Informations générales (source: ClinicalTrials.gov)
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Interventional
Phase 2
Hoffmann-La Roche (Voir sur ClinicalTrials)
janvier 2021
septembre 2032
29 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Sophie POSTEL-VINAY | 31/05/2024 09:08:00 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie Gustave-Roussy (IGR) - 94805 - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer de Toulouse-Oncopole - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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