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Immunotherapy combo before surgery shows promise for tough mesothelioma

NCT ID NCT05647265

Disease control Sponsor: Alliance for Clinical Trials in Oncology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This phase II trial is testing whether giving two immunotherapy drugs, nivolumab and ipilimumab, before surgery can help control sarcomatoid mesothelioma, a rare and aggressive cancer of the lung lining. The study will enroll 26 people with stage I to IIIa disease. The main goals are to see how many patients can successfully undergo surgery after immunotherapy and how long the cancer stays under control.

What this could mean

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

Active substance
nivolumab and ipilimumab (immunotherapy drugs)
What this could lead to
If successful, this approach could improve surgery rates and delay cancer progression for people with this aggressive mesothelioma type.
What could go wrong
This is a small, early-phase trial with only 26 participants. Immunotherapy can cause serious side effects, and the treatment may not work for everyone.

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 26 people

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

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Sarcomatoid or sarcomatoid-dominant (\> 50%) biphasic, pleural mesothelioma * Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition * Measurable disease or non-measurable disease as defined * No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint * No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.) * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 or Karnofsky \>= 60% * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Leukocytes \>= 2,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \>= 40 mL/min * Total bilirubin =\<1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN * Alkaline (alk) phosphatase (phos) =\< 3.0 x ULN * No active, known or suspected autoimmune disease except for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger * No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody * No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery * STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection * STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =\< 2 or Karnofsky \>= 60% * STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) \> 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) \> 35% * STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no more than 90 days after the last dose of neoadjuvant therapy Exclusion Criteria: * No patients deemed to be unresectable or poor surgical candidates * No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes * No patients with a history of symptomatic interstitial lung disease

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Conditions

The condition(s) this trial relates to.

pleural biphasic mesothelioma pleural sarcomatoid mesothelioma

As listed by the trial registrant

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

Pleural biphasic mesothelioma Pleural sarcomatoid 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

    122 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

  • Alaska Breast Care and Surgery LLC

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alaska Oncology and Hematology LLC

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alaska Women's Cancer Care

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    RECRUITING

    Las Vegas, Nevada, 89135, United States

    Contact Email: •••••@•••••

  • Anchorage Associates in Radiation Medicine

    RECRUITING

    Anchorage, Alaska, 98508, United States

  • Anchorage Radiation Therapy Center

    SUSPENDED

    Anchorage, Alaska, 99504, United States

  • Ann M Wierman MD LTD

    SUSPENDED

    Las Vegas, Nevada, 89128, United States

  • Bay Area Hospital

    RECRUITING

    Coos Bay, Oregon, 97420, United States

  • Beebe Health Campus

    ACTIVE_NOT_RECRUITING

    Rehoboth Beach, Delaware, 19971, United States

  • Beebe Medical Center

    ACTIVE_NOT_RECRUITING

    Lewes, Delaware, 19958, United States

  • Beebe South Coastal Health Campus

    ACTIVE_NOT_RECRUITING

    Millville, Delaware, 19967, United States

  • Cancer Care Northwest - Spokane South

    RECRUITING

    Spokane, Washington, 99202, United States

    Contact Email: •••••@•••••

  • Cancer Care Northwest-North Spokane

    RECRUITING

    Spokane, Washington, 99218, United States

    Contact Email: •••••@•••••

  • Cancer Care Northwest-Valley

    RECRUITING

    Spokane, Washington, 99216, United States

    Contact Email: •••••@•••••

  • Cancer and Blood Specialists-Henderson

    SUSPENDED

    Henderson, Nevada, 89052, 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: •••••@•••••

  • Carson Tahoe Regional Medical Center

    RECRUITING

    Carson City, Nevada, 89703, United States

    Contact Email: •••••@•••••

  • Christiana Care - Union Hospital

    ACTIVE_NOT_RECRUITING

    Elkton, Maryland, 21921, United States

  • Christiana Care Health System-Christiana Hospital

    ACTIVE_NOT_RECRUITING

    Newark, Delaware, 19718, United States

  • Christiana Care Health System-Concord Health Center

    ACTIVE_NOT_RECRUITING

    Chadds Ford, Pennsylvania, 19317, United States

  • Christiana Care Health System-Wilmington Hospital

    ACTIVE_NOT_RECRUITING

    Wilmington, Delaware, 19801, United States

  • Clackamas Radiation Oncology Center

    RECRUITING

    Clackamas, Oregon, 97015, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Las Vegas, Nevada, 89148, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada - Central Valley

    RECRUITING

    Las Vegas, Nevada, 89169, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada - Henderson

    RECRUITING

    Henderson, Nevada, 89052, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada - Northwest

    RECRUITING

    Las Vegas, Nevada, 89128, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada - Town Center

    RECRUITING

    Las Vegas, Nevada, 89144, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    RECRUITING

    Henderson, Nevada, 89052, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    RECRUITING

    Henderson, Nevada, 89074, United States

    Contact Email: •••••@•••••

  • Comprehensive Cancer Centers of Nevada-Summerlin

    RECRUITING

    Las Vegas, Nevada, 89144, United States

    Contact Email: •••••@•••••

  • Delaware Clinical and Laboratory Physicians PA

    ACTIVE_NOT_RECRUITING

    Newark, Delaware, 19713, United States

  • Duke Cancer Center Raleigh

    RECRUITING

    Raleigh, North Carolina, 27609, United States

    Contact Email: •••••@•••••

  • Duke Cancer Center Southpoint

    RECRUITING

    Durham, North Carolina, 27713, United States

    Contact Email: •••••@•••••

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Helen F Graham Cancer Center

    ACTIVE_NOT_RECRUITING

    Newark, Delaware, 19713, United States

  • Hope Cancer Care of Nevada

    RECRUITING

    Las Vegas, Nevada, 89103, United States

    Contact Email: •••••@•••••

  • Hope Cancer Care of Nevada-Pahrump

    RECRUITING

    Pahrump, Nevada, 89048, United States

    Contact Email: •••••@•••••

  • Kadlec Clinic Hematology and Oncology

    RECRUITING

    Kennewick, Washington, 99336, United States

    Contact Email: •••••@•••••

  • Katmai Oncology Group

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Kingman Regional Medical Center

    RECRUITING

    Kingman, Arizona, 86401, United States

    Contact Email: •••••@•••••

  • Las Vegas Cancer Center-Henderson

    SUSPENDED

    Henderson, Nevada, 89052, United States

  • Las Vegas Cancer Center-Medical Center

    SUSPENDED

    Las Vegas, Nevada, 89148-2405, United States

  • Las Vegas Prostate Cancer Center

    SUSPENDED

    Las Vegas, Nevada, 89113, United States

  • Las Vegas Urology - Cathedral Rock

    SUSPENDED

    Las Vegas, Nevada, 89128, United States

  • Las Vegas Urology - Green Valley

    SUSPENDED

    Henderson, Nevada, 89074, United States

  • Las Vegas Urology - Pebble

    SUSPENDED

    Henderson, Nevada, 89074, United States

  • Las Vegas Urology - Pecos

    SUSPENDED

    Las Vegas, Nevada, 89074, United States

  • Las Vegas Urology - Smoke Ranch

    SUSPENDED

    Las Vegas, Nevada, 89128, United States

  • Las Vegas Urology - Sunset

    SUSPENDED

    Las Vegas, Nevada, 89113, United States

  • Mayo Clinic Hospital in Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical Oncology Hematology Consultants PA

    ACTIVE_NOT_RECRUITING

    Newark, Delaware, 19713, United States

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    RECRUITING

    Yakima, Washington, 98902, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Glenview Outpatient Center

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwestern Medicine Grayslake Outpatient Center

    RECRUITING

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    RECRUITING

    Lake Forest, Illinois, 60045, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Oncology Las Vegas - Henderson

    RECRUITING

    Henderson, Nevada, 89074, United States

    Contact Email: •••••@•••••

  • Oncology Las Vegas - Tenaya

    RECRUITING

    Las Vegas, Nevada, 89128, United States

    Contact Email: •••••@•••••

  • OptumCare Cancer Care at Charleston

    RECRUITING

    Las Vegas, Nevada, 89102, United States

    Contact Email: •••••@•••••

  • OptumCare Cancer Care at Fort Apache

    RECRUITING

    Las Vegas, Nevada, 89183, United States

    Contact Email: •••••@•••••

  • OptumCare Cancer Care at MountainView

    RECRUITING

    Las Vegas, Nevada, 89128, United States

    Contact Email: •••••@•••••

  • Overlake Medical Center

    SUSPENDED

    Bellevue, Washington, 98004, United States

  • PCR Oncology

    RECRUITING

    Arroyo Grande, California, 93420, United States

    Contact Email: •••••@•••••

  • PeaceHealth Saint John Medical Center

    RECRUITING

    Longview, Washington, 98632, United States

  • PeaceHealth Saint Joseph Medical Center

    RECRUITING

    Bellingham, Washington, 98225, United States

  • PeaceHealth Southwest Medical Center

    RECRUITING

    Vancouver, Washington, 98664, United States

  • PeaceHealth United General Medical Center

    RECRUITING

    Sedro-Woolley, Washington, 98284, United States

  • Providence Alaska Medical Center

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Providence Cancer Institute Clackamas Clinic

    SUSPENDED

    Clackamas, Oregon, 97015, United States

  • Providence Hood River Memorial Hospital

    RECRUITING

    Hood River, Oregon, 97031, United States

    Contact Email: •••••@•••••

  • Providence Medical Foundation - Santa Rosa

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Providence Newberg Medical Center

    RECRUITING

    Newberg, Oregon, 97132, United States

    Contact Email: •••••@•••••

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Queen of The Valley

    RECRUITING

    Napa, California, 94558, United States

  • Providence Regional Cancer Partnership

    RECRUITING

    Everett, Washington, 98201, United States

  • Providence Regional Cancer System-Aberdeen

    RECRUITING

    Aberdeen, Washington, 98520, United States

  • Providence Regional Cancer System-Centralia

    RECRUITING

    Centralia, Washington, 98531, United States

  • Providence Regional Cancer System-Lacey

    RECRUITING

    Lacey, Washington, 98503, United States

  • Providence Regional Cancer System-Shelton

    SUSPENDED

    Shelton, Washington, 98584, United States

  • Providence Regional Cancer System-Yelm

    SUSPENDED

    Yelm, Washington, 98597, United States

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    RECRUITING

    Burbank, California, 91505, United States

  • Providence Saint Mary Regional Cancer Center

    RECRUITING

    Walla Walla, Washington, 99362, United States

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Providence Santa Rosa Memorial Hospital

    RECRUITING

    Santa Rosa, California, 95405, United States

  • Providence Willamette Falls Medical Center

    RECRUITING

    Oregon City, Oregon, 97045, United States

    Contact Email: •••••@•••••

  • Radiation Oncology Associates

    SUSPENDED

    Reno, Nevada, 89509, United States

  • Radiation Oncology Centers of Nevada Central

    RECRUITING

    Las Vegas, Nevada, 89106, United States

    Contact Email: •••••@•••••

  • Radiation Oncology Centers of Nevada Southeast

    RECRUITING

    Las Vegas, Nevada, 89119, United States

    Contact Email: •••••@•••••

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Rush-Copley Healthcare Center

    RECRUITING

    Yorkville, Illinois, 60560, United States

    Contact Email: •••••@•••••

  • Rush-Copley Medical Center

    RECRUITING

    Aurora, Illinois, 60504, United States

  • Saint Charles Health System

    RECRUITING

    Bend, Oregon, 97701, United States

  • Saint Charles Health System-Redmond

    RECRUITING

    Redmond, Oregon, 97756, United States

  • Saint Luke's Cancer Institute - Boise

    RECRUITING

    Boise, Idaho, 83712, United States

  • Saint Luke's Cancer Institute - Fruitland

    RECRUITING

    Fruitland, Idaho, 83619, United States

  • Saint Luke's Cancer Institute - Meridian

    RECRUITING

    Meridian, Idaho, 83642, United States

  • Saint Luke's Cancer Institute - Nampa

    RECRUITING

    Nampa, Idaho, 83687, United States

  • Saint Luke's Cancer Institute - Twin Falls

    RECRUITING

    Twin Falls, Idaho, 83301, United States

  • Saint Mary's Regional Medical Center

    RECRUITING

    Reno, Nevada, 89503, United States

    Contact Email: •••••@•••••

  • Saint Patrick Hospital - Community Hospital

    RECRUITING

    Missoula, Montana, 59802, United States

  • Skagit Regional Health Cancer Care Center

    RECRUITING

    Mount Vernon, Washington, 98274, United States

    Contact Email: •••••@•••••

  • Summerlin Hospital Medical Center

    RECRUITING

    Las Vegas, Nevada, 89144, United States

    Contact Email: •••••@•••••

  • Sunrise Hospital and Medical Center

    RECRUITING

    Las Vegas, Nevada, 89109, United States

    Contact Email: •••••@•••••

  • Swedish Cancer Institute-Edmonds

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Swedish Cancer Institute-Issaquah

    RECRUITING

    Issaquah, Washington, 98029, United States

  • Swedish Medical Center-Ballard Campus

    RECRUITING

    Seattle, Washington, 98107, United States

  • Swedish Medical Center-Cherry Hill

    RECRUITING

    Seattle, Washington, 98122-5711, United States

  • Swedish Medical Center-First Hill

    RECRUITING

    Seattle, Washington, 98122, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

    Contact Email: •••••@•••••

  • UT Southwestern Clinical Center at Richardson/Plano

    RECRUITING

    Richardson, Texas, 75080, United States

  • UT Southwestern Simmons Cancer Center - RedBird

    RECRUITING

    Dallas, Texas, 75237, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • University Cancer Center

    SUSPENDED

    Las Vegas, Nevada, 89169, United States

  • University Medical Center of Southern Nevada

    RECRUITING

    Las Vegas, Nevada, 89102, United States

    Contact Email: •••••@•••••

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Minnesota/Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Urology Specialists of Nevada - Central

    RECRUITING

    Las Vegas, Nevada, 89106, United States

    Contact Email: •••••@•••••

  • Urology Specialists of Nevada - Green Valley

    RECRUITING

    Henderson, Nevada, 89074, United States

    Contact Email: •••••@•••••

  • Urology Specialists of Nevada - Northwest

    RECRUITING

    Las Vegas, Nevada, 89128, United States

    Contact Email: •••••@•••••

  • Urology Specialists of Nevada - Southwest

    RECRUITING

    Las Vegas, Nevada, 89113, United States

    Contact Email: •••••@•••••

  • Valley Medical Center

    RECRUITING

    Renton, Washington, 98055, United States

    Contact Email: •••••@•••••

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