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RECRUITING Phase 3

Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies

NCT07174453 · View on ClinicalTrials.gov ↗

Study Summary

Phase 3/4 open label, randomized two cohort study (2 arms in each cohort). It is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has more immune-related adverse events irAEs compared to lower dose (every 3 weeks Pembrolizumab 200mg dose and every 2 weeks Nivolumab 240mg dose).

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG Nivolumab

Study Locations (1)

Kansas

  • The University of Kansas Cancer Center — Westwood

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2025-10-07
Est. Completion 2029-10-01
Phase Phase 3

Sponsor

University of Kansas Medical Center

454 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07174453

The ClinicalTrials.gov registry entry for NCT07174453 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 454 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Solid Tumor Malignancies appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07174453 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07174453 about?

NCT07174453 is a clinical study titled "Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies". Phase 3/4 open label, randomized two cohort study (2 arms in each cohort). It is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has m...

What is the current status of trial NCT07174453?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2025-10-07. Estimated completion is 2029-10-01.

What conditions does trial NCT07174453 study?

This clinical trial studies the following conditions: Solid Tumor Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07174453?

The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07174453?

This trial is sponsored by University of Kansas Medical Center, which has 454 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07174453 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial