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Solid TumorsPhase 2NCT04589845

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

A Phase 2 study testing Entrectinib, Alectinib and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 112 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Solid Tumors
What is being tested?
Entrectinib, Alectinib and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
112 sitesin 23 countries
Study dates
18 Jan 2021to 25 Sep 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

112 sites in 23 countries.

112 sites in 23 countries

United States32 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Texas Oncology - Central South

    Austin, Texas, 78731

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana

    Billings, Montana, 59102

  • St. Alphonsus

    Boise, Idaho, 83706

  • Consultants in Medical Oncology and Hematology

    Broomall, Pennsylvania, 19008

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75230

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • The West Clinic

    Germantown, Tennessee, 38138

  • Western Regional Medical Center at Cancer Treatment Centers of America

    Goodyear, Arizona, 85338

  • Alliance Cancer Specialists

    Horsham, Pennsylvania, 19044

  • Horizon Oncology Research, Inc.

    Lafayette, Indiana, 47905

  • Virginia Cancer Specialists - Leesburg

    Leesburg, Pennsylvania, 20176

  • Kaiser Permanente Los Angeles

    Los Angeles, California, 90027

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • St. Jude Children'S Research Hospital

    Memphis, Tennessee, 38105

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11101

  • Hoag Memorial Hospital

    Newport Beach, California, 92658

  • Cancer Treatment Centers of America

    Philadelphia, Pennsylvania, 19124

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Maryland Hematology & Oncology. P.A.

    Silver Spring, Maryland, 20904

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10461

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702

  • Midwestern Regional Med Center

    Zion, Illinois, 60099

Other trials in United States

Spain10 sites

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Hospital Sant Joan De Deu

    Esplugues de Llobregas, Barcelona, 08950

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario la Fe

    Valencia, 46026

Other trials in Spain

China7 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Children's Hospital, Capital Medical University

    Beijing

  • West China Hospital - Sichuan University

    Chengdu, 610047

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092

  • Zhongshan Hospital Fudan Unvierstiy

    Shanghai

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

Italy7 sites

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25100

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • Istituto Nazionale Tumori di Milano

    Milan, Lombardy, 20133

  • Ospedale Pediatrico Bambino Gesù - IRCCS

    Rome, Lazio, 00165

  • Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

    Siena, Tuscany, 53100

  • Dipartimento di Scienze Pediatriche Adolescenza

    Turin, Piedmont, 10126

Other trials in Italy

South Korea7 sites

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Seoul National University Hospital- Adult Site

    Seoul, 03080

  • Seoul National University Hospital- Pediatric Site

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center- Adult Site

    Seoul, 06351

  • Samsung Medical Center- Pediatric Site

    Seoul, 06351

Other trials in South Korea

France6 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital de la Timone

    Marseille, 13005

  • Institut Universitaire du Cancer de Toulouse-Oncopole

    Toulouse, 31059

  • Institut de Cancerologie Gustave-Roussy (IGR)

    Villejuif, 94805

Other trials in France

Belgium5 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • GHdC Site Les Viviers

    Charleroi, 6060

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Australia4 sites

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany4 sites

  • Uniklinik Essen

    Essen, 45122

  • Georg-August-Uniklinik

    Göttingen, 37075

  • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

    Heilbronn, 74078

  • Praxis für Hämatologie, Onkologie und Palliativmedizin

    Mönchengladbach, 41066

Other trials in Germany

Israel4 sites

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Rabin MC

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5262100

  • Sourasky / Ichilov Hospital

    Tel Aviv, 6423906

Other trials in Israel

Taiwan4 sites

  • National Cheng Kung University Hospital

    Tainan, 00704

  • Taipei Veterans General Hospital

    Taipei, 112201

  • Chang Gung Memorial Hospital-Linkou

    Taoyuan County, 333

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048

Other trials in Taiwan

Brazil3 sites

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

  • Hospital A. C. Camargo

    São Paulo, São Paulo, 01509-010

  • Clínica Onco Star - Rede D'Or

    São Paulo, São Paulo, 04543-000

Other trials in Brazil

Canada3 sites

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1H3

  • BC Cancer ? Vancouver

    Vancouver, British Columbia, V5Z 1J3

Other trials in Canada

United Kingdom3 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University College London Hospital

