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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard interval dosing | Experimental |
| |
| extended interval dosing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab Standard | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Noninferiority margin of extended interval dosing compared to standard dosing | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the efficacy of extended interval and standard interval dosing | 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 | 2 years |
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Inclusion 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Personalized Cancer Care Consortium | Contact | 773.702.1220 | PhaseIICRA@medicine.bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Ratain, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Chicago Medicine Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pembrolizumab Standard | Drug | 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 |
|
| Nivolumab Extended | Drug | 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 |
|
| Pembrolizumab Extended | Drug | For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks |
|
| SSM Health Cancer Care | Recruiting | Madison | Wisconsin | 53717 | United States |
|