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Immunotherapy boosts standard chemo in rare abdominal cancer trial

NCT ID NCT05001880

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 10 times

Summary

This phase 2 trial is testing whether adding the immunotherapy drug atezolizumab to standard chemotherapy (carboplatin, pemetrexed, and bevacizumab) works better than chemotherapy alone for peritoneal mesothelioma, a rare cancer of the abdominal lining. About 66 people will take part. The goal is to see if the combination shrinks tumors more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab (immunotherapy) added to standard chemotherapy (carboplatin, pemetrexed, bevacizumab)
What this could lead to
If it works, this could point toward a more effective treatment for peritoneal mesothelioma, potentially improving response rates and survival.
What could go wrong
This is a phase 2 trial with only 66 participants, so results are preliminary. Adding immunotherapy may increase side effects without clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

malignant peritoneal mesothelioma peritoneal mesothelioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peritoneal malignant mesothelioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    38 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Alliance for Clinical Trials in Oncology

    RECRUITING

    Chicago, Illinois, 60606, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Fairview Southdale Hospital

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Marshfield Medical Center - Minocqua

    RECRUITING

    Minocqua, Wisconsin, 54548, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Weston

    RECRUITING

    Weston, Wisconsin, 54476, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-EC Cancer Center

    RECRUITING

    Eau Claire, Wisconsin, 54701, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Rice Lake

    RECRUITING

    Rice Lake, Wisconsin, 54868, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-River Region at Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54482, United States

    Contact Email: •••••@•••••

  • Mayo Clinic Hospital in Arizona

    SUSPENDED

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mercy Hospital

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Park Nicollet Clinic - Saint Louis Park

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Rice Memorial Hospital

    RECRUITING

    Willmar, Minnesota, 56201, United States

  • Sanford Bismarck Medical Center

    RECRUITING

    Bismarck, North Dakota, 58501, United States

    Contact Email: •••••@•••••

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford Cancer Center Oncology Clinic

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

    Contact Email: •••••@•••••

  • Sanford Cancer Center Worthington

    RECRUITING

    Worthington, Minnesota, 56187, United States

  • Sanford Joe Lueken Cancer Center

    RECRUITING

    Bemidji, Minnesota, 56601, United States

    Contact Email: •••••@•••••

  • Sanford Roger Maris Cancer Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

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

    Contact Email: •••••@•••••

  • The Carle Foundation Hospital

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • ThedaCare Regional Cancer Center

    RECRUITING

    Appleton, Wisconsin, 54911, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UT MD Anderson - League City

    RECRUITING

    League City, Texas, 77573, United States

  • UT MD Anderson - Sugar Land

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • UT MD Anderson - The Woodlands

    RECRUITING

    Conroe, Texas, 77384, United States

  • UT MD Anderson - West Houston

    RECRUITING

    Houston, Texas, 77079, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • United Hospital

    RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • Unity Hospital

    ACTIVE_NOT_RECRUITING

    Fridley, Minnesota, 55432, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Kentucky/Markey Cancer Center

    ACTIVE_NOT_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.