    London, NW1 - 2PG

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Hong Kong2 sites

  • Hong Kong Children's Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Japan2 sites

  • Kindai University Hospital

    Osaka, 589-8511

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

    Warsaw, 02-781

Other trials in Poland

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre

    Singapore, 168583

Other trials in Singapore

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

New Zealand1 site

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023

Other trials in New Zealand

Portugal1 site

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

Puerto Rico1 site

  • PanOncology Trials

    San Juan, 00935

Other trials in Puerto Rico

Switzerland1 site

  • Inselspital, Klinik und Poliklinik für Medizinische Onkologie

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

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.

Conditions
Solid Tumors
Being tested
Entrectinib, Alectinib, Atezolizumab, Ipatasertib, Trastuzumab emtansine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntrectinibDrug

    Also called Rozlytrek

    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).

  • EntrectinibDrug

    Also called Rozlytrek

    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 mg/m^2 (BSA=≤0.50 m^2).

  • AlectinibDrug

    Also called Alecensa

    Alectinib will be administered orally BID with food at a dosage of 600 mg (four 150-mg capsules).

  • AtezolizumabDrug

    Also called 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.

  • IpatasertibDrug

    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 emtansineDrug

    Also called 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.

  • InavolisibDrug

    Also called 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.

  • BelvarafenibDrug

    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.

  • PralsetinibDrug

    Also called 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 participants ≥ 12 and < 18 years of age. A treatment cycle consists of 4 weeks (28 days).

  • DivarasibDrug

    Also called GDC-6036

    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).

  • CamonsertibDrug

    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.

Study groups in NCT04589845
Study groupRoleWhat they receive
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.
Receives: Drug: Entrectinib
Cohort B: Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Fusion-positive TumorsExperimentalParticipants 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.
Receives: Drug: Entrectinib
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.
Receives: Drug: Alectinib
Cohort D: TMB-high TumorsExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Cohort E: Protein Kinase B (AKT) 1/2/3 Mutant-positive TumorsExperimentalParticipants 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.
Receives: Drug: Ipatasertib
Cohort F: Human Epidermal Growth Factor Receptor 2 (HER2) Mutant-positive TumorsExperimentalParticipants 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.
Receives: Drug: Trastuzumab emtansine
Cohort H: PIK3CA Multiple Mutant-positive TumorsExperimentalParticipants 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.
Receives: Drug: Inavolisib
Cohort I: BRAF Class II Mutant or Fusion-positive TumorsExperimentalParticipants 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.
Receives: Drug: Belvarafenib
Cohort J: BRAF Class III Mutant-positive TumorsExperimentalParticipants 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.
Receives: Drug: Belvarafenib
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.
Receives: Drug: Pralsetinib
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).
Receives: Drug: Divarasib
Cohort M: Ataxia-telangiectasia Mutated (ATM) Loss of Function (LOF) TumorsExperimentalParticipants with ATM LOF tumors will self-administer camonsertib orally at home (except on clinic days). Note: Cohort M has been closed.
Receives: Drug: Camonsertib
Cohort N: SETD2 LOF TumorsExperimentalParticipants 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.
Receives: Drug: Camonsertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately up to 12 years

Secondary outcomes (40)

