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New treatment option for Mesothelioma
Official title Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
ClinicalTrials.gov ID: NCT05932199
What this study is testing
What is Durvalumab / tremelimumab?
Durvalumab / tremelimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mesothelioma.
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
- Objectives: The investigators will test whether combination of chemoimmunotherapy or dual agent immunotherapy alone improves efficacy for patients with MPM. Primary Objectives: The primary objective is to test whether the combination of platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves recurrence-free survival for patients with resectable MPM compared to historical, published data for surgery with chemotherapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- Which group you join is decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- Potentially Surgically resectable MPM. Computed tomography (CT) and positron emission tomography (PET) without disease beyond ipsilateral hemithorax...
- Any MPM histology (epithelial, mixed, sarcomatoid)
- N0 or N1 nodal disease, as present on preoperative chest CT and/or PET/CT
- N2 nodal disease.
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
You likely can't join if
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) or previous enrollment or...
- Participation in another clinical study with an investigational product during the last 3 months.
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor...
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction.
- Current or prior use of immunosuppressive medication within 28 days before the infusion with durvalumab or durvalumab + tremelimumab with the...
See the full eligibility criteria
Who can join
- Potentially Surgically resectable MPM. Computed tomography (CT) and positron emission tomography (PET) without disease beyond ipsilateral hemithorax. CT and PET scan without obvious invasion through the chest wall or...
- Any MPM histology (epithelial, mixed, sarcomatoid)
- N0 or N1 nodal disease, as present on preoperative chest CT and/or PET/CT
- N2 nodal disease.
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age \> 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (\> 1500 per mm3); Platelet count ≥ 100 × 109/L (\>100,000 per mm3); Serum bilirubin ≤...
- Female people must either be of non-reproductive potential (i.e., post-menopausal by history: ≥60 years old and no menses for \>1 year without an alternative medical cause; OR history of hysterectomy, OR history of...
- The subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
- Weight \>30 Kg
What rules you out
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) or previous enrollment or randomization in the present study.
- Participation in another clinical study with an investigational product during the last 3 months.
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigational agent) \<28 days
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction.
- Current or prior use of immunosuppressive medication within 28 days before the infusion with durvalumab or durvalumab + tremelimumab with the exceptions of intranasal and inhaled corticosteroids or systemic...
- Any unresolved toxicity (\>CTCAE grade 2) from previous anti-cancer therapy from diseases other than MPM.
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \>Grade 1 for disease other than MPM.
- Known auto-immune conditions requiring systemic immune suppression therapy other than prednisone \< 10 mg daily (or equivalent).
- History of interstitial pneumonitis of autoimmune etiology (including immune checkpoint pneumonitis) which has been symptomatic and/or treatment in the past. Any evidence of current ILD or pneumonitis or a prior history...
- History of primary immunodeficiency.
- History of allogeneic organ transplant.
- Intolerance of anti- PD-1/PD-L1 or CTLA-4 axis drug(s), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other...
- Concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study, including impaired heart function or clinically significant heart disease.
- A concurrent diagnosis of a separate malignancy is allowed if clinically stable and does not require tumor-directed therapy.
- Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS), hepatitis C virus (allowed if received curative therapy), acute or chronic active hepatitis B infection, or other serious chronic...
- Current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment on day 1 of study drug. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection...
- History of leptomeningeal carcinomatosis.
- Receipt of live attenuated vaccination within 30 days prior to receiving durvalumab or + tremelimumab.
- Female people who are pregnant, breastfeeding, or male or female people of reproductive potential who are not employing an effective method of birth control.
- Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study treatment or interpretation of subject safety or study results.
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
- people with uncontrolled seizures.
- No tissue is obtainable at the time of thoracoscopy.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
- Houston, Texas, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States; Houston, Texas, United States. 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.