Pediatric solid tumors for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) or intolerable MedDRA version: 18.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR
Conditions
Interventions
Product Name: MPDL3280A-RO5541267-F-03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: not yet defined
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration u
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age at study entry 16 years old) > 50 •Life expectancy >3 months Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Primary central nervous system (CNS) malignancy, untreated CNS metastases or treated but symptomatic CNS metastases •Prior allogeneic hematopoietic stem-cell transplant or prior solid-organ transplantation •Pregnant or lactating, or intending to become pregnant during the study •Treatment with a live vaccine or a live, attenuated vaccine within 4 weeks prior to initiation of study drug Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibodies •Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to initiation of study drug, or anticipated requirement for systemic immunosuppressive medications during the trial •Current treatment with therapeutic anticoagulants •Known active infection (excluding fungal infection of nail beds) within 28 days prior to initiation of study drug that has not completely resolved •History of autoimmune disease •History of severe asthma or presence of uncontrolled asthma at the time of screening evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of MPDL3280A, focusing on the nature, frequency, and severity of serious and non-serious adverse events, as well as effects on laboratory values, vital signs, or other safety biomarkers;Secondary Objective: To characterize the pharmacokinetics of MPDL3280A; To evaluate the immune response to MPDL3280A based on the incidence of anti-therapeutic antibodies (ATAs); to evaluate the anti-cancer activity of MPDL3280A;Primary end point(s): Safety and tolerability: All adverse events, all serious adverse events Pharmacokinetic: PK parameters are to include Cmax (Day 1 Cycle 1) and Cmin. ;Timepoint(s) of evaluation of this end point: PK collections are to include at least 2 samples on Day 1 of Cycle 1 (prior to infusion and one 30 minutes after the infusion). Pre -dose trough samples will be taken on Day 1 of cycles Cycles 2, 3, and 8, 12 and 16 (and every 8 cycles thereafter). In addition, a sample will be taken at the end of treatment and at least 90 days after last dose of study drug (washout) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: Anti therapeutic antibodies Efficacy: objective response rate and progression-free survival Exploratory endpoints for efficacy: Duration of objective response and overall survival Other exploratory endpoints: Determination of pharmacodynamic parameters of MPDL3280A, including PD-L1 status evaluation (archival tumor tissue; blood for PD evaluations will be drawn pretreatment and on day 1 of cycles 2, 3, 8, 12, 16 and every subsequent 8th cycle. In addition, blood for PD will be drawn at the time of study drug discontinuation and at least 90 days after the last dose of study drug (washout). ;Timepoint(s) of evaluation of this end point: Anti therapeutic antibodies - pretreatment, and on Day 1 of Cycles 2,3, and 8 12, 16 and every 8 cycles thereafter. A sample will also be drawn at the end of treatment and after washout. ORR and PFS -tumor assessment will be performed every two cycles [6 weeks] for the first 8 cycles; following cycle 8 tumor assessments will be done every 4 cycles. Duration of OR and OSS -tumor assessment will be performed every two cycles [6 weeks] for the first 8 cycles; following cycle 8 tumor assessments will be done every 4 cycles. | — |
Countries
Austria, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd
Outcome results
None listed