Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab for the Treatment of Locally Advanced or Metastatic Cancer
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
IRB19-1718 (primary)
NCI-2020-13885
Summary
This phase I trial compares the drug levels of the standard dosing schedule (of either nivolumab or pembrolizumab) to an extended interval dosing schedule. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The extended interval dosing schedule will give the same dose of drug but will wait double the amount of time to give the next dose compared to the standard dosing interval. The purpose of this study is to determine if drug levels in both groups are above a target level that represents the level at which the drug should most likely produce its effect. Giving nivolumab or pembrolizumab less often while maintaining the drug effectiveness may help patients save time and money.
Objectives
PRIMARY OBJECTIVE:
I. To assess the noninferiority of pharmacokinetic success, defined as drug trough levels above the target concentration of 1.5 ug/mL.
SECONDARY OBJECTIVE:
I. To compare the efficacy of extended interval and standard interval dosing, as based on time-to-treatment discontinuation (TTD) and overall survival (OS).
EXPLORATORY OBJECTIVE:
I. To expand upon previously published population pharmacokinetic and pharmacodynamic models for nivolumab and pembrolizumab.
OUTLINE: Patients are randomized to 1 of 2 dosing schedules (standard or extended).
STANDARD SCHEDULE DOSING:
ARM I: Patients receive nivolumab intravenously (IV) every 2 weeks (Q2W) or every 4 weeks (Q4W) in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
ARM II: Patients receive pembrolizumab IV every 3 weeks (Q3W) or every 6 weeks (Q6W) in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
EXTENDED INTERVAL DOSING:
ARM III: Patients receive nivolumab IV Q4W or every 8 weeks (Q8W) in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
ARM IV: Patients receive pembrolizumab IV Q6W in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Eligibility
- Voluntary written informed consent
- Patients with locally advanced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab
- >= 18 years old
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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