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RecruitingNCT05001880Updated Sep 30, 2026

Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma

A Phase 2 interventional study of Atezolizumab and Bevacizumab in Peritoneal Malignant Mesothelioma, sponsored by National Cancer Institute (NCI). Recruiting at 40 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine whether frontline treatment with carboplatin, pemetrexed, bevacizumab and atezolizumab results in a superior best response rate than carboplatin, pemetrexed and bevacizumab in patients with peritoneal mesothelioma as determined by Response Evaluation Criteria in Solid Tumors (RECIST).

SECONDARY OBJECTIVES:

I. To determine the safety, major pathologic response rates, and completeness of cytoreduction of patients treated with neoadjuvant carboplatin, pemetrexed, bevacizumab and atezolizumab or carboplatin, pemetrexed and bevacizumab.

II. To determine the safety of patients treated with palliative carboplatin, pemetrexed, bevacizumab and atezolizumab or carboplatin, pemetrexed and bevacizumab.

III. To determine whether frontline treatment with carboplatin, pemetrexed, bevacizumab and atezolizumab results in a superior metabolic response rate than carboplatin, pemetrexed and bevacizumab as determined by Positron Emission Tomography (PET) Response Criteria in Solid Tumors.

IV. Explore the value that analysis of secondary computed tomography (CT) findings and quantitative fludeoxyglucose F-18 (FDG)-PET imaging adds to prognostic information and response assessment in this disease.

V. Determine the number of patients who were deemed to have unresectable disease who are able to undergo surgery following treatment with carboplatin, pemetrexed, bevacizumab and atezolizumab or carboplatin, pemetrexed and bevacizumab due to dramatic response.

VI. To compare the progression-free survival and overall survival between arms. VII. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

EXPLORATORY OBJECTIVE:

I. To determine whether blood-based biomarkers including our recently described cell-free chromosomal junctions, soluble mesothelin-related peptides and megakaryocyte potentiating factor correlate with clinical outcomes data (i.e. overall survival [OS], progression-free survival [PFS], recurrence, response, etc.).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes, bevacizumab IV, carboplatin IV, and pemetrexed IV on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients then undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Patients not eligible for surgery OR patients for whom surgery was aborted, insufficient or lacking cytoreductive intent may receive atezolizumab IV over 30-60 minutes and bevacizumab IV on day 1 of each maintenance therapy cycle. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bevacizumab IV, carboplatin IV, and pemetrexed IV on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients then undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery OR patients for whom surgery was aborted, insufficient or lacking cytoreductive intent may receive bevacizumab IV with or without atezolizumab IV over 30-60 minutes on day 1 of each maintenance therapy cycle at the discretion of the investigator. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo CT scan, PET scan, and collection of blood and tissue samples throughout the study.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

02

Conditions studied

  • Peritoneal Malignant Mesothelioma
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
    • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study

  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

    • Rash must cover \< 10% of body surface area
    • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
    • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • No prior allogeneic stem cell or solid organ transplantation
  • Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) with systemic steroids tapered to a physiologic dose (10 mg or prednisone equivalent or less)
  • Patients who have received live attenuated vaccines within 30 days of the first dose of trial treatment are eligible at the discretion of the investigator. All seasonal influenza vaccines and vaccines intended to prevent SARS-CoV-2 and coronavirus disease 2019 (COVID-19) are allowed
  • No history of inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No clinically significant cardiovascular disease, such as cerebrovascular accidents within 12 months prior to randomization, myocardial infarction within 12 months prior to randomization, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with study treatment
  • No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization
  • No history of grade >= 4 venous thromboembolism
  • No history or evidence upon physical or neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy
  • No history of grade >= 2 hemoptysis (defined as >= 2.5 mL of bright red blood per episode) within 1 month prior to screening
  • No history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
  • No major surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment (diagnostic laparoscopy is allowed as part of diagnosing peritoneal mesothelioma)
  • No core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to initiation of study treatment
  • Placement of a vascular access device should be at least 2 days prior to initiation of study treatment
  • No active infection requiring IV antibiotics at the time of initiation of study treatment
  • No history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization
  • No serious, non-healing wound, active ulcer, or untreated bone fracture
  • No other malignancy within 5 years prior to randomization, except for localized cancer in situ, such as basal or squamous cell skin cancer
  • Patients with a creatinine clearance between 45 and 79 mL/min should not use ibuprofen or other nonsteroidal anti-inflammatory drug (NSAIDs) for 2 days before, the day of, and 2 days following pemetrexed administration

  • No treatment with immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:

    • Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) may be eligible for the study
    • Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Arm I (carboplatin, pemetrexed, bevacizumab, atezolizumab)

    Patients receive atezolizumab IV over 30-60 minutes, bevacizumab IV, carboplatin IV, and pemetrexed IV on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients then undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery OR patients for whom surgery was aborted, insufficient or lacking cytoreductive intent may receive atezolizumab IV over 30-60 minutes and bevacizumab IV on day 1 of each maintenance therapy cycle. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan, PET scan, and collection of blood and tissue samples throughout the study.

    Biological: Atezolizumab · Biological: Bevacizumab · Procedure: Biospecimen Collection · Drug: Carboplatin · Procedure: Computed Tomography · Procedure: Cytoreductive Surgery · Drug: Hyperthermic Intraperitoneal Chemotherapy · Drug: Pemetrexed Disodium · Procedure: Positron Emission Tomography

  • Active comparator
    Arm II (carboplatin, pemetrexed, bevacizumab)

    Patients receive bevacizumab IV, carboplatin IV, and pemetrexed IV on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients then undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery OR patients for whom surgery was aborted, insufficient or lacking cytoreductive intent may receive bevacizumab IV with or without atezolizumab IV over 30-60 minutes on day 1 of each maintenance therapy cycle at the discretion of the investigator. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan, PET scan, and collection of blood and tissue samples throughout the study.

    Biological: Bevacizumab · Procedure: Biospecimen Collection · Drug: Carboplatin · Procedure: Computed Tomography · Procedure: Cytoreductive Surgery · Drug: Hyperthermic Intraperitoneal Chemotherapy · Drug: Pemetrexed Disodium · Procedure: Positron Emission Tomography

Interventions

  • BiologicalAtezolizumab

    Given IV

    Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

  • BiologicalBevacizumab

    Given IV

    Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avegra, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-aveg, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-byva, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-nwgd, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, Byvasda, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, IBI 305, IBI-305, IBI305, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Jobevne, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

  • ProcedureBiospecimen Collection

    Undergo blood and tissue sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • DrugCarboplatin

    Given IV

    Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • ProcedureCytoreductive Surgery

    Undergo surgery

    Also known as: Cytoreduction

  • DrugHyperthermic Intraperitoneal Chemotherapy

    Undergo HIPEC

    Also known as: HIPEC

  • DrugPemetrexed Disodium

    Given IV

    Also known as: Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

  • ProcedurePositron Emission Tomography

    Undergo PET scan

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

06

What researchers measure

Primary outcomes

  1. Response rate

    Will be compared between arms.

    Time frame: Up to 4 years after study activation

Secondary outcomes

  1. Major pathologic response rate

    The proportion of patients with a pathologic response will be calculated and compared between arms and 95% confidence intervals reported. The chi-square test will be used to compare the rates between arms.

    Time frame: Up to 3 years

  2. Completeness of cytoreduction

    Will be estimated.

    Time frame: Up to 3 years

  3. Conversion rate to surgical resection among those not deemed to be surgical candidates

    Will estimate the conversion rate to surgical resection among those not deemed to be surgical candidates prior to treatment and provide the 95% confidence interval as well.

    Time frame: Up to 3 years

  4. Progression-free survival (PFS)

    Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.

    Time frame: From study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on Response Evaluation Criteria in Solid Tumors 1.1 criteria, assessed up to 3 years

  5. Overall survival

    Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.

    Time frame: From study entry to death from any cause, assessed up to 3 years

  6. Incidence of adverse events

    The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.

    Time frame: Up to 3 years

Other outcomes

  1. Soluble mesothelin-related peptides (SMRP) and megakaryocyte potentiating factor (MPF)

    Will assess the association between two continuous biomarkers, MPF and SMRP, and best response to treatment prior to surgery, defined as response (complete response/partial response) versus no response (stable disease/progressive disease). Two separate logistic regression models will be used, one for each biomarker, with response status as the binary outcome and MPF or SMRP as the independent variable. The significance of the association will be evaluated using the Wald test from each model at a significance level of 0.05. Each biomarker will be assessed for skewness via visual inspection of histograms. If MPF or SMRP values appear markedly non-normal, will apply a logarithmic transformation to reduce skewness. To address zero values, a constant of 0.1 will be added to all observations before log transformation. Will explore the association of MPF and SMRP with the primary and secondary endpoints with and without accounting for treatment arm effects.

