Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

What's the purpose of this 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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* 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)
* 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%
* 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

Additional Trial Information

Phase 2

Enrollment: 920 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Southern Cancer Center

Daphne, AL

Open and Accepting


Cancer Treatment Centers of America - WRMC-Phoenix

Goodyear, AZ

Open and Accepting


City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

USC Norris Comprehensive Cancer Center University of Southern California

Los Angeles, CA

Open and Accepting

Hoag Memorial Hospital Presbyterian

Newport Beach, CA

Open and Accepting

Hoag Memorial Hospital

Newport Beach, CA

Open and Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Sarcoma Oncology Center

Santa Monica, CA

Open and Accepting


The Children's Hospital of Colorado

Aurora, CO

Open and Accepting

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting


Miami Cancer Institute Baptist Health South Florida

Miami, FL

Open and Accepting

Ocala Oncology Center

Ocala, FL

Open and Accepting


University Cancer and Blood Center

Athens, GA

Open and Accepting


Saint Alphonsus Cancer Care Center (Boise)

Boise City, ID

Open and Accepting


Maryland Hematology & Oncology. P.A.

Silver Spring, MD

Open and Accepting


Henry Ford Hospital

Detroit, MI

Open and Accepting

St. Joseph Mercy Ann Arbor Hospital

Ypsilanti, MI

Open and Accepting


Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, MN

Open and Accepting


St. Vincent Frontier Cancer Center

Billings, MT

Open and Accepting

New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, NH

Open and Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New Mexico

New York

Montefiore Medical Center

Bronx, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting


Barrett Cancer Center University of Cincinnati Health

Cincinnati, OH

Open and Accepting

Oncology Hematology Care, Inc. (Blue Ash)

Cincinnati, OH

Open and Accepting


Providence Portland Medical Center

Portland, OR

Open and Accepting


Consultants in Medical Oncology and Hematology, PC

Drexel Hill, PA

Open and Accepting

Alliance Cancer Specialist

Horsham, PA

Open and Accepting

Children's Hospital of Philadelphia

Philadelphia, PA

Open and Accepting


West Cancer Center (East Campus - Germantown) East Campus

Germantown, TN

Open and Accepting

St. Jude Children's Research Center

Memphis, TN

Open and Accepting


Texas Oncology (Austin Central) Austin Central

Austin, TX

Open and Accepting

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

Cook Children's Medical Center

Fort Worth, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting


Fairfax-Northern Virgina Hem-Onc, PC-Leesburg

Leesburg, VA

Open and Accepting



Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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