PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
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. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient/physician decision, whichever occurs first. Randomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs >I). Patients will be radiologically evaluated after surgical procedure before starting therapy and then every 12 weeks for 24 months or until disease progression. At screening patients should be without macroscopic residual disease. Quality of life questionnaire will be administered to patient at baseline and every 12 weeks. During the study baseline tumor blocks will be centrally analyzed to determinate biological characteristics and gene expression.
NCT04996017 — Mesotheliomas Pleural
Status: Recruiting
http://inclinicaltrials.com/mesotheliomas-pleural/NCT04996017/
SBRT With Immunotherapy for Mesothelioma
This phase I trial studies the effect of stereotactic body radiation therapy and immunotherapy in treating patients with mesothelioma. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving stereotactic body radiation therapy and immunotherapy may improve the tumors response to the treatment and decrease side-effects.
NCT04926948 — Pleural Mesothelial Neoplasm
Status: Active, not recruiting
http://inclinicaltrials.com/pleural-mesothelial-neoplasm/NCT04926948/
Phase I Dose Escalation and Local Control Study of Pembrolizumab + Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma
The purpose of this study is to find out whether IMPRINT in combination with pembrolizumab is a safe treatment for people with malignant pleural mesothelioma (MPM).The highest dose of IMPRINT that causes few or mild side effects when given in combination with pembrolizumab will be found. Once the highest safe dose of IMPRINT is found, it will be tested in combination with pembrolizumab in future participants to see whether the combination may be an effective treatment for MPM.
NCT04897022 — Malignant Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04897022/
An Open-label, Multi-center, Phase I Study of Oral IAG933 in Adult Patients With Advanced Mesothelioma and Other Solid Tumors
The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.
NCT04857372 — Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/mesothelioma/NCT04857372/
Alvopem® (Pemetrexed) Safety Assessment in Patients With Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma
The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. No control groups were included in the study design. The primary objective of this study was safety assessment, including the incidence of AEs.
NCT04843007 — Non Small Cell Lung Cancer
Status: Completed
http://inclinicaltrials.com/non-small-cell-lung-cancer/NCT04843007/
Phase I Study of Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma
Background: Mesothelioma is a type of cancer. It originates in cells that line human body cavities. Most people have advanced disease when they are diagnosed. Researchers want to see if a combination of drugs can help. Objective: To find a safe dose of LMB-100 in combination with ipilimumab when LMB-100 is injected into tumors. Eligibility: Adults ages 18 and older with malignant pleural or peritoneal mesothelioma, that cannot be cured with surgery and has not responded to standard first-line treatments for mesothelioma. Design: Participants will be screened with: - Tumor biopsy or effusion, if needed - Medical history - Physical exam - Blood and urine tests - Imaging scans - Heart and lung function tests - Pregnancy test, if needed Some screening tests will be repeated during the study. Participants will get LMB-100 on Days 1 and 4 for up to 2 cycles. Each cycle lasts 21 days. They will stay in the hospital for about 8 days each time they get LMB-100. It will be injected into their tumor with needles. Participants will get ipilimumab through a tube that is put in a vein. It will be given on Day 2 of the first 2 cycles and Day 1 of the next 2 cycles. Participants will be assessed for how well they do daily activities. They will give blood and tissue samples for research. Participants will have a safety visit 4 to 6 weeks after the last dose of the study drugs. Then they will have scans every 6 weeks until their disease gets worse. If their tumor gets bigger, they will have phone, video, or email follow-ups every 12 weeks. Participants will be on this study for life....
NCT04840615 — Mesothelioma
Status: Terminated
http://inclinicaltrials.com/mesothelioma/NCT04840615/
Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma
Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).
NCT04823741 — Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/pleural-mesothelioma/NCT04823741/
Clinical Study of Neoadjuvant Anti-PD-1 Drug Toripalimab Combined With Chemotherapy in the Treatment of Locally Advanced Epithelial or Mixed Tissue Malignant Pleural Mesothelioma
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab, pemetrexed and carboplatin in the treatment of locally advanced malignant MPM in 15 newly diagnosed patients with locally advanced malignant MPM.
NCT04713761 — Malignant Pleural Mesothelioma
Status: Not yet recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04713761/
A Single-Arm, Open-Label, Phase I Trial to Assess the Safety of Genetically Engineered Autologous T Cells Targeting the Cell Surface Antigen Mesothelin With Cell-Intrinsic Checkpoint Inhibition in Patients With Mesothelioma
This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the safest dose to give to people with MPM. The researchers want to see what effects, if any, the study treatment has on people with this type of cancer. This study is the first time that an MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.
NCT04577326 — Malignant Pleural Mesothelioma (MPM)
Status: Recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma-mpm/NCT04577326/
Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma
This study will examine the safety and potential effectiveness of poly-ICLC directly injected into malignant pleural mesothelioma at the time of biopsy up to 21 days prior to the cancer being removed by the surgeon
NCT04525859 — Malignant Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04525859/