Solid tumors MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
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: RO55
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 50%; Participants aged = 50% ? For participants aged >= 18 and = 8 weeks ? Ability to comply with the study protocol, in the investigator's judgment ? For female participants of childbearing potential: Negative serum pregnancy test =65 years) yes F.1.3.1 Number of subjects for this age range 195
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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/biomarkerpositive 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: Approximately 8 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, CNSCBR, and CNS-PFS per RANO 6. Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNSCBR, 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, ICCBR, 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;Timepoint(s) of evaluation of this end point: 1-16. Approximately 8 years 17. Day 1 of Cycle 1 | — |
Countries
Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed