Recruiting
Phase 2

Immunotherapy

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT05647265

Conditions

Pleural Biphasic Mesothelioma

Pleural Sarcomatoid Mesothelioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab

Ipilimumab

Surgical Procedure

Computed Tomography

Magnetic Resonance Imaging

Study Details

Brief summary:

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Conditions

Pleural Biphasic Mesothelioma

Pleural Sarcomatoid Mesothelioma

Study ID

NCT05647265

Start date

Nov 27, 2024

Status verified date

Aug, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (nivolumab, ipilimumab, surgery)

Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.

Interventions

Nivolumab

Given IV

Ipilimumab

Given IV

Surgical Procedure

Undergo surgery

Computed Tomography

undergo CT

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET

Primary outcome measure

  • Surgery Rate [ Time Frame: immediately after the completion of neoadjuvant immunotherapy and surgery ]
  • Progression free survival (PFS) [ Time Frame: At 12 months after initiation of neoadjuvant immunotherapy ]

Central Contacts and Locations

Central contacts

Locations

Anchorage Associates in Radiation Medicine

Recruiting

Anchorage, Alaska, United States, 98508

Contacts

Principal Investigator:

Alison K. Conlin

Alaska Breast Care and Surgery LLC

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Alison K. Conlin

Alaska Oncology and Hematology LLC

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Alison K. Conlin

Alaska Women's Cancer Care

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Alison K. Conlin

Katmai Oncology Group

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Alison K. Conlin

Providence Alaska Medical Center

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Alison K. Conlin

Kingman Regional Medical Center

Recruiting

Kingman, Arizona, United States, 86401

Contacts

Principal Investigator:

John A. Ellerton

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Aaron S. Mansfield

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Aaron S. Mansfield

PCR Oncology

Recruiting

Arroyo Grande, California, United States, 93420

Contacts

Principal Investigator:

John A. Ellerton

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Recruiting

Burbank, California, United States, 91505

Contacts

Principal Investigator:

Alison K. Conlin

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Lyudmila A. Bazhenova

Providence Queen of The Valley

Recruiting

Napa, California, United States, 94558

Contacts

Site Public Contact

707-521-3830

Principal Investigator:

Alison K. Conlin

Providence Medical Foundation - Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

707-521-3830

Principal Investigator:

Alison K. Conlin

Providence Santa Rosa Memorial Hospital

Recruiting

Santa Rosa, California, United States, 95405

Contacts

Site Public Contact

707-521-3830

Principal Investigator:

Alison K. Conlin

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Aaron S. Mansfield

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Principal Investigator:

Alison K. Conlin

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Principal Investigator:

Alison K. Conlin

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Principal Investigator:

Alison K. Conlin

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Alison K. Conlin

Saint Luke's Cancer Institute - Twin Falls

Recruiting

Twin Falls, Idaho, United States, 83301

Contacts

Principal Investigator:

Alison K. Conlin

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Principal Investigator:

Tanmay Sahai

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Young Kwang Chae

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Hedy L. Kindler

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Tanmay Sahai

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Young Kwang Chae

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Tanmay Sahai

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Young Kwang Chae

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Tanmay Sahai

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Young Kwang Chae

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Tanmay Sahai

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Young Kwang Chae

Rush-Copley Healthcare Center

Recruiting

Yorkville, Illinois, United States, 60560

Contacts

Principal Investigator:

Tanmay Sahai

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Site Public Contact

612-624-2620

Principal Investigator:

Robert A. Kratzke

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Aaron S. Mansfield

Saint Patrick Hospital - Community Hospital

Recruiting

Missoula, Montana, United States, 59802

Contacts

Principal Investigator:

Alison K. Conlin

Carson Tahoe Regional Medical Center

Recruiting

Carson City, Nevada, United States, 89703

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada - Henderson

Recruiting

Henderson, Nevada, United States, 89052

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Recruiting

Henderson, Nevada, United States, 89052

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Recruiting

Henderson, Nevada, United States, 89074

Contacts

Principal Investigator:

John A. Ellerton

Oncology Las Vegas - Henderson

Recruiting

Henderson, Nevada, United States, 89074

Contacts

Principal Investigator:

John A. Ellerton

Urology Specialists of Nevada - Green Valley

Recruiting

Henderson, Nevada, United States, 89074

Contacts

Site Public Contact

research@sncrf.org

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at Charleston

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Principal Investigator:

John A. Ellerton

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Principal Investigator:

John A. Ellerton

Hope Cancer Care of Nevada

Recruiting

Las Vegas, Nevada, United States, 89103

Contacts

Principal Investigator:

John A. Ellerton

Radiation Oncology Centers of Nevada Central

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Principal Investigator:

John A. Ellerton

Urology Specialists of Nevada - Central

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Site Public Contact

research@sncrf.org

Principal Investigator:

John A. Ellerton

Sunrise Hospital and Medical Center

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Principal Investigator:

John A. Ellerton

Urology Specialists of Nevada - Southwest

Recruiting

Las Vegas, Nevada, United States, 89113

Contacts

Site Public Contact

research@sncrf.org

Principal Investigator:

John A. Ellerton

Radiation Oncology Centers of Nevada Southeast

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada - Northwest

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Principal Investigator:

John A. Ellerton

Oncology Las Vegas - Tenaya

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at MountainView

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Principal Investigator:

