Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nivolumab Standard, Pembrolizumab Standard, Nivolumab Extended, Pembrolizumab Extended.
- Who it may be relevant to
- Registry conditions: Metastatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
Overview
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
- Drug Nivolumab 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 - Drug Pembrolizumab 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 - Drug Nivolumab 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 - Drug Pembrolizumab Extended
For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks
Primary outcome measures
- Noninferiority margin of extended interval dosing compared to standard dosing [Time frame: 2 years]
Secondary outcome measures (1)
- Compare the efficacy of extended interval and standard interval dosing [Time frame: 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University Of Chicago Medicine Comprehensive Cancer Center — Chicago
- SSM Health Cancer Care — Madison
Identifiers
NCT: NCT04295863 · IRB19-1718