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NCT06066138 · ClinicalTrials.gov registry record · Phase 1
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
A Phase 1 study of Metastatic Melanoma and Metastatic Non Small Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06066138: Recruiting Phase 1 study of Metastatic Melanoma and Metastatic Non Small Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
NCT06066138 is a Phase 1 study of Metastatic Melanoma and Metastatic Non Small Cell Lung Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06066138, a Phase 1 study of Metastatic Melanoma and Metastatic Non Small Cell Lung Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects. Objective: To test different doses and timing of atezolizumab for people with cancer. Eligibility: People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug. Design: Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor. Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care. The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later. For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change. Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months. Study treatment may last up to 2 years....
Primary Outcome
The fraction of participants that can be dosed with 840mg of atezolizumab at less frequent intervals while maintaining a trough PK concentration at or above 6 mg/mL
Conditions Studied
Interventions
- DRUG Atezolizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-11-04 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What NCT06066138 shows while recruiting
NCT06066138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (64% lower).
The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Atezolizumab is the first listed.
NCT06066138 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06066138 about?
NCT06066138 is a clinical study titled "A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing". Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers....
What is the current status of trial NCT06066138?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-11-04. Estimated completion is 2028-01-31.
What conditions does trial NCT06066138 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Non Small Cell Lung Cancer, Metastatic Hepatocellular Carcinoma, Locally Advanced Melanoma, Locally Advanced Hepatocellular Carcinoma.
What interventions are being tested in trial NCT06066138?
The interventions under investigation include: Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT06066138?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06066138 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06066138's enrollment target sits among peer trials
30 55th of 91 higher than 33 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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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