Back to Trials
NCT05647265PHASE2Recruiting

Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

Alliance for Clinical Trials in Oncology

Start Date

11/27/2024

Completion Date

12/15/2026

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.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the percentage of patients with potentially resectable non-epithelioid mesothelioma who are able to proceed with surgery after neoadjuvant ipilimumab and nivolumab. II. To determine the progression-free survival rate at 12 months after the initiation of neoadjuvant ipilimumab and nivolumab. SECONDARY OBJECTIVES: I. To determine the rate of intra-operative or post-operative complications following neoadjuvant immunotherapy. II. Best response per modified pleural Response Evaluation Criteria in Solid Tumors (RECIST). III. Major pathologic response rate. IV. Time to recurrence after surgery. EXPLORATORY OBJECTIVES: I. To evaluate the association between the change in peripheral T cell clonality relative to baseline and treatment response. II. To evaluate the association between PD-L1 expression at baseline and treatment response. III. To evaluate whether a novel mesothelioma immune signature identified by Dr. Mansfield's laboratory is predictive of response. OUTLINE: Patients receive nivolumab intravenously (IV), ipilimumab IV, and may undergo surgery on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and positron emission tomography (PET) throughout the trial.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Nivolumab

BIOLOGICAL

Ipilimumab

PROCEDURE

Surgical Procedure

PROCEDURE

Computed Tomography

PROCEDURE

Magnetic Resonance Imaging

PROCEDURE

Positron Emission Tomography

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pleural Biphasic MesotheliomaPleural Sarcomatoid Mesothelioma

Locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska 98508

United States

Anchorage Radiation Therapy Center

Anchorage, Alaska 99504

United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska 99508

United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska 99508

United States

Alaska Women's Cancer Care

Anchorage, Alaska 99508

United States

Katmai Oncology Group

Anchorage, Alaska 99508

United States

Providence Alaska Medical Center

Anchorage, Alaska 99508

United States

Kingman Regional Medical Center

Kingman, Arizona 86401

United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona 85054

United States

Mayo Clinic in Arizona

Scottsdale, Arizona 85259

United States

PCR Oncology

Arroyo Grande, California 93420

United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California 91505

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Providence Queen of The Valley

Napa, California 94558

United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California 95403

United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California 95405

United States

Beebe Medical Center

Lewes, Delaware 19958

United States

Beebe South Coastal Health Campus

Millville, Delaware 19967

United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware 19713

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware 19971

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware 19801

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224-9980

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho 83712

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho 83687

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho 83301

United States

Rush-Copley Medical Center

Aurora, Illinois 60504

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois 60637

United States

Carle at The Riverfront

Danville, Illinois 61832

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois 60115

United States

Carle Physician Group-Effingham

Effingham, Illinois 62401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois 60030

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois 60045

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois 61938

United States

Northwestern Medicine Orland Park

Orland Park, Illinois 60462

United States

Carle Cancer Center

Urbana, Illinois 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois 60555

United States

Rush-Copley Healthcare Center

Yorkville, Illinois 60560

United States

Christiana Care - Union Hospital

Elkton, Maryland 21921

United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota 55455

United States

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana 59802

United States

Carson Tahoe Regional Medical Center

Carson City, Nevada 89703

United States

Cancer and Blood Specialists-Henderson

Henderson, Nevada 89052

United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada 89052

United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada 89052

United States

Las Vegas Cancer Center-Henderson

Henderson, Nevada 89052

United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada 89074

United States

Las Vegas Urology - Green Valley

Henderson, Nevada 89074

United States

Las Vegas Urology - Pebble

Henderson, Nevada 89074

United States

Oncology Las Vegas - Henderson

Henderson, Nevada 89074

United States

Urology Specialists of Nevada - Green Valley

Henderson, Nevada 89074

United States

Las Vegas Urology - Pecos

Las Vegas, Nevada 89074

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada 89102

United States

University Medical Center of Southern Nevada

Las Vegas, Nevada 89102

United States

Hope Cancer Care of Nevada

Las Vegas, Nevada 89103

United States

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada 89106

United States

Urology Specialists of Nevada - Central

Las Vegas, Nevada 89106

United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada 89109

United States

Las Vegas Prostate Cancer Center

Las Vegas, Nevada 89113

United States

Las Vegas Urology - Sunset

Las Vegas, Nevada 89113

United States

Urology Specialists of Nevada - Southwest

Las Vegas, Nevada 89113

United States

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada 89119

United States

Ann M Wierman MD LTD

Las Vegas, Nevada 89128

United States

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada 89128

United States

Las Vegas Urology - Cathedral Rock

Las Vegas, Nevada 89128

United States

Las Vegas Urology - Smoke Ranch

Las Vegas, Nevada 89128

United States

Oncology Las Vegas - Tenaya

Las Vegas, Nevada 89128

United States

OptumCare Cancer Care at MountainView

Las Vegas, Nevada 89128

United States

Urology Specialists of Nevada - Northwest

Las Vegas, Nevada 89128

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada 89135

United States

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada 89144

United States

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada 89144

United States

Summerlin Hospital Medical Center

Las Vegas, Nevada 89144

United States

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada 89148-2405

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89148

United States

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada 89169

United States

University Cancer Center

Las Vegas, Nevada 89169

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada 89183

United States

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada 89048

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Saint Mary's Regional Medical Center

Reno, Nevada 89503

United States

Radiation Oncology Associates

Reno, Nevada 89509

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Duke Cancer Center Southpoint

Durham, North Carolina 27713

United States

Duke Cancer Center Raleigh

Raleigh, North Carolina 27609

United States

Saint Charles Health System

Bend, Oregon 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon 97015

United States

Bay Area Hospital

Coos Bay, Oregon 97420

United States

Providence Hood River Memorial Hospital

Hood River, Oregon 97031

United States

Providence Newberg Medical Center

Newberg, Oregon 97132

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon 97045

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon 97225

United States

Saint Charles Health System-Redmond

Redmond, Oregon 97756

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania 19317

United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas 75237

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas 75390

United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas 76104

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas 75080

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington 98520

United States

Overlake Medical Center

Bellevue, Washington 98004

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington 98225

United States

Providence Regional Cancer System-Centralia

Centralia, Washington 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington 98026

United States

Providence Regional Cancer Partnership

Everett, Washington 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington 98632

United States

Skagit Regional Health Cancer Care Center

Mount Vernon, Washington 98274

United States

Valley Medical Center

Renton, Washington 98055

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington 98107

United States

Swedish Medical Center-Cherry Hill

Seattle, Washington 98122-5711

United States

Swedish Medical Center-First Hill

Seattle, Washington 98122

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington 98284

United States

Providence Regional Cancer System-Shelton

Shelton, Washington 98584

United States

Cancer Care Northwest - Spokane South

Spokane, Washington 99202

United States

Cancer Care Northwest-Valley

Spokane, Washington 99216

United States

Cancer Care Northwest-North Spokane

Spokane, Washington 99218

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington 98664

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington 99362

United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington 98902

United States

Providence Regional Cancer System-Yelm

Yelm, Washington 98597

United States