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NCT04589845 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-09-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants 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.
    intervention Names
    1. Drug: Entrectinib
    label
    Cohort A: ROS Proto-oncogene 1 (ROS1) Fusion-positive Tumors (Excluding NSCLC)
    type
    EXPERIMENTAL
  2. description
    Participants 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.
    intervention Names
    1. Drug: Entrectinib
    label
    Cohort B: Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Fusion-positive Tumors
    type
    EXPERIMENTAL
  3. description
    Participants 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.
    intervention Names
    1. Drug: Alectinib
    label
    Cohort C: Anaplastic Lymphoma Kinase (ALK) Fusion-positive Tumors (Excluding NSCLC)
    type
    EXPERIMENTAL
  4. description
    Participants 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.
    intervention Names
    1. Drug: Atezolizumab
    label
    Cohort D: TMB-high Tumors
    type
    EXPERIMENTAL
  5. description
    Participants 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.
    intervention Names
    1. Drug: Ipatasertib
    label
    Cohort E: Protein Kinase B (AKT) 1/2/3 Mutant-positive Tumors
    type
    EXPERIMENTAL
  6. description
    Participants 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.
    intervention Names
    1. Drug: Trastuzumab emtansine
    label
    Cohort F: Human Epidermal Growth Factor Receptor 2 (HER2) Mutant-positive Tumors
    type
    EXPERIMENTAL
  7. description
    Participants 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.
    intervention Names
    1. Drug: Inavolisib
    label
    Cohort H: PIK3CA Multiple Mutant-positive Tumors
    type
    EXPERIMENTAL
  8. description
    Participants 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.
    intervention Names
    1. Drug: Belvarafenib
    label
    Cohort I: BRAF Class II Mutant or Fusion-positive Tumors
    type
    EXPERIMENTAL
  9. description
    Participants 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.
    intervention Names
    1. Drug: Belvarafenib
    label
    Cohort J: BRAF Class III Mutant-positive Tumors
    type
    EXPERIMENTAL
  10. description
    Participants 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.
    intervention Names
    1. Drug: Pralsetinib
    label
    Cohort K: Rearranged During Transfection (RET) Fusion-positive Tumors (Excluding NSCLC)
    type
    EXPERIMENTAL
  11. description
    Participants with kirsten rat sarcoma virus (KRAS) G12C-positive tumors will self-administer divarasib (GDC-6036) orally at home (except on clinic days).
    intervention Names
    1. Drug: Divarasib
    label
    Cohort L: KRAS G12C-positive Tumors (Excluding NSCLC and Colorectal Cancer [CRC])
    type
    EXPERIMENTAL
  12. description
    Participants with ATM LOF tumors will self-administer camonsertib orally at home (except on clinic days). Note: Cohort M has been closed.
    intervention Names
    1. Drug: Camonsertib
    label
    Cohort M: Ataxia-telangiectasia Mutated (ATM) Loss of Function (LOF) Tumors
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort A: ROS Proto-oncogene 1 (ROS1) Fusion-positive Tumors (Excluding NSCLC)
    description
    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).
    name
    Entrectinib
    other Names
    1. Rozlytrek
    type
    DRUG
  2. arm Group Labels
    1. Cohort B: Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Fusion-positive Tumors
    description
    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).
    name
    Entrectinib
    other Names
    1. Rozlytrek
    type
    DRUG
  3. arm Group Labels
    1. Cohort C: Anaplastic Lymphoma Kinase (ALK) Fusion-positive Tumors (Excluding NSCLC)
    description
    Alectinib will be administered orally BID with food at a dosage of 600 mg (four 150-mg capsules).
    name
    Alectinib
    other Names
    1. Alecensa
    type
    DRUG
  4. arm Group Labels
    1. Cohort D: TMB-high Tumors
    description
    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.
    name
    Atezolizumab
    other Names
    1. Tecentriq
    type
    DRUG
  5. arm Group Labels
    1. Cohort E: Protein Kinase B (AKT) 1/2/3 Mutant-positive Tumors
    description
    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.
    name
    Ipatasertib
    type
    DRUG
  6. arm Group Labels
    1. Cohort F: Human Epidermal Growth Factor Receptor 2 (HER2) Mutant-positive Tumors
    description
    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.
