Protocol Details
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
This study is currently recruiting participants.
Summary
Number | 000103-C |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required | No |
Population Exclusion(s) | Children |
Keywords | Keytruda;
Opdivo;
immune checkpoint inhibitors;
Pharmacokinetics |
Recruitment Keyword(s) | None |
Condition(s) | Cancer;
Neoplasms;
locally advanced cancer;
Metastatic Cancer |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | Drug: Pembrolizumab
Drug: Nivolumab
|
Supporting Site | National Cancer Institute |
Background:
Nivolumab and pembrolizumab are both used to treat cancer. Researchers want to learn if these drugs can be given less often than they are currently given and still be as effective. To do this, they will compare drug levels in the blood of a group taking either drug at the standard dosing intervals versus a group taking these drugs less often.
Objective:
To learn if nivolumab and pembrolizumab can be given less often than the currently approved schedule by the U.S. Food and Drug Administration (FDA).
Eligibility:
People ages 18 and older who have locally advanced or metastatic cancer and their doctor thinks they are a candidate for treatment with nivolumab or pembrolizumab.
Design:
Participants will be screened with a medical record review.
Participants will randomly be placed into 2 groups. Both groups will take either nivolumab or pembrolizumab. The drugs will be injected into a vein. One group will follow the regular FDA dosing schedule. The other group will follow an extended schedule. They will continue treatment until their disease progresses or they have severe side effects.
Participants will have many visits during the study. These will include blood tests and MRI and CT scans every 2-3 months. The scanners are machines that take pictures of the body. They will lie on a table that slides into the scanner. They will have a contrast agent injected into a vein. For the MRI, padding or a coil will be placed around their head.
Participants will be followed for 2 years after treatment ends.
Eligibility
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)
-Disease should not be amenable to curative-intent multimodal therapy nor should expected treatment have a predetermined number of nivolumab/pembrolizumab doses.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04295863