Metastatic Cancer
Conditions
Brief summary
A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.
Interventions
DRUGNivolumab Extended
For patients on extended interval dosing of nivolumab therapy will consist of 240mg IV once every 4 weeks or 480mg IV once every 8 weeks
DRUGPembrolizumab Extended
For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks
DRUGNivolumab Standard
For patients on standard schedule dosing of nivolumab, therapy will consist of 240mg IV once every 2 weeks or 480mg IV once every 4 weeks
DRUGPembrolizumab Standard
For patients on standard schedule dosing of pembrolizumab, therapy will consist of 200mg IV once every 3 weeks or 400mg IV once every 6 weeks
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab * 18 years old or older * Measurable disease per RECIST criteria
Exclusion criteria
* Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy. * Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal antibody in combination with either nivolumab or pembrolizumab. * Ipilimumab and nivolumab combination are not eligible for this trial. * (Note: Patients whose planned treatment is the combination of anti-PD-1 and tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of traditional cytotoxic chemotherapy and anti-PD-1 are eligible)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Noninferiority margin of extended interval dosing compared to standard dosing | 2 years | To assess the noninferiority of pharmacokinetic success, defined as drug trough levels above the target concentration of 1.5 µg/mL. Evaluable patients will be categorized as success or failure for this primary objective. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the efficacy of extended interval and standard interval dosing | 2 years | To compare the correlation of extended interval and standard interval dosing, as based on a combination of time-to-treatment discontinuation (TTD) and overall survival (OS). This secondary analysis will include all patients who received at least one dose |
Countries
United States
Contacts
Primary ContactPersonalized Cancer Care Consortium
Outcome results
None listed