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ACTIVE NOT RECRUITING

NCT04589845

PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

920

Start Date

2021-01-18

Completion Date

2032-09-25

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Solid Tumors

Interventions

DRUG

Entrectinib

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).

DRUG

Entrectinib

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).

DRUG

Alectinib

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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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

DRUG

Divarasib

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).

DRUG

Camonsertib

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.

Inclusion Criteria: * 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 * 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

Locations (113)

Western Regional Medical Center at Cancer Treatment Centers of America

Goodyear, Arizona, United States

Kaiser Permanente Los Angeles

Los Angeles, California, United States

USC Norris Cancer Center

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

St. Alphonsus

Boise, Idaho, United States

Midwestern Regional Med Center

Zion, Illinois, United States

Horizon Oncology Research, Inc.

Lafayette, Indiana, United States

Maryland Hematology & Oncology. P.A.

Silver Spring, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

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

Billings, Montana, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, 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

Montefiore Einstein Center for Cancer Care

The Bronx, New York, United States

Barrett Cancer Center

Cincinnati, Ohio, United States

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Consultants in Medical Oncology and Hematology

Broomall, Pennsylvania, United States

Alliance Cancer Specialists

Horsham, Pennsylvania, United States

Virginia Cancer Specialists - Leesburg

Leesburg, Pennsylvania, United States

Cancer Treatment Centers of America

Philadelphia, Pennsylvania, United States

The West Clinic

Germantown, Tennessee, United States

St. Jude Children'S Research Hospital

Memphis, Tennessee, United States

Texas Oncology - Central South

Austin, Texas, United States

Mary Crowley Medical Research Center

Dallas, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology- Northeast Texas

Tyler, Texas, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Cliniques Universitaires St-Luc

Brussels, Belgium

GHdC Site Les Viviers

Charleroi, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Hospital A. C. Camargo

São Paulo, São Paulo, Brazil

Clínica Onco Star - Rede D'Or

São Paulo, São Paulo, Brazil

BC Cancer ? Vancouver

Vancouver, British Columbia, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Beijing Cancer Hospital

Beijing, China

Beijing Children's Hospital, Capital Medical University

Beijing, China

West China Hospital - Sichuan University

Chengdu, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Zhongshan Hospital Fudan Unvierstiy

Shanghai, China

Tianjin Cancer Hospital

Tianjin, China

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

Xi'an, China

Rigshospitalet

København Ø, Denmark

Institut Bergonie

Bordeaux, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Hopital de la Timone

Marseille, France

Institut Universitaire du Cancer de Toulouse-Oncopole

Toulouse, France

Institut de Cancerologie Gustave-Roussy (IGR)

Villejuif, France

Uniklinik Essen

Essen, Germany

Georg-August-Uniklinik

Göttingen, Germany

SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

Heilbronn, Germany

Praxis für Hämatologie, Onkologie und Palliativmedizin

Mönchengladbach, Germany

Hong Kong Children's Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital

Shatin, Hong Kong

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

Rabin MC

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Sourasky / Ichilov Hospital

Tel Aviv, Israel

Ospedale Pediatrico Bambino Gesù - IRCCS

Rome, Lazio, Italy

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

Istituto Nazionale Tumori di Milano

Milan, Lombardy, Italy

Dipartimento di Scienze Pediatriche Adolescenza

Turin, Piedmont, Italy

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

Siena, Tuscany, Italy

Kindai University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

Auckland City Hospital, Cancer and Blood Research

Auckland, New Zealand

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gda?sk, Poland

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

Warsaw, Poland

IPO do Porto

Porto, Portugal

PanOncology Trials

San Juan, Puerto Rico

National University Hospital

Singapore, Singapore

National Cancer Centre

Singapore, Singapore

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Seoul National University Hospital- Adult Site

Seoul, South Korea

Seoul National University Hospital- Pediatric Site

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center- Adult Site

Seoul, South Korea

Samsung Medical Center- Pediatric Site

Seoul, South Korea

Hospital Sant Joan De Deu

Esplugues de Llobregas, Barcelona, Spain

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

Barcelona, Spain

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

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

Clinica Universidad de Navarra Madrid

Madrid, Spain

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

START Madrid. Centro Integral Oncologico Clara Campal

Madrid, Spain

Hospital Universitario la Fe

Valencia, Spain

Inselspital, Klinik und Poliklinik für Medizinische Onkologie

Bern, Switzerland

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital-Linkou

Taoyuan, Taiwan

National Taiwan University Hospital

Zhongzheng Dist., Taiwan

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

University College London Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (113)