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NCT04295863 · ClinicalTrials.gov registry record · Phase 1
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
A Phase 1 study of Metastatic Cancer, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 264
- Enrollment target
- 2
- Study locations
NCT04295863: Recruiting Phase 1 study of Metastatic Cancer, sponsored by University of Chicago.
NCT04295863 is a Phase 1 study of Metastatic Cancer that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 264 participants, below the 441-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04295863, a Phase 1 study of Metastatic Cancer, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 264 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
To assess the noninferiority of pharmacokinetic success, defined as drug trough levels above the target concentration of 1.5 µg/mL. Evaluable patients will be categorized as success or failure for this primary objective.
Conditions Studied
Interventions
- DRUG Nivolumab Standard
- DRUG Pembrolizumab Standard
- DRUG Nivolumab Extended
- DRUG Pembrolizumab Extended
Study Locations (2)
Illinois
- University Of Chicago Medicine Comprehensive Cancer Center - Chicago
Wisconsin
- SSM Health Cancer Care - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2026-04-12 |
| Phase | Phase 1 |
What NCT04295863 shows while recruiting
NCT04295863 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 441-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Metastatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab Standard is the first listed.
NCT04295863 reports a single indexed study location in Illinois, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04295863 about?
NCT04295863 is a clinical study titled "Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers". 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...
What is the current status of trial NCT04295863?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 264 participants. The study started on 2020-06-25. Estimated completion is 2026-04-12.
What conditions does trial NCT04295863 study?
This clinical trial studies the following conditions: Metastatic Cancer.
What interventions are being tested in trial NCT04295863?
The interventions under investigation include: Nivolumab Standard (DRUG), Pembrolizumab Standard (DRUG), Nivolumab Extended (DRUG), Pembrolizumab Extended (DRUG).
Who is sponsoring clinical trial NCT04295863?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04295863 being conducted?
This trial has 2 study locations across Illinois, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04295863's enrollment target sits among peer trials
264 19th of 109 higher than 91 of 109 other Metastatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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