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This research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma.
The drugs involved in this study are:
Full description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab or tremelimumab as a treatment for any disease.
In this research study, the investigators are studying if the study drug can help your cancer compared to the usual approach to treating malignant pleural mesothelioma . Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells. Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. These two study drugs have been used alone for mesothelioma but the combination has not yet been tested for mesothelioma. These two drugs have been used for cancers such as melanoma and have been effective than using either drug alone.
Enrollment
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Inclusion criteria
Exclusion criteria
Previous treatment with an immune check-point inhibitors, CTLA-4, PD-1, or PD-L1, including prior treatment with either durvalumab or tremelimumab
Known central nervous system metastasis. Patients with known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease may be enrolled if they have been treated, are no longer taking corticosteroids, and have been stable on imaging for at least 3 weeks
Subjects currently receiving systemic corticosteroids above 10 mg per day for more than 14 days; subjects receiving other systemic immunosuppressive drugs for more than 14 days. Exceptions include: inhaled, intranasal, ophthalmic, and topical corticosteroids, local corticosteroid injections (e.g., intra-articular injections), and subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g. CT scan premedication)
Subjects with medical conditions that require the chronic use of systemic corticosteroids. Exceptions include: inhaled, intranasal, ophthalmic, and topical corticosteroids, local corticosteroid injections (e.g., intra-articular injections), and subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g. CT scan premedication)
Active or prior documented autoimmune disease within the past 2 years, including but not limited to systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's granulomatosis. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded.
Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, celiac disease, diverticulitis), or any other chronic, serious gastrointestinal condition associated with diarrhea. NOTE: Subjects with known diverticulosis are permitted to enroll.
History of interstitial lung disease or pneumonitis that has required steroid administration.
History of primary immunodeficiency
History of allogeneic organ transplant
History of hypersensitivity to tremelimumab, durvalumab, or any excipient
Known history of active tuberculosis
Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab
Participants with a history of a second primary malignancy. Exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 5 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any type.
Participants who have had chemotherapy, biologic therapy, or investigational therapy within 21 days (including bevacizumab) or radiotherapy within 7 days prior to entering the study or those who have not recovered from adverse events due to agents administered
Any history of a prior immune-related adverse event (irAE) at least or greater than grade 3 while receiving any previous immunotherapy agent.
Participants who are receiving any other investigational agents.
Uncontrolled intercurrent illness including, but not limited to:
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction
Known past or present medical history HIV-positive
Subjects with known acute or chronic hepatitis B or hepatitis C.
Pregnant women are excluded from this study because tremelimumab and durvalumab have unknown effects on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tremelimumab or durvalumab, breastfeeding women are also excluded. Female subjects of child bearing potential must have a negative serum pregnancy test obtained prior to trial registration.
Subjects who are involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Subjects who have undergone a pneumonectomy due to known potential for pulmonary toxicities and heightened risk for complications.
Primary purpose
Allocation
Interventional model
Masking
19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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