John A. Ellerton

Urology Specialists of Nevada - Northwest

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Site Public Contact

research@sncrf.org

Principal Investigator:

John A. Ellerton

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada - Town Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada-Summerlin

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

John A. Ellerton

Summerlin Hospital Medical Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89148

Contacts

Principal Investigator:

John A. Ellerton

Comprehensive Cancer Centers of Nevada - Central Valley

Recruiting

Las Vegas, Nevada, United States, 89169

Contacts

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at Fort Apache

Recruiting

Las Vegas, Nevada, United States, 89183

Contacts

Principal Investigator:

John A. Ellerton

Hope Cancer Care of Nevada-Pahrump

Recruiting

Pahrump, Nevada, United States, 89048

Contacts

Principal Investigator:

John A. Ellerton

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Principal Investigator:

John A. Ellerton

Saint Mary's Regional Medical Center

Recruiting

Reno, Nevada, United States, 89503

Contacts

Principal Investigator:

John A. Ellerton

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Jeffrey M. Clarke

Duke Cancer Center Southpoint

Recruiting

Durham, North Carolina, United States, 27713

Contacts

Site Public Contact

NCTNStudyTeam@dm.duke.edu

Principal Investigator:

Jeffrey M. Clarke

Duke Cancer Center Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Contacts

Site Public Contact

NCTNStudyTeam@dm.duke.edu

Principal Investigator:

Jeffrey M. Clarke

Saint Charles Health System

Recruiting

Bend, Oregon, United States, 97701

Contacts

Principal Investigator:

Alison K. Conlin

Clackamas Radiation Oncology Center

Recruiting

Clackamas, Oregon, United States, 97015

Contacts

Principal Investigator:

Alison K. Conlin

Bay Area Hospital

Recruiting

Coos Bay, Oregon, United States, 97420

Contacts

Principal Investigator:

Alison K. Conlin

Providence Hood River Memorial Hospital

Recruiting

Hood River, Oregon, United States, 97031

Contacts

Principal Investigator:

Alison K. Conlin

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Principal Investigator:

Alison K. Conlin

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Alison K. Conlin

Saint Charles Health System-Redmond

Recruiting

Redmond, Oregon, United States, 97756

Contacts

Site Public Contact

541-706-2909

Principal Investigator:

Alison K. Conlin

UT Southwestern Simmons Cancer Center - RedBird

Recruiting

Dallas, Texas, United States, 75237

Contacts

Principal Investigator:

David B. Nelson

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

David B. Nelson

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

David B. Nelson

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Principal Investigator:

David B. Nelson

Providence Regional Cancer System-Aberdeen

Recruiting

Aberdeen, Washington, United States, 98520

Contacts

Principal Investigator:

Alison K. Conlin

PeaceHealth Saint Joseph Medical Center

Recruiting

Bellingham, Washington, United States, 98225

Contacts

Principal Investigator:

Alison K. Conlin

Providence Regional Cancer System-Centralia

Recruiting

Centralia, Washington, United States, 98531

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Principal Investigator:

Alison K. Conlin

Providence Regional Cancer Partnership

Recruiting

Everett, Washington, United States, 98201

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Principal Investigator:

Alison K. Conlin

Kadlec Clinic Hematology and Oncology

Recruiting

Kennewick, Washington, United States, 99336

Contacts

Principal Investigator:

Alison K. Conlin

Providence Regional Cancer System-Lacey

Recruiting

Lacey, Washington, United States, 98503

Contacts

Principal Investigator:

Alison K. Conlin

PeaceHealth Saint John Medical Center

Recruiting

Longview, Washington, United States, 98632

Contacts

Principal Investigator:

Alison K. Conlin

Skagit Regional Health Cancer Care Center

Recruiting

Mount Vernon, Washington, United States, 98274

Contacts

Principal Investigator:

Alison K. Conlin

Valley Medical Center

Recruiting

Renton, Washington, United States, 98055

Contacts

Principal Investigator:

John A. Ellerton

Swedish Medical Center-Ballard Campus

Recruiting

Seattle, Washington, United States, 98107

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Medical Center-Cherry Hill

Recruiting

Seattle, Washington, United States, 98122-5711

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Alison K. Conlin

PeaceHealth United General Medical Center

Recruiting

Sedro-Woolley, Washington, United States, 98284

Contacts

Principal Investigator:

Alison K. Conlin

Cancer Care Northwest - Spokane South

Recruiting

Spokane, Washington, United States, 99202

Contacts

Principal Investigator:

Alison K. Conlin

Cancer Care Northwest-Valley

Recruiting

Spokane, Washington, United States, 99216

Contacts

Principal Investigator:

Alison K. Conlin

Cancer Care Northwest-North Spokane

Recruiting

Spokane, Washington, United States, 99218

Contacts

Principal Investigator:

Alison K. Conlin

PeaceHealth Southwest Medical Center

Recruiting

Vancouver, Washington, United States, 98664

Contacts

Principal Investigator:

Alison K. Conlin

Providence Saint Mary Regional Cancer Center

Recruiting

Walla Walla, Washington, United States, 99362

Contacts

Principal Investigator:

Alison K. Conlin

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Recruiting

Yakima, Washington, United States, 98902

Contacts

Principal Investigator:

John A. Ellerton

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-08-05.