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


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Be Part of Research - Trial Details - Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
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Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Recruiting

Open to: ALL

Age: All

London London Manchester Glasgow Manchester

Medical Conditions

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2021 Sep 2032

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Adults and pediatric participants with a BSA \>/= 1.51 m2: 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 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).

Intervention Arm Group : Cohort A: ROS1 Fusion-positive tumors (excluding NSCLC);

Intervention Type : DRUG
Intervention Description : Adults and pediatric participants with a BSA \>/= 1.51 m2: 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 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).

Intervention Arm Group : Cohort B: NTRK1/2/3 fusion-positive tumors;

Intervention Type : DRUG
Intervention Description : Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).

Intervention Arm Group : Cohort C: ALK fusion-positive tumors (excluding NSCLC);

Intervention Type : DRUG
Intervention 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.

Intervention Arm Group : Cohort D: TMB-high tumors;

Intervention Type : DRUG
Intervention 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.

Intervention Arm Group : Cohort E: AKT1/2/3 mutant-positive tumors;

Intervention Type : DRUG
Intervention 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.

Intervention Arm Group : Cohort F: HER2 mutant-positive tumors;

Intervention Type : DRUG
Intervention Description : Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart.

Note: Cohort G has been closed for enrollment.

Intervention Arm Group : Cohort G: MDM2-amplified, TP53 wild-type tumors;

Intervention Type : DRUG
Intervention 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.

Intervention Arm Group : Cohort H: PIK3CA multiple mutant-positive tumors;

Intervention Type : DRUG
Intervention 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.

Intervention Arm Group : Cohort I: BRAF class II mutant or fusion-positive tumors;Cohort J: BRAF class III mutant-positive tumors;

Intervention Type : DRUG
Intervention 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 patients ≥ 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Intervention Arm Group : Cohort K: RET fusion-positive tumors (excluding NSCLC);

Intervention Type : DRUG
Intervention Description : GDC-6036 will be self-administered by patients orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric patients. A treatment cycle consists of 3 weeks (21 days).

Intervention Arm Group : Cohort L: KRAS G12C-positive tumors (excluding NSCLC and CRC);

Intervention Type : DRUG
Intervention Description : Camonsertib will be self-administered by patients 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.

Intervention Arm Group : Cohort M: ATM Loss of Function tumors;Cohort N: SETD2 Loss of Function tumors;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University College London Hospital
    London
    NW1 - 2PG
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital
    London
    SE1 9RT
  • Royal Manchester Children?s Hospital
    Manchester
    M13 9WL
  • Beatson West of Scotland Cancer Centre
    Glasgow
    G12 0YN
  • The Christie NHS Foundation Trust
    Manchester
    M20 4BX

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



The study is sponsored by Hoffmann-La Roche



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Read full details for Trial ID: NCT04589845
Last updated 15 January 2025

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