County, 333, Taiwan
National Taiwan University Hospital
Zhongzheng Dist., 10048, Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
University College London Hospital
London, NW1 - 2PG, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (2)
Bagchi A, Chiang J, Pinto S, Dhanda S, Gajjar A. Infant-Type Hemispheric Gliomas: A Review of Clinical, Radiologic, Histopathologic, and Molecular Features. J Natl Compr Canc Netw. 2025 Nov;23(11):e257064. doi: 10.6004/jnccn.2025.7064.
PMID: 41213248DERIVEDDesai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, Andre N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E. Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Eur J Cancer. 2025 May 2;220:115308. doi: 10.1016/j.ejca.2025.115308. Epub 2025 Feb 22.
PMID: 40086048DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2020
First Posted
October 19, 2020
Study Start
January 18, 2021
Primary Completion (Estimated)
September 25, 2032
Study Completion (Estimated)
September 25, 2032
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing