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Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab for the Treatment of Locally Advanced or Metastatic Cancer
Trial Status: active
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.
Inclusion Criteria
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 or evaluable tumor burden (small, medium, high). Patients with nonmeasurable disease will be considered to have a small tumor burden for the purpose of the randomization strata
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)
Additional locations may be listed on ClinicalTrials.gov for NCT04295863.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
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.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
