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SNCTP000004623 | EUCTR2020-001847-16 | BASEC2021-00425

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

Datenbasis: BASEC (Import vom 14.06.2024), WHO (Import vom 13.06.2024)
Geändert: 07.06.2024, 11:43
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 Kohorte B: Entrectinib bei Patienten mit NTRK1/2/3-Fusions-positiven Tumoren Kohorte C: Alectinib bei Patienten mit ALK-Fusions-positiven Tumoren Kohorte H: GDC-0077 bei Patienten mit PIK3CA-multimutierten-positiven Tumoren Kohorte J: Belvarafenib bei Patienten mit BRAF-Klasse-III-Mutations-positiven Tumoren Kohorte K: Pralsetinib bei Patienten mit RET-Fusions-positiven Tumoren (ausser NSCLC)

Untersuchte Krankheiten(Datenquelle: BASEC)

In dieser Studie werden inoperable, lokal fortgeschrittene 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: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);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: Tecentriq
Product Name: Atezolizumab
Product Code: RO554-1267/F03
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/F09/F11/F20/F25
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/F04/F06/F10/F14/F24
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: 200-

Product Name: Entrectinib
Product Code: RO710-2122/F15/F17
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ENTRECTINIB
CAS Number: 1108743-60-7
Current Sponsor code: RO7102122
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Ipatasertib
Product Code: RO5532961/F16
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IPATASERTIB
Current Sponsor code: RO5532961
Other descriptive name: GDC-0068 / Akt Inhibitor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Ipatasertib
Product Code: RO5532961/F17
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IPATASERTIB
Current Sponsor code: RO5532961
Other descriptive name: GDC-0068 / Akt Inhibitor
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

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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)

Gender:
Female: yes
Male: yes

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: 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 <= 7 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
o Stricter cohort-specific contraception requirements may be included in the cohort-specific appendices
? 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

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 prior to start of study treatment (Please refer to the cohort-specific eligibility criteria for requirements on enrollment, if applicable)
? 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

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

11.11.2020

Einschluss der ersten teilnehmenden Person

30.06.2021

Rekrutierungsstatus

Authorised-recruitment may be ongoing or finished

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: 13

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 (for tumor types that are assessed by RECIST v1.1) based on IRC-assessed ORR;Secondary Objective: ? To evaluate efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors, alteration/biomarker-positive primary CNS tumors at baseline and alteration/biomarker-positive advanced or metastatic neuroblastoma
? To evaluate the efficacy of study treatment in subgroup of patients with advanced or metastatic solid tumors that are alteration/biomarker-positive solid tumors with CNS metastases at baseline
? To evaluate the impact of study treatment on PROs of function and symptoms in patients with alteration/biomarker-positive advanced or metastatic solid tumors
? To evaluate the safety and tolerability of study treatment in patients with alteration/biomarker-positive solid tumors
? To characterize the pharmacokinetics of study treatment (and metabolite[s] if applicable)
? To evaluate the immune response to study treatment and potential effects of ADAs
;Primary end point(s): 1.IRC-assessed ORR based on confirmed (>= 4 weeks after initial documentation of response) objective response (per RECIST v1.1);Timepoint(s) of evaluation of this end point: 1. Approximately 8 years

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): 1. IRC-assessed DOR, CBR, and PFS per RECIST v1.1
2. 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. OS
5. Cohorts A, B, C, D, I, J, and K: IRC-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
6. Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
7. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, and N: IRC-assessed ORR, DOR, CBR, and PFS per INRC
8. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, and N: INV-assessed ORR, DOR, CBR, and PFS per INRC
9. Cohorts A, B, C, D, I, J, and K: IRC-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1
10. Cohorts A, B, C, D, I, J, and K: INV-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS per RECIST v1.1
11. Descriptive endpoint of 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 EORTC QLQ-C30
12. Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC IL71
13. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), including serious adverse events
14. Concentration of study treatment at specified timepoints
15. Incidence of ADAs during the study relative to the prevalence of ADAs at baseline
16. Relationship between ADA status and efficacy, safety, or pharmacokinetic endpoints
17. Cohort A, B and K: for pediatric patients - evaluate the acceptability and palatability of pralsetinib and Entrectinib with Acceptability Survey scores on Day 1 of Cycle 1
;Timepoint(s) of evaluation of this end point: 1-16. Approximately 8 years
17. Day 1 of Cycle 1

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, 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
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