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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 below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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
1,004 Previous Clinical Trials
819,513 Total Patients Enrolled
Mark Ratain, MDPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
1,386 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04295863 — Phase 1
Cancer Research Study Groups: extended interval dosing, standard interval dosing
Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04295863 — Phase 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04295863 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies is Nivolumab Standard typically employed to alleviate?

"Nivolumab Standard can be used to treat microsatellite instability high, squamous cell carcinoma and unresectable melanoma."

Answered by AI

Has Nivolumab been accepted as a medicinal treatment by the FDA?

"Limited clinical data exists to support the efficacy and safety of Nivolumab Standard, thus our team rated it a 1 on their scale."

Answered by AI

What additional experiments have been conducted concerning the efficacy of Nivolumab Standard?

"As of today, 1632 clinical trials related to Nivolumab Standard are in progress. Of these investigations, 200 have reached phase 3 and the majority are located in Houston, Texas; however there is a total of 73059 possible sites where research may be conducted."

Answered by AI

Are there any openings available for participants in this experiment?

"Clinicaltrials.gov records indicate that this trial is proactively seeking participants, the first posting of which was made on June 25th 2020 and revised December 23rd 2021."

Answered by AI

How many participants are eligible to participate in this experiment?

"Indeed, according to the clinicaltrials.gov page, this trial is still accepting candidates. It was initially listed on June 25th 2020 and the most recent update occurred on December 23rd 2021. A total of 264 patients need to be recruited from 2 sites for participation in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
2020. "Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04295863.
~51 spots leftby Apr 2025
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