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

Running, not enrolling · Phase 2

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID: NCT04589845
Run by: Hoffmann-La Roche
People needed: 920
Starts: 2021-01-18
Expected to finish: 2032-09-25
Last updated by the study team: 2026-08-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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
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

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
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

Where it is running

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
Western Regional Medical Center at Cancer Treatment Centers of America — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.