Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma

Recruiting now · Phase 2

Conditions studied: Peritoneal Malignant Mesothelioma

In brief

This phase II trial compares the usual treatment alone (carboplatin, pemetrexed, and bevacizumab) to using immunotherapy (atezolizumab) plus the usual treatment in treating patients with peritoneal mesothelioma. The usual treatment consists of surgery or chemotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. 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. Giving atezolizumab with usual treatment may work better than usual treatment alone.

Key facts

Study ID

NCT05001880

Run by

National Cancer Institute (NCI)

People needed

66

Starts

2022-03-22

Expected to finish

2026-08-20

Last updated by the study team

2026-07-31

Who can join

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

You may qualify if…

• Physicians should consider whether any of the following may render the patient inappropriate for this protocol:
• Psychiatric illness which would prevent the patient from giving informed consent
• Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients with a "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years
• In addition:
• Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
• A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Histologically or cytologically confirmed malignant peritoneal mesothelioma for which there has been no prior treatment. Given the indolent nature of well-differentiated papillary mesothelioma and multicystic mesothelioma, patients with these variants are not eligible for participation
• Must have measurable disease per RECIST version (v) 1.1
• Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 28 days prior to registration is required
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Leukocytes >= 2,500/mm\^3
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Creatinine clearance >= 45 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN)
• Urine protein/creatinine (UPC) ratio < 1, or urine protein: =< 1+
• No prior systemic therapy for peritoneal mesothelioma is allowed. No concurrent radiotherapy is allowed
• No active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study

Where it is running

• Marshfield Medical Center - Weston — Weston, Wisconsin, United States (enrolling)
• Alliance for Clinical Trials in Oncology — Chicago, Illinois, United States (enrolling)
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)
• Carle at The Riverfront — Danville, Illinois, United States (enrolling)
• Carle Physician Group-Effingham — Effingham, Illinois, United States (enrolling)
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States (enrolling)
• Carle Cancer Center — Urbana, Illinois, United States (enrolling)
• The Carle Foundation Hospital — Urbana, Illinois, United States (enrolling)
• Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States (enrolling)
• Marshfield Medical Center - Minocqua — Minocqua, Wisconsin, United States (enrolling)
• Marshfield Medical Center-Rice Lake — Rice Lake, Wisconsin, United States (enrolling)
• Marshfield Medical Center-River Region at Stevens Point — Stevens Point, Wisconsin, United States (enrolling)
• Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States (enrolling)
• Mercy Hospital — Coon Rapids, Minnesota, United States (enrolling)
• Fairview Southdale Hospital — Edina, Minnesota, United States (enrolling)
• Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States (enrolling)
• Regions Hospital — Saint Paul, Minnesota, United States (enrolling)
• United Hospital — Saint Paul, Minnesota, United States (enrolling)
• Rice Memorial Hospital — Willmar, Minnesota, United States (enrolling)
• Sanford Cancer Center Worthington — Worthington, Minnesota, United States (enrolling)
• Sanford Bismarck Medical Center — Bismarck, North Dakota, United States (enrolling)
• Sanford Broadway Medical Center — Fargo, North Dakota, United States (enrolling)
• Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States (enrolling)

Full record on ClinicalTrials.gov

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