OncoMatch/Clinical Trials/NCT06066138
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Is NCT06066138 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Atezolizumab for locally advanced alveolar soft part sarcoma.
Treatment: Atezolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Small Cell Lung Cancer
Hepatocellular Carcinoma
Melanoma
Biomarker criteria
Allowed: PD-L1 (CD274) positive
for example, TMB-high, PDL-1 positive, or other disease states that respond to PD(L)-1 inhibitors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational agent not approved by FDA
received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation
Cannot have received: immunostimulatory agents (IFN-alpha, IFN-gamma, IL-2)
immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications, and any herbal medicines within 1 month prior to study treatment initiation
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint blockade therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, atezolizumab)
Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >=1,200/microliter; Hemoglobin >9.0 g/dL; Platelets >=75,000/microliter
Kidney function
Creatinine Clearance (CrCl) >=30 mL/min/1.73 m^2 (Cockcroft-Gault formula)
Liver function
Total bilirubin <= 1.5 mg/dL, except in participants with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dL; AST/ALT <=2.5 X institutional upper limit of normal (ULN)
Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count (ANC) >=1,200/microliter * Hemoglobin >9.0 g/dL * Platelets >=75,000/microliter * Total bilirubin <= 1.5 mg/dL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL * Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) <=2.5 X institutional upper limit of normal (ULN) * Creatinine Clearance (CrCl) >=30 mL/min/1.73 m^2 (calculated using the Cockcroft-Gault formula). * Serum albumin > 3 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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