Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma

Running, not enrolling · Phase 1

Conditions studied: Biphasic Mesothelioma, Epithelioid Mesothelioma, Stage I Pleural Diffuse Malignant Mesothelioma AJCC v7, Stage IA Pleural Diffuse Malignant Mesothelioma AJCC v7, Stage IB Pleural Diffuse Malignant Mesothelioma AJCC v7, Stage II Pleural Diffuse Malignant Mesothelioma AJCC v7, Stage III Pleural Diffuse Malignant Mesothelioma AJCC v7

In brief

This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy works in treating patients with stage I-III pleural malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.

Key facts

Study ID

NCT03228537

Run by

National Cancer Institute (NCI)

People needed

28

Starts

2018-07-16

Expected to finish

2026-09-18

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• STEP 1: NEOADJUVANT
• Patient must have stage I-III malignant pleural mesothelioma that is deemed resectable and must be planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP)
• Patient must have epithelioid or biphasic histology (sarcomatoid histology is excluded); histologic diagnosis and typing of mesothelioma requires at least a core needle biopsy or surgical biopsy of the pleura via thoracoscopy and small thoracotomy; cytology only will not be regarded as sufficient for the diagnosis
• Patient must have computed tomography (CT) chest/abdomen/pelvis with contrast or fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT scan performed within 28 days prior to step 1 registration
• Patients must have non-measurable or measurable disease documented by CT or magnetic resonance imaging (MRI); the CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to step 1 registration; non-measurable disease must be assessed within 42 days prior to step 1 registration; all disease must be assessed and documented on the RECIST 1.1 and modified RECIST baseline tumor assessment form
• Patient must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound; at minimum, samples must be obtained from the mediastinal stations 4R, 7 (subcarinal), and 4L; this surgical staging must be performed within 42 days prior to step 1 registration; patient must be T1-3 and N0-N2 (single station)
• Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy within 28 days prior to step 1 registration to rule out peritoneal disease spread
• Patient must have consultation with a surgeon within 21 days prior to step 1 registration; the surgeon must confirm that the patient's disease is resectable by pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) and that the patient is an appropriate candidate for the surgical procedures
• Patient must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma
• Patient must have Zubrod performance status 0 or 1 documented within 28 days prior to step 1 registration
• Patients requiring hearing aids or reporting hearing loss must have audiogram performed within 28 days prior to step 1 registration
• Patient must have not had any major surgery or radiation within 28 days prior to step 1 registration; diagnostic thoracotomies and laparoscopies are not considered major surgeries
• Patients must not have any anticancer therapy or investigational agent within 28 days prior to step 1 registration
• Absolute neutrophil count (ANC) >= 1,500/mcl (documented within 28 days prior to step 1 registration)
• Hemoglobin >= 9 g/dl (documented within 28 days prior to step 1 registration)
• Platelets >= 100,000/mcl (documented within 28 days prior to step 1 registration)
• Creatinine =< 1.5 x upper limit of normal (ULN) (documented within 28 days prior to step 1 registration)
• Creatinine clearance >= 45 ml/min (documented within 28 days prior to step 1 registration)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to step 1 registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 28 days prior to step 1 registration)
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
• Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment; women of reproductive potential and men must have agreed to use an effective contraceptive method for the duration of study treatment and for 5 months (150 days) after the last dose of atezolizumab; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Patient must NOT have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Patient must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• Patients must not have severe infections within 28 days prior to step 1 registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

Where it is running

• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• OSF Saint Francis Radiation Oncology at Peoria Cancer Center — Peoria, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Illinois CancerCare-Peru — Peru, Illinois, United States
• Valley Radiation Oncology — Peru, Illinois, United States
• Illinois CancerCare-Princeton — Princeton, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Springfield Memorial Hospital — Springfield, Illinois, United States
• Southwest Illinois Health Services LLP — Swansea, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• The Carle Foundation Hospital — Urbana, Illinois, United States
• Rush-Copley Healthcare Center — Yorkville, Illinois, United States
• Mary Greeley Medical Center — Ames, Iowa, United States
• McFarland Clinic - Ames — Ames, Iowa, United States
• McFarland Clinic - Boone — Boone, Iowa, United States
• Mercy Cancer Center-West Lakes — Clive, Iowa, United States
• UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
• Alegent Health Mercy Hospital — Council Bluffs, Iowa, United States
• Greater Regional Medical Center — Creston, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
• McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
• OSF Saint Francis Radiation Oncology at Pekin — Pekin, Illinois, United States

Full record on ClinicalTrials.gov

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