This study is currently recruiting participants.
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)
Investigational Device(s)
Intervention(s)
Drug: Pembrolizumab Drug: Nivolumab
Supporting Site
National Cancer Institute
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.
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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 disease per RECIST 1.1 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)
-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 RECIST 1.1 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)
Principal Investigator
Referral Contact
For more information: