Zurück zur Übersicht
SNCTP000004623 | EUCTR2020-001847-16 | BASEC2021-00425

Plattform-Studie mit Präzisions-Immunoonkologie bei fortgeschrittenen, inoperablen oder metastasierten soliden Tumoren (TAPISTRY)

Datenbasis: BASEC (Import vom 01.07.2022) , WHO (Import vom 19.05.2022)
Geändert: 19.05.2022, 14:07
Krankheitskategorie: Anderer Krebs

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Das Ziel dieser Studie ist es, die Auswirkungen, ob gut oder schlecht, von zielgerichteten Therapien (Medikamente, die bestimmte Arten von Krebszellen identifizieren und angreifen) oder Immuntherapie (Medikamente, die das körpereigene Immunsystem bei der Bekämpfung von Krebszellen unterstützen) bei Patienten mit soliden Tumoren mit spezifischen genetischen Veränderungen oder mit einer hohen Anzahl von Mutationen aufweisen. Die Patienten werden in Kohorten (Gruppen) eingeteilt, je nachdem, ob sie eine bestimmte Art von genetischer Veränderung oder eine hohe Anzahl von Mutationen in ihrem Tumor aufweisen. Anzahl von Mutationen in ihrem Tumor. Kohorte A: Entrectinib bei Patienten mit ROS1-Fusions-positiven Tumoren ∙ Gruppe Kohorte B: Entrectinib bei Patienten mit NTRK1/2/3-Fusions-positiven Tumoren ∙ Kohorte C: Alectinib bei Patienten mit ALK-Fusions-positiven Tumoren Kohorte D: Atezolizumab bei Patienten mit Tumor-Mutationslast (TMB)-hohen Tumoren Kohorte E: Ipatasertib bei Patienten mit AKT1/2/3-Mutation-positiven Tumoren Kohorte F: Trastuzumab Emtansin bei Patienten mit HER2-Mutation-positiven Tumoren Kohorte G: Idasanutlin bei Patienten mit MDM2-amplifizierten, TP53-Wildtyp-Tumoren (Gruppe wurde wegen Rekrutierungsstornierung geschlossen) Kohorte H: GDC-0077 bei Patienten mit PIK3CA-multimutierten-positiven Tumoren

Untersuchte Krankheiten(Datenquelle: BASEC)

In dieser Studie werden inoperable, lokal fortgeschrittene, inoperable oder metastasierte solide Tumore (mit bestimmten genetischen Veränderungen oder einer hoher Anzahl von Mutationen) untersucht.

Health conditions (Datenquelle: WHO)

Locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are TMB-high as identified by a validated NGS assay
MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04]

Seltene Krankheit (Datenquelle: BASEC)

Nein

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Personalisierte Therapie für jeden Patienten entweder mit Entrectinib, Alectinib, Atezolizumab, Ipatasertib, Trastuzumab emtansine oder GDC-0077 in Abhängigkeit vom molekularen Profil des Tumors. Diese Therapien zielen auf die Mutationen im Tumor.

Interventions (Datenquelle: WHO)


Trade Name: Kadcyla 160 mg powder for concentrate for solution for infusion.
Product Name: trastuzumab emtansine
Product Code: RO530-4020/F02-01
Pharmaceutical Form: Powder for concentrate and solution for solution for infusion
INN or Proposed INN: trastuzumab emtansine
CAS Number: 1018448-65-1
Current Sponsor code: RO5304020
Other descriptive name: TRASTUZUMAB EMTANSINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-

Trade Name: Tecentriq
Product Name: Atezolizumab
Product Code: RO554-1267/F03-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
Current Sponsor code: RO5541267
Other descriptive name: Tecentriq / MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Product Name: Entrectinib
Product Code: RO710-2122/F08
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ENTRECTINIB
CAS Number: 1108743-60-7
Current Sponsor code: RO7102122
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Entrectinib
Product Code: RO710-2122/F09
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ENTRECTINIB
CAS Number: 1108743-60-7
Current Sponsor code: RO7102122
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Entrectinib
Product Code: RO710-2122/F20
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ENTRECTINIB
CAS Number: 1108743-60-7
Current Sponsor code: RO7102122
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Entrectinib
Product Code: RO710-2122/F11
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ENTRECTINIB
CAS Number: 1108743-60-7
Current Sponsor code:

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

-Histologisch oder zytologisch gesicherte Diagnose eines fortgeschrittenen und inoperablen oder metastasierten soliden Malignoms
-Mindestens eines der folgenden molekularen Tumorprofile:
ROS1-Fusions-positiver Tumor, NTRK1/2/3-Fusions-positiver Tumor, ALK-Fusions-positiver Tumor, TMB-high-Tumor, AKT1/2/3-Mutation-positiver Tumor, HER2-Mutation-positiver Tumor, PIK3CA-Multimutation-positiver Tumor
-Fortschreiten der Erkrankung unter der vorherigen Behandlung oder zuvor unbehandelte Erkrankung ohne verfügbare akzeptable Behandlung.