    Time frame: Up to 3 years

07

Study locations

37 of 40 sites recruiting
  • Mayo Clinic Hospital in Arizona
    Phoenix, Arizona 85054, United States
    Suspended
  • Alliance for Clinical Trials in Oncology
    Chicago, Illinois 60606, United States
    Recruiting
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
    Recruiting
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Suparna Mantha · Principal investigator
    Recruiting
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Suparna Mantha · Principal investigator
    Recruiting
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Suparna Mantha · Principal investigator
    Recruiting
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Suparna Mantha · Principal investigator
    Recruiting
  • The Carle Foundation Hospital
    Urbana, Illinois 61801, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Suparna Mantha · Principal investigator
    Recruiting
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
    Active, not recruiting
  • Sanford Joe Lueken Cancer Center
    Bemidji, Minnesota 56601, United States
    Recruiting
  • Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
    Recruiting
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
    Recruiting
  • Unity Hospital
    Fridley, Minnesota 55432, United States
    Active, not recruiting
  • Abbott-Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Site Public Contact · Contact · 855-776-0015
    • Aaron S. Mansfield · Principal investigator
    Recruiting
  • Park Nicollet Clinic - Saint Louis Park
    Saint Louis Park, Minnesota 55416, United States
    Recruiting
  • Regions Hospital
    Saint Paul, Minnesota 55101, United States
    Recruiting
  • United Hospital
    Saint Paul, Minnesota 55102, United States
    Recruiting
  • Rice Memorial Hospital
    Willmar, Minnesota 56201, United States
    Recruiting
  • Sanford Cancer Center Worthington
    Worthington, Minnesota 56187, United States
    • Site Public Contact · Contact · 605-312-3320
    • Daniel Almquist · Principal investigator
    Recruiting
  • Sanford Bismarck Medical Center
    Bismarck, North Dakota 58501, United States
    Recruiting
  • Sanford Broadway Medical Center
    Fargo, North Dakota 58122, United States
    Recruiting
  • Sanford Roger Maris Cancer Center
    Fargo, North Dakota 58122, United States
    Recruiting
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
    • Site Public Contact · Contact · Jamesline@osumc.edu · 800-293-5066
    • John L. Hays · Principal investigator
    Recruiting
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
    • Site Public Contact · Contact · 412-647-8073
    • Liza C. Villaruz · Principal investigator
    Recruiting
  • Sanford Cancer Center Oncology Clinic
    Sioux Falls, South Dakota 57104, United States
    Recruiting
  • Sanford USD Medical Center - Sioux Falls
    Sioux Falls, South Dakota 57117-5134, United States
    Recruiting
  • UT MD Anderson - The Woodlands
    Conroe, Texas 77384, United States
    Recruiting
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • UT MD Anderson - West Houston
    Houston, Texas 77079, United States
    Recruiting
  • UT MD Anderson - League City
    League City, Texas 77573, United States
    Recruiting
  • UT MD Anderson - Sugar Land
    Sugar Land, Texas 77478, United States
    Recruiting
  • ThedaCare Regional Cancer Center
    Appleton, Wisconsin 54911, United States
    Recruiting
  • Marshfield Medical Center-EC Cancer Center
    Eau Claire, Wisconsin 54701, United States
    Recruiting
  • Marshfield Medical Center-Marshfield
    Marshfield, Wisconsin 54449, United States
    Recruiting
  • Marshfield Medical Center - Minocqua
    Minocqua, Wisconsin 54548, United States
    Recruiting
  • Marshfield Medical Center-Rice Lake
    Rice Lake, Wisconsin 54868, United States
    Recruiting
  • Marshfield Medical Center-River Region at Stevens Point
    Stevens Point, Wisconsin 54482, United States
    Recruiting
  • Marshfield Medical Center - Weston
    Weston, Wisconsin 54476, United States
    Recruiting
08

References and documents

Publications

  • Steadman JA, Grotz TE. Principles of Surgical Management of Peritoneal Mesothelioma. J Natl Compr Canc Netw. 2023 Sep;21(9):981-986. doi: 10.6004/jnccn.2023.7055. PubMed 37673112 ↗

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05001880
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 12, 2021
Start date
Mar 22, 2022
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Aaron S Mansfield
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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