Locally Advanced Alveolar Soft Part Sarcoma study: Atezolizumab
Official title A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
ClinicalTrials.gov ID: NCT06066138
What this study is testing
What is Atezolizumab?
An investigational intravenous drug being studied for locally advanced alveolar soft part sarcoma. It is designed to block immune checkpoint proteins to help the immune system attack cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if smaller doses of atezolizumab can work as well as the usual dose but with fewer side effects.
- Who it's for
- Adults 18 years or older with locally advanced or metastatic alveolar soft part sarcoma, non‑small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, or melanoma.
- What's involved
- Participants receive atezolizumab through an IV, have blood tests, imaging scans, and a tumor tissue sample. The first two doses use the standard FDA dose; before the third dose the drug level in the blood is checked and the dose may be lowered. Blood levels are checked before each treatment for 16 weeks and then every 3 months.
- Time commitment
- The study can last up to 2 years, with regular visits for blood tests, imaging, and drug level checks.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they...
- Age \>=18 years old.
- Measurable disease per RECIST 1.1 criteria.
- ECOG performance status of 0-2.
- Absolute neutrophil count (ANC) \>=1,200/microliter
You likely can't join if
- Participants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study...
- Participants who have received immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications...
- Prior treatment with CD137 agonists
- Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.
- Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.
See the full eligibility criteria
Who can join
- Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab, either alone or in...
- Age \>=18 years old.
- Measurable disease per RECIST 1.1 criteria.
- ECOG performance status of 0-2.
- 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
- Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 5 months after atezolizumab treatment discontinuation.
- Participants with history of human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and have undetectable viral load.
- Participants with history of chronic hepatitis B virus (HBV) infection must be on suppressive therapy, if indicated, and have undetectable HBV viral load.
- Participants with history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load.
- Participants with history of treated brain metastases must have follow-up brain imaging after central nervous system (CNS)-directed therapy with no evidence of progression.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible.
- All participants must have the ability to understand and willingness to sign a written informed consent.
What rules you out
- Participants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation.
- Participants who have received 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...
- Prior treatment with CD137 agonists
- 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.
- Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.
- Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.
- Rash must cover less than 10% of body surface area (BSA)
- Disease is well controlled at screening and only requiring low potency topical steroids
- No acute exacerbations of underlying condition within 12 months prior to study treatment initiation (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin...
- Persisting toxicity related to prior therapy of Grade \>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 unless deemed not clinically significant or irreversible.
- Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- Active tuberculosis at screening
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on...
- Participants with significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident...
- Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in IOCBP performed at screening).
- Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.