  1. All Cohorts: IRC-assessed Duration of Response (DOR) per RECIST v1.1

    Measured: Approximately up to 12 years

  2. All Cohorts: IRC-assessed Clinical Benefit Rate (CBR) per RECIST v1.1

    Measured: Approximately up to 12 years

  3. All Cohorts: IRC-assessed Progression-free Survival (PFS) per RECIST v1.1

    Measured: Approximately up to 12 years

  4. All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1

    Measured: Approximately up to 12 years

  5. All Cohorts: INV-assessed DOR per RECIST v1.1

    Measured: Approximately up to 12 years

  6. All Cohorts: INV-assessed CBR per RECIST v1.1

    Measured: Approximately up to 12 years

  7. All Cohorts: INV-assessed PFS per RECIST v1.1

    Measured: Approximately up to 12 years

  8. All Cohorts: IRC- and INV-assessed Time to Central Nervous System (CNS) Progression per RECIST v1.1

    Measured: Approximately up to 12 years

  9. All Cohorts: Overall Survival (OS)

    Measured: 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)

    Measured: Approximately up to 12 years

  11. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO

    Measured: Approximately up to 12 years

  12. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO

    Measured: Approximately up to 12 years

  13. Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO

    Measured: Approximately up to 12 years

  14. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO

    Measured: Approximately up to 12 years

  15. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO

    Measured: Approximately up to 12 years

  16. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO

    Measured: Approximately up to 12 years

  17. Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO

    Measured: Approximately up to 12 years

  18. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)

    Measured: Approximately up to 12 years

  19. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed DOR per INRC

    Measured: Approximately up to 12 years

  20. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed CBR per INRC

    Measured: Approximately up to 12 years

  21. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: IRC-assessed PFS per INRC

    Measured: Approximately up to 12 years

  22. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed ORR per INRC

    Measured: Approximately up to 12 years

  23. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed DOR per INRC

    Measured: Approximately up to 12 years

  24. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed CBR per INRC

    Measured: Approximately up to 12 years

  25. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, N: INV-assessed PFS per INRC

    Measured: Approximately up to 12 years

  26. Cohorts A, B, C, D, I, J, K: IRC-assessed Intracranial (IC)-ORR per RECIST v1.1

    Measured: Approximately up to 12 years

  27. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1

    Measured: Approximately up to 12 years

  28. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1

    Measured: Approximately up to 12 years

  29. Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS Rate per RECIST v1.1

    Measured: Approximately up to 12 years

  30. Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1

    Measured: Approximately up to 12 years

  31. Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1

    Measured: Approximately up to 12 years

  32. Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1

    Measured: Approximately up to 12 years

  33. Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS Rate per RECIST v1.1

    Measured: Approximately up to 12 years

  34. Cohorts A, B and F: Percentage of Participants With Confirmed Deterioration as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC 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.

    Measured: Approximately up to 12 years

  35. Cohorts A, B and F: Change From Baseline in the EORTC-QLQ-C30 Total Score

    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.

    Measured: Approximately up to 12 years

  36. Cohorts A, B and F: Percentage of Participants With a Clinical Meaningful Change on the Global Health Status, Physical Functioning, and Role Functioning Scores From the EORTC 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.

    Measured: Approximately up to 12 years

  37. Cohorts A, B and F: Time to Confirmed Symptom Onset or Worsening From Tumor-related Symptom Scores From the EORTC QLQ-C30 and EORTC Item Library 71 (IL71)

    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.

    Measured: Approximately up to 12 years

  38. All Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)

    Measured: Approximately up to 12 years

  39. Cohort F: Serum Concentration of Trastuzumab Emtansine at Specified Timepoints

    Measured: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (up to approximately 25 months) (one Cycle=21 days)

  40. Cohort F: Percentage of Participants with Anti-drug Antibodies (ADA)

    Measured: Cycle 1, Day 1; Cycle 2, Day 1; Cycle 4, Day 1; Cycle 6, Day 1, and every even Cycle thereafter (up to approximately 25 months) (one Cycle=21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start18 Jan 2021
  3. Primary completion25 Sep 2032 (estimated)
  4. Study completion25 Sep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
920 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589845
Sponsor's protocol ID
BO41932
Other IDs
2020-001847-16, 2023-507418-28-00, 2023
Status last verified
Sep 2026
First submitted
11 Oct 2020
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 41213248

  • Desai 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.

    PubMed 40086048

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Entrectinib, Alectinib and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 112 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Spain, China, Italy, South Korea and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04589845, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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