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Checkpoint Inhibitor
Extended vs Standard Dosing for Immunotherapy in Cancer
Phase 1
Recruiting
Led By Mark Ratain, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the levels of the drugs nivolumab and pembrolizumab in patients' blood when taken at the standard interval versus when taken less often.
Who is the study for?
This trial is for adults with measurable, advanced or metastatic cancer who are candidates for nivolumab or pembrolizumab treatment. It's not open to those who've had immune checkpoint inhibitors before, or plan to combine these drugs with ipilimumab or other anti-CTLA4 antibodies.Check my eligibility
What is being tested?
The study tests if nivolumab and pembrolizumab can be given less frequently than the current standard without affecting drug levels in the blood. Patients will receive either extended interval dosing or standard dosing of these medications.See study design
What are the potential side effects?
Nivolumab and pembrolizumab may cause immune-related reactions like skin rash, digestive issues, liver inflammation, lung problems (pneumonitis), hormone gland disorders (like thyroid dysfunction), and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Noninferiority margin of extended interval dosing compared to standard dosing
Secondary outcome measures
Compare the efficacy of extended interval and standard interval dosing
Trial Design
2Treatment groups
Experimental Treatment
Group I: standard interval dosingExperimental Treatment2 Interventions
Group II: extended interval dosingExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,013 Previous Clinical Trials
733,846 Total Patients Enrolled
Mark Ratain, MDPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
1,386 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not planning to receive both ipilimumab and nivolumab for my treatment.I am 18 years old or older.My doctor recommends nivolumab or pembrolizumab for my advanced cancer.My treatment plan includes ipilimumab with nivolumab or pembrolizumab.I have received treatments like immune checkpoint inhibitors or experimental antibody therapy before.
Research Study Groups:
This trial has the following groups:- Group 1: extended interval dosing
- Group 2: standard interval dosing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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