Mesothelioma Clinical Trials

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Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

Status: Recruiting
Location: See all (132) locations...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
RECRUITING
Anchorage
Alaska Oncology and Hematology LLC
RECRUITING
Anchorage
Alaska Women's Cancer Care
RECRUITING
Anchorage
Anchorage Associates in Radiation Medicine
RECRUITING
Anchorage
Anchorage Radiation Therapy Center
SUSPENDED
Anchorage
Katmai Oncology Group
RECRUITING
Anchorage
Providence Alaska Medical Center
RECRUITING
Anchorage
Arizona
Kingman Regional Medical Center
RECRUITING
Kingman
Mayo Clinic Hospital in Arizona
RECRUITING
Phoenix
Mayo Clinic in Arizona
RECRUITING
Scottsdale
California
PCR Oncology
RECRUITING
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
RECRUITING
Burbank
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Providence Queen of The Valley
RECRUITING
Napa
Providence Medical Foundation - Santa Rosa
RECRUITING
Santa Rosa
Providence Santa Rosa Memorial Hospital
RECRUITING
Santa Rosa
Delaware
Beebe Medical Center
ACTIVE_NOT_RECRUITING
Lewes
Beebe South Coastal Health Campus
ACTIVE_NOT_RECRUITING
Millville
Christiana Care Health System-Christiana Hospital
ACTIVE_NOT_RECRUITING
Newark
Delaware Clinical and Laboratory Physicians PA
ACTIVE_NOT_RECRUITING
Newark
Helen F Graham Cancer Center
ACTIVE_NOT_RECRUITING
Newark
Medical Oncology Hematology Consultants PA
ACTIVE_NOT_RECRUITING
Newark
Beebe Health Campus
ACTIVE_NOT_RECRUITING
Rehoboth Beach
Christiana Care Health System-Wilmington Hospital
ACTIVE_NOT_RECRUITING
Wilmington
Florida
Mayo Clinic in Florida
SUSPENDED
Jacksonville
Idaho
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Saint Luke's Cancer Institute - Fruitland
RECRUITING
Fruitland
Saint Luke's Cancer Institute - Meridian
RECRUITING
Meridian
Saint Luke's Cancer Institute - Nampa
RECRUITING
Nampa
Saint Luke's Cancer Institute - Twin Falls
RECRUITING
Twin Falls
Illinois
Rush-Copley Medical Center
RECRUITING
Aurora
Northwestern University
RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Carle Physician Group-Effingham
RECRUITING
Effingham
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Northwestern Medicine Orland Park
RECRUITING
Orland Park
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Rush-Copley Healthcare Center
RECRUITING
Yorkville
Maryland
Christiana Care - Union Hospital
ACTIVE_NOT_RECRUITING
Elkton
Minnesota
University of Minnesota/Masonic Cancer Center
RECRUITING
Minneapolis
Mayo Clinic in Rochester
RECRUITING
Rochester
Montana
Saint Patrick Hospital - Community Hospital
RECRUITING
Missoula
North Carolina
Duke Cancer Center Southpoint
RECRUITING
Durham
Duke University Medical Center
RECRUITING
Durham
Duke Cancer Center Raleigh
RECRUITING
Raleigh
Nevada
Carson Tahoe Regional Medical Center
RECRUITING
Carson City
Cancer and Blood Specialists-Henderson
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
RECRUITING
Henderson
Las Vegas Cancer Center-Henderson
SUSPENDED
Henderson
Las Vegas Urology - Green Valley
RECRUITING
Henderson
Las Vegas Urology - Pebble
RECRUITING
Henderson
Oncology Las Vegas - Henderson
RECRUITING
Henderson
Urology Specialists of Nevada - Green Valley
RECRUITING
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Ann M Wierman MD LTD
SUSPENDED
Las Vegas
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
RECRUITING
Las Vegas
Hope Cancer Care of Nevada
RECRUITING
