For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
Listing-Clinical Trial.gov – NCT03075527
Title– A Phase 2 Study of Durvalumab in Combination with Tremelimumab in Malignant Pleural Mesothelioma
Official Title– A Phase 2 Study of Durvalumab in Combination with Tremelimumab in Malignant Pleural Mesothelioma
Sponsor- Dana-Farber Cancer Institute
Astra Zeneca- collaborator
Location- Dana-Farber Cancer Institute Boston Massachusetts
Principle Investigator– Mark M Awad MD Dana-Farber Cancer Institute
Contact- Mark M. Awad, MD, PhD 617 632 3468 firstname.lastname@example.org
Patients will receive Durvalumab and tremelimumab both intravenous infusion once per day for every 28-day cycle. Participant s will receive tremelimumab for up to 4 cycles beginning with cycle 5 day 1. Patients will continue to receive durbalumab alon until clinical or radiological progression of disease
Tremelimumab blocks a receptor on immune cell that normally suppresses immune attack
Durvalumab is a drug that block a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cell
Number of Participants-40 Start Date April 10, 2017 Estimated Study Completion September 30, 2024
Purpose– The study is studying two immunotherapies as possible treatment for malignant pleural mesothelioma. Those drugs are Durvalumab and Tremelimumab. This is a phase 11 clinical trial
Eligibility Criteria– 18 Years and older
- Written informed consent prior to any study-specific procedures not considered part of routine medical care
- Histologically or cytological confirmed unresectable or medically inoperable malignant pleural mesothelioma
- Disease progression after treatment with at least one line of chemotherapy that include a first line platinum agent in combination with an anti-folate
- Participants must have measurable disease according to modified RECIST for pleural malignant mesothelioma. (Bone metastasis are not considered measurable) Prior radiation to the only site of measurable disease will make the participant ineligible unless the lesion has been demonstrated to grow after the completion of radiation therapy
- Participants must be willing to undergo a biopsy at the start of this study and an on –treatment biopsy if safe and feasible
- Participants must be at least 28 days from any major surgery
- ECOG performance status of 0 to 1
- Patients must t have adequate hematologic renal, organ and marrow function
- Must be 18 years and older
- Female and Males who are of childbearing ages must consent to one form of contraception from the time of screening and must continue until 180 days after last dose of investigational product.
- Patient is willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination including follow up
- previous treatment with an immune checkpoint inhibitor, 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, and are no longer taking corticosteroids and have been stable in imaging for at least 3 weeks
- Patient receiving corticosteroids doses greater than 10 mg per day for more than 14 days
- Patients receiving other systemic immunosuppressive drugs for more than 14 days
- Patients with a history of interstitial lung disease or pneumonitis that has required steroid administration
- 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 Patients with Grave’s disease or psoriasis not requiring systemic treatment within the past 2 years not excluded
- Inflammatory bowel disease or any other serious gastrointestinal condition associated with diarrhea
- History of primary immunodeficiency
- History of allogenic organ transplant
- History of hypersensitivity to tremelimumab, durvalumab or any excipient
- Know history of tuberculosis
- Receipt of live attenuated vaccination within 3o days prior to study entry or within 30 days of receiving durvalumab or trememlimumab
- Patient with history of secondary primary malignancy. If patient had curative malignancies with no recurrence within 5 years prior to study. Resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any type.
- Patient who have had chemotherapy, biologic therapy or investigational therapy with 21 days including bevizumab or radiotherapy with 7 days prior to entering the study or those who have not recovered from adverse events due to the administration of these agents
- If you have received any previous immunotherapy agent with adverse event at least or greater than grade 3
- You cannot receive any other investigational agents
- Active infections, gastritis symptomatic heart failure, hypertension, ( sbp greater than 160/100with medications)
- Unstable angina
- Cardiac arrhythmia
- Active bleeding diatheses
- Active peptic ulcer disease
- Psychiatric illness or social situations that would limit compliance with study
- Mean QT interval corrected for heart rate greater than 470 ms calculated from 3 electrocardiograms using Frederica’s correction
- Known history of HIV
- Acute or chronic hepatitis B or hepatitis C
- Pregnant women
- If involved with planning and/or conduct of Astra Zeneca staff and or staff at the study site
- If patient has had a pneumonectomy
- How the research Study is Designed to Work
Phase 11 clinical trial tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. The drugs durvalumab or tremelimumab are being studied to see how the drugs help as compared to the usual treatment for malignant 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 suppress immune attack.
Both of these drugs have been used for treatment of malignant mesothelioma, but the combination has not been tried in treatment in mesothelioma. They have been used successfully together in melanoma.
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating is able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to contact us with any questions.