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

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-

P

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