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Compares treatment options for Mesotheliomas Pleural
Official title Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
ClinicalTrials.gov ID: NCT04996017
What this study is testing
What is Atezolizumab 1200 mg in 20 ML Injection?
Atezolizumab 1200 mg in 20 ML Injection is an investigational medicine, being studied as a potential treatment for mesotheliomas pleural.
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
- This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed Consent Form
- Age ≥ 18 years on day of signing informed consent
- Histologically confirmed malignant pleural mesothelioma
- Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed
- Absence of measurable or non-measurable disease assessed with CT scan after surgery
You likely can't join if
- Patient with macroscopic residual disease after surgery, evaluated with CT scan
- after surgery or adjuvant therapy
- people with active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune...
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ...
- Active infection requiring systemic therapy
- Patient with positive result to Human Immunodeficiency Virus (HIV) (HIV 1/2
See the full eligibility criteria
Who can join
- Signed informed Consent Form
- Age ≥ 18 years on day of signing informed consent
- Histologically confirmed malignant pleural mesothelioma
- Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed
- Absence of measurable or non-measurable disease assessed with CT scan after surgery
- Patients must have received at least no 4 cycles of platinum/pemetrexed
- perioperative chemotherapy as per local practice (neoadjuvant or adjuvant or both). Less than 4 cycles of chemotherapy are allowed for clinical decisions \- In patients previously treated with neoadjuvant chemotherapy...
- should occur within 50 days from surgical resection. \- In patients treated with adjuvant chemotherapy, randomization should occur
- within 30 ±7 days from last dose of adjuvant treatment.
- Performance status of 0-1 on the ECOG Performance Scale
- Availability of a representative tumor specimen for exploratory biomarker research (see Section 4.5.6 for information on tumor specimens) A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block...
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ³ 1.5 ´ 109/L (1500/mL) without granulocyte...
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Women must remain abstinent or use contraceptive methods with a failure...
What rules you out
- Patient with macroscopic residual disease after surgery, evaluated with CT scan
- after surgery or adjuvant therapy
- people with active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring...
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Active infection requiring systemic therapy
- Patient with positive result to Human Immunodeficiency Virus (HIV) (HIV 1/2
- antibodies) test
- Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
- obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
- active pneumonitis on screening chest computed tomography (CT) scan. NOTE:
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Known active tuberculosis
- Significant cardiovascular disease (such as New York Heart Association Class II or
- greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable
- angina
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of
- study treatment, or anticipation of need for a major surgical procedure during the
- study
- Severe infection within 4 weeks prior to initiation of study treatment, including, but
- not limited to, hospitalization for complications of infection, bacteremia, or severe
- pneumonia
- Prior allogeneic stem cell or solid organ transplantation
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of...
- Treatment with investigational therapy within 28 days prior to initiation of study
- treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study...
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents) within 2 weeks prior to initiation...
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for...
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- 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
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment
- Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Meldola, ITAòY, Italy
- Alessandria, Italy
- Bari, Italy
- Catania, Italy
- Chieti, Italy
- Ferrara, Italy
- Genova, Italy
- Mestre, Italy
- Modena, Italy
- Naples, Italy
- Orbassano, Italy
- Padova, Italy
- Parma, Italy
- Pavia, Italy
- Reggio Emilia, Italy
- Roma, Italy
- Rozzano, Italy
- Taranto, Italy
- Trieste, Italy
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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meldola, ITAòY, Italy; Alessandria, Italy; Bari, Italy; Catania, Italy; Chieti, Italy; Ferrara, Italy and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.