Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05001880

Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

66

Participants Needed

40

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with malignant peritoneal mesothelioma confirmed by tissue examination
  • No prior treatment for peritoneal mesothelioma
  • Measurable disease according to RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Leukocyte count of at least 2,500/mm^3
  • Absolute neutrophil count of at least 1,500/mm^3
  • Platelet count of at least 100,000/mm^3
  • Creatinine clearance of 45 mL/min/1.73 m^2 or higher if creatinine levels are above normal
  • Total bilirubin at or below 1.5 times the upper limit of normal
  • AST and ALT at or below 3 times the upper limit of normal
  • Urine protein/creatinine ratio less than 1 or urine protein 1+ or less
  • Women and men of reproductive potential must agree to use effective birth control during the study
  • Negative pregnancy test within 28 days before registration for women of childbearing potential
  • Patients with HIV on effective treatment with undetectable viral load within 6 months
  • Patients with chronic hepatitis B must have undetectable viral load if on therapy
  • Patients with hepatitis C must be cured or have undetectable viral load if on treatment
  • Patients with controlled autoimmune hypothyroidism on hormone replacement
  • Patients with controlled type 1 diabetes on insulin are eligible
  • Patients with well-controlled eczema, psoriasis, lichen simplex chronicus, or vitiligo affecting less than 10% of body surface area, requiring only low-potency topical corticosteroids
  • No active or history of autoimmune disease or immune deficiency except as noted
  • No prior systemic therapy for peritoneal mesothelioma
  • No concurrent radiotherapy allowed
Not Eligible

You will not qualify if you...

  • Psychiatric illness preventing informed consent
  • Uncontrolled infections, diabetes, or cardiac disease making treatment unsafe
  • Pregnant or nursing women
  • History of well-differentiated papillary or multicystic mesothelioma variants
  • Active second malignancy except non-melanoma skin cancers or cervical carcinoma in situ; must be disease-free for at least 3 years if previously treated
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or active pneumonitis on chest CT
  • Prior allogeneic stem cell or organ transplantation
  • Untreated or unstable central nervous system metastases
  • Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy
  • Significant cardiovascular disease including recent stroke, heart attack, unstable angina, heart failure (NYHA grade II or higher), or serious arrhythmia
  • Significant vascular disease such as recent aortic aneurysm repair or arterial thrombosis
  • History of severe venous thromboembolism
  • Central nervous system disease unrelated to cancer unless adequately treated
  • Recent history of hemoptysis (bright red blood coughing) within 1 month
  • Inherited bleeding disorders or significant coagulopathy
  • Major surgery or significant trauma within 28 days prior to treatment start
  • Minor surgery (except vascular access device placement) within 7 days prior to treatment
  • Active infection requiring intravenous antibiotics at treatment start
  • History of abdominal fistula, gastrointestinal perforation, abscess, or active GI bleeding within 6 months
  • Serious non-healing wounds, active ulcers, or untreated bone fractures
  • Other malignancy within 5 years except localized cancer in situ
  • Use of NSAIDs around pemetrexed administration if creatinine clearance is between 45 and 79 mL/min
  • Use or anticipated need for immunosuppressive medications within 2 weeks prior to treatment except specified low-dose or short-term exceptions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States, 85054

Suspended

2

Alliance for Clinical Trials in Oncology

Chicago, Illinois, United States, 60606

Actively Recruiting

3

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

4

Carle at The Riverfront

Danville, Illinois, United States, 61832

Actively Recruiting

5

Carle Physician Group-Effingham

Effingham, Illinois, United States, 62401

Actively Recruiting

6

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States, 61938

Actively Recruiting

7

Carle Cancer Center

Urbana, Illinois, United States, 61801

Actively Recruiting

8

The Carle Foundation Hospital

Urbana, Illinois, United States, 61801

Actively Recruiting

9

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Active, Not Recruiting

10

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States, 56601

Actively Recruiting

11

Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

12

Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

Actively Recruiting

13

Unity Hospital

Fridley, Minnesota, United States, 55432

Active, Not Recruiting

14

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

15

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

16

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States, 55416

Actively Recruiting

17

Regions Hospital

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

18

United Hospital

Saint Paul, Minnesota, United States, 55102

Actively Recruiting

19

Rice Memorial Hospital

Willmar, Minnesota, United States, 56201

Actively Recruiting

20

Sanford Cancer Center Worthington

Worthington, Minnesota, United States, 56187

Actively Recruiting

21

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States, 58501

Actively Recruiting

22

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Actively Recruiting

23

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58122

Actively Recruiting

24

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

25

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

26

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

27

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States, 57104

Actively Recruiting

28

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117-5134

Actively Recruiting

29

MD Anderson in The Woodlands

Conroe, Texas, United States, 77384

Actively Recruiting

30

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

31

MD Anderson West Houston

Houston, Texas, United States, 77079

Actively Recruiting

32

MD Anderson League City

League City, Texas, United States, 77573

Actively Recruiting

33

MD Anderson in Sugar Land

Sugar Land, Texas, United States, 77478

Actively Recruiting

34

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States, 54911

Actively Recruiting

35

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States, 54701

Actively Recruiting

36

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States, 54449

Actively Recruiting

37

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States, 54548

Actively Recruiting

38

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States, 54868

Actively Recruiting

39

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States, 54482

Actively Recruiting

40

Marshfield Medical Center - Weston

Weston, Wisconsin, United States, 54476

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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