Ausschlusskriterien (Datenquelle: BASEC)

-Ganzhirnbestrahlung innerhalb von 14 Tagen vor Beginn der Studienbehandlung
-Sterotaktische Radiochirurgie innerhalb von 7 Tagen vor Beginn der Studienbehandlung
-Schwanger oder stillend, oder beabsichtigt, während der Studie schwanger zu werden

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
• For patients whose biomarker status is unknown and/or for patients with an ineligible local NGS test result: Signed Biomarker Eligibility Testing Informed Consent Form and willingness to participate in an assigned cohort based on their identified oncogenic biomarker(s)
• For patients with a positive biomarker status: Signed cohort-specific Informed Consent Form. For pediatric patients: Informed Consent Form must be signed by either the parent(s) or a legal representative
• 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:
o Patients aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
o Patients aged 16 to < 18 years: Karnofsky score >= 50%
o Patients aged < 16 years: Lansky score >= 50%
• For patients 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 patients 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 patients: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 423
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195

Exclusion criteria:
• Current participation or enrollment in another therapeutic clinical trial
• Any anticancer treatment within 2 weeks or 5 half-lives (whichever is longer) 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 patient'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

Each cohort will also have individual molecule specific inclusion/exclusion criteria

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2020-001847-16
Weitere Informationen zur Studie

Datum der Studienregistrierung

07.04.2021

Rekrutierungsstatus

NA

Wissenschaftlicher Titel (Datenquelle: WHO)

TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)

Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: multi-cohort
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 7

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

Main Objective: • To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors. The following oncogenic genomic alterations and targeted therapy will be assessed:
o NTRK fusion-positive: entrectinib
o ROS1 fusion-positive: entrectinib
o ALK fusion-positive: alectinib
o TMB high: atezolizumab
o AKT1/2/3 mutation positive: ipatasertib
o HER2 mutation positive: trastuzumab emtansine
o MDM2-amplified idasanutlin
o PIK3CA multiple mutations: Inavolisib (GDC-0077)
o BRAF class II mutant/fusion-positive tumors: Belvarafenib
o BRAF class III mutant-positive tumors: Belvarafenib
o RET fusion-positive tumors: Pralsetinib;Secondary Objective: • Efficacy of study treatment in patients with alteration/biomarker-positive advanced/ metastatic solid tumors
• Efficacy of study treatment in patients with alteration/biomarker-positive primary CNS tumors at baseline for specific cohorts; treatment in subgroup of patients with alteration/biomarker-positive solid tumors with CNS metastases at baseline
• Efficacy of study treatment in patients with alteration/biomarker-positive advanced/ metastatic neuroblastoma for specific cohorts
• Efficacy of study treatment in subgroup of patients with advanced/ metastatic solid tumors that are alteration/biomarker-positive by blood-based NGS assay
• Impact of study treatment on PROs of function, symptoms in patients with alteration/biomarker-positive advanced/ metastatic solid tumors
• Safety, tolerability of study treatment in patients with alteration/biomarker-positive solid tumors
• Immune response to study treatment; potential effects of anti-drug antibodies (ADAs) in certain cohorts;Primary end point(s): 1. Independent review committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response;Timepoint(s) of evaluation of this end point: 1. Up to 6-8 week tumor assessments depending on specific cohorts

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): 1. IRC-assessed duration of response (DOR), clinical benefit rate(CBR), and progression –free survival (PFS) per RECIST v1.1
2. Investigator (INV)-assessed ORR, DOR, CBR, and PFS per RECIST v1.1
3. IRC- and INV-assessed time to CNS progression per RECIST v1.1
4. Overall survival
5. IRC-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
6. INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
7. IRC-assessed ORR, DOR, CBR, and PFS per INRC
8. INV-assessed ORR, DOR, CBR, and PFS per INRC
9. IRC-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 in patients with alteration/biomarker positive ctDNA by blood-based NGS assay
10. INV-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 in patients with alteration/biomarker positive ctDNA by blood-based NGS assay
11. IRC-assessed intracranial (IC)-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1
12. INV-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS per RECIST v1.1
13. Time to confirmed deterioration, change from baseline, proportion of patients with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
14. Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and Item Library
15. Incidence, type, and severity of adverse events including serious adverse events
16. Incidence of atezolizumab and trastuzumab ADAs during the study relative to the prevalence of ADAs at baseline
17. Relationship between atezolizumab and trastuzumab ADA status and efficacy, safety, or pharmacokinetic endpoints ;Timepoint(s) of evaluation of this end point: 1-17. Approximately up to 12 years

Kontakt für Auskünfte (Datenquelle: WHO)

F. Hoffman-La Roche Ltd.

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Basel, Bellinzona, Bern, Zürich

Durchführungsländer (Datenquelle: WHO)

Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Korea, Netherlands, New Zealand, Poland, Portugal, Republic of, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@roche.com

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Trial Information Support Line-TISL
Grenzacherstrasse 124
F. Hoffmann-La Roche Ltd
global.rochegenentechtrials@roche.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Trial Information Support Line-TISL
Grenzacherstrasse 124
F. Hoffmann-La Roche Ltd
global.rochegenentechtrials@roche.com

Bewilligung durch Ethikkommission (Datenquelle: BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Comitato etico cantonale Ticino

Datum der Bewilligung durch die Ethikkommission

23.09.2021

Weitere Studienidentifikationsnummern

Studienidentifikationsnummer der Ethikkommission (BASEC-ID) (Datenquelle: BASEC)

2021-00425

Secondary ID (Datenquelle: WHO)

BO41932
2020-001847-16-DK
Zurück zur Übersicht