    name
    Trastuzumab emtansine
    other Names
    1. Kadcyla
    type
    DRUG
  7. arm Group Labels
    1. Cohort H: PIK3CA Multiple Mutant-positive Tumors
    description
    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.
    name
    Inavolisib
    other Names
    1. GDC-0077
    type
    DRUG
  8. arm Group Labels
    1. Cohort I: BRAF Class II Mutant or Fusion-positive Tumors
    2. Cohort J: BRAF Class III Mutant-positive Tumors
    description
    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.
    name
    Belvarafenib
    type
    DRUG
  9. arm Group Labels
    1. Cohort K: Rearranged During Transfection (RET) Fusion-positive Tumors (Excluding NSCLC)
    description
    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).
    name
    Pralsetinib
    other Names
    1. Gavreto (US)
    type
    DRUG
  10. arm Group Labels
    1. Cohort L: KRAS G12C-positive Tumors (Excluding NSCLC and Colorectal Cancer [CRC])
    description
    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).
    name
    Divarasib
    other Names
    1. GDC-6036
    type
    DRUG
  11. arm Group Labels
    1. Cohort M: Ataxia-telangiectasia Mutated (ATM) Loss of Function (LOF) Tumors
    2. Cohort N: SETD2 LOF Tumors
    description
    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.
    name
    Camonsertib
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
920
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Confirmed objective response indicates ≥4 weeks after initial documentation of response.
    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
secondary Outcomes
  1. measure
    All Cohorts: IRC-assessed Duration of Response (DOR) per RECIST v1.1
    time Frame
    Approximately up to 12 years
  2. measure
    All Cohorts: IRC-assessed Clinical Benefit Rate (CBR) per RECIST v1.1
    time Frame
    Approximately up to 12 years
  3. measure
    All Cohorts: IRC-assessed Progression-free Survival (PFS) per RECIST v1.1
    time Frame
    Approximately up to 12 years
  4. measure
    All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1
    time Frame
    Approximately up to 12 years
  5. measure
    All Cohorts: INV-assessed DOR per RECIST v1.1
    time Frame
    Approximately up to 12 years
  6. measure
    All Cohorts: INV-assessed CBR per RECIST v1.1
    time Frame
    Approximately up to 12 years
  7. measure
    All Cohorts: INV-assessed PFS per RECIST v1.1
    time Frame
    Approximately up to 12 years
  8. measure
    All Cohorts: IRC- and INV-assessed Time to Central Nervous System (CNS) Progression per RECIST v1.1
    time Frame
    Approximately up to 12 years
  9. measure
    All Cohorts: Overall Survival (OS)
    time Frame
    Approximately up to 12 years
  10. measure
    Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-oncology (RANO)
    time Frame
    Approximately up to 12 years
  11. measure
    Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO
    time Frame
    Approximately up to 12 years
  12. measure
    Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO
    time Frame
    Approximately up to 12 years
Full study description
brief 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.
Source references
references
  1. citation
    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.
    pmid
    41213248
    type
    DERIVED
  2. citation
    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.
    pmid
    40086048
    type
    DERIVED
Source notices and limitations
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        table or metastatic solid tumors with a NTRK gene fusion enrolled in one of two multicenter, open-label clinical trials: STARTRK-NG (NCT02650401) and TAPISTRY (NCT04589845). To be included in the analysis, patients were required to have received at least 1 dose of ROZLYTREK; measurable or evaluable disease at baseline; at least 6
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        (NCT02568267); adult patients.</li><li><a href="/clinicaltrials/NCT02650401">STARTRK-NG</a> (NCT02650401); pediatric patients.</li><li><a href="/clinicaltrials/NCT04589845">TAPISTRY</a> (NCT04589845); pediatric patients.</li></ul></div> <p id="_228" tabindex="-1"><strong>Efficacy.</strong> Among the 54 adult patients, the o
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        ts.</li><li><a href="/clinicaltrials/NCT02650401">STARTRK-NG</a> (NCT02650401); pediatric patients.</li><li><a href="/clinicaltrials/NCT04589845">TAPISTRY</a> (NCT04589845); pediatric patients.</li></ul></div> <p id="_228" tabindex="-1"><strong>Efficacy.</strong> Among the 54 adult patients, the overall response rate, as de
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      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice