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

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:

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