Las Vegas
Las Vegas Cancer Center-Medical Center
SUSPENDED
Las Vegas
Las Vegas Prostate Cancer Center
RECRUITING
Las Vegas
Las Vegas Urology - Cathedral Rock
RECRUITING
Las Vegas
Las Vegas Urology - Pecos
RECRUITING
Las Vegas
Las Vegas Urology - Smoke Ranch
RECRUITING
Las Vegas
Las Vegas Urology - Sunset
RECRUITING
Las Vegas
Oncology Las Vegas - Tenaya
RECRUITING
Las Vegas
OptumCare Cancer Care at Charleston
RECRUITING
Las Vegas
OptumCare Cancer Care at Fort Apache
RECRUITING
Las Vegas
OptumCare Cancer Care at MountainView
RECRUITING
Las Vegas
Radiation Oncology Centers of Nevada Central
RECRUITING
Las Vegas
Radiation Oncology Centers of Nevada Southeast
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Sunrise Hospital and Medical Center
RECRUITING
Las Vegas
University Cancer Center
RECRUITING
Las Vegas
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
Urology Specialists of Nevada - Central
RECRUITING
Las Vegas
Urology Specialists of Nevada - Northwest
RECRUITING
Las Vegas
Urology Specialists of Nevada - Southwest
RECRUITING
Las Vegas
Hope Cancer Care of Nevada-Pahrump
RECRUITING
Pahrump
Radiation Oncology Associates
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
Saint Mary's Regional Medical Center
RECRUITING
Reno
Oregon
Saint Charles Health System
RECRUITING
Bend
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Providence Cancer Institute Clackamas Clinic
SUSPENDED
Clackamas
Bay Area Hospital
RECRUITING
Coos Bay
Providence Hood River Memorial Hospital
RECRUITING
Hood River
Providence Newberg Medical Center
RECRUITING
Newberg
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Saint Charles Health System-Redmond
RECRUITING
Redmond
Pennsylvania
Christiana Care Health System-Concord Health Center
ACTIVE_NOT_RECRUITING
Chadds Ford
Texas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Washington
Providence Regional Cancer System-Aberdeen
RECRUITING
Aberdeen
Overlake Medical Center
SUSPENDED
Bellevue
PeaceHealth Saint Joseph Medical Center
RECRUITING
Bellingham
Providence Regional Cancer System-Centralia
RECRUITING
Centralia
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Providence Regional Cancer Partnership
RECRUITING
Everett
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Kadlec Clinic Hematology and Oncology
RECRUITING
Kennewick
Providence Regional Cancer System-Lacey
RECRUITING
Lacey
PeaceHealth Saint John Medical Center
RECRUITING
Longview
Skagit Regional Health Cancer Care Center
RECRUITING
Mount Vernon
Valley Medical Center
RECRUITING
Renton
Swedish Medical Center-Ballard Campus
RECRUITING
Seattle
Swedish Medical Center-Cherry Hill
RECRUITING
Seattle
Swedish Medical Center-First Hill
RECRUITING
Seattle
PeaceHealth United General Medical Center
RECRUITING
Sedro-woolley
Providence Regional Cancer System-Shelton
SUSPENDED
Shelton
Cancer Care Northwest - Spokane South
RECRUITING
Spokane
Cancer Care Northwest-North Spokane
RECRUITING
Spokane
Cancer Care Northwest-Valley
RECRUITING
Spokane
PeaceHealth Southwest Medical Center
RECRUITING
Vancouver
Providence Saint Mary Regional Cancer Center
RECRUITING
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
RECRUITING
Yakima
Providence Regional Cancer System-Yelm
SUSPENDED
Yelm
Contact Information
Primary
Aaron Mansfield, MD
mansfield.aaron@mayo.edu
507-293-0569
Backup
Colleen Watt
cwatt@bsd.uchicago.edu
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 26
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov