RECRUITING

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

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Conditions

Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Quick Facts

Study Start:2021-01-18
Study Completion:2032-09-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04589845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  2. * 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)
  3. * 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%
  4. * For participants aged \>= 18 and \<18 years: adequate hematologic and end-organ function
  5. * Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  6. * Adequate recovery from most recent systemic or local treatment for cancer
  7. * Life expectancy \>= 8 weeks
  8. * Ability to comply with the study protocol, in the investigator's judgment
  9. * 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
  10. * For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  11. * In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
  1. * Current participation or enrollment in another therapeutic clinical trial
  2. * Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
  3. * Whole brain radiotherapy within 14 days prior to start of study treatment
  4. * Stereotactic radiosurgery within 7 days prior to start of study treatment
  5. * Pregnant or breastfeeding, or intending to become pregnant during the study
  6. * 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
  7. * 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
  8. * 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
  9. * 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
  10. * 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

Contacts and Locations

Study Contact

Reference Study ID Number: BO41932 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
Global-Roche-Genentech-Trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Southern Cancer Center
Daphne, Alabama, 36526
United States
Western Regional Medical Center at Cancer Treatment Centers of America
Goodyear, Arizona, 85338
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
Kaiser Permanente Los Angeles; Clinic/Infusion -LA
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 of California at San Francisco
San Francisco, California, 94115
United States
Sarcoma Oncology Center
Santa Monica, California, 90403
United States
Children's Hospital Colorado; Center For Cancer/Blood Disorder
Aurora, Colorado, 80045
United States
Christiana Care Health Srvcs; Helen F Graham Can Center
Newark, Delaware, 19713
United States
University of Florida
Gainesville, Florida, 32607
United States
Miami Cancer Institute of Baptist Health, Inc.
Miami, Florida, 33176
United States
Ocala Oncology Center
Ocala, Florida, 34471
United States
University Cancer & Blood Center, LLC; Research
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
New England Cancer Specialists
Scarborough, Maine, 04074
United States
Maryland Hematology & Oncology. P.A.
Silver Spring, Maryland, 20904
United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
United States
Washington University
Saint Louis, Missouri, 63128
United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, 59102
United States
Nebraska Methodist Hospital; Cancer Center
Omaha, Nebraska, 68114
United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, 89169
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
University of New Mexico; Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
United States
Montefiore Einstein Center for Cancer Care
Bronx, New York, 10461
United States
Eastchester Center for Cancer Care
Bronx, New York, 10469
United States
New York Cancer and Blood Specialists - Setauket Medical Oncology
East Setauket, New York, 11733
United States
National Translational Research Group
New York, New York, 10028
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
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Barrett Cancer Center
Cincinnati, Ohio, 45219
United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania, 19008
United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Cancer Treatment Centers of America; Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
United States
PRISMA Health - Greenville
Greenville, South Carolina, 29605
United States
The West Clinic; West Cancer Center
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
Cook Childrens Medical Center
Fort Worth, Texas, 76104
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
Virginia Cancer Specialists - Leesburg
Leesburg, Virginia, 20176
United States
Northwest Medical Specialties, PLLC; Research Department
Tacoma, Washington, 98405
United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-18
Study Completion Date2032-09-25

Study Record Updates

Study Start Date2021-01-18
Study Completion Date2032-09-25

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors