RECRUITING

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

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Conditions

Pleural Biphasic MesotheliomaPleural Sarcomatoid Mesothelioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

Quick Facts

Study Start:2023-03-14
Study Completion:2024-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05647265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sarcomatoid or sarcomatoid-dominant (\> 50%) biphasic, pleural mesothelioma
  2. * Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition
  3. * Measurable disease or non-measurable disease as defined
  4. * No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint
  5. * 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.)
  6. * 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
  7. * Age \>= 18 years
  8. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 or Karnofsky \>= 60%
  9. * Absolute neutrophil count (ANC) \>= 1,000/mm\^3
  10. * Leukocytes \>= 2,000/mm\^3
  11. * Platelet count \>= 100,000/mm\^3
  12. * Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \>= 40 mL/min
  13. * Total bilirubin =\<1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dl
  14. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN
  15. * Alkaline (alk) phosphatase (phos) =\< 3.0 x ULN
  16. * 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
  17. * No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody
  18. * 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
  19. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  20. * 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
  21. * 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
  22. * STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery
  23. * STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection
  24. * STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =\< 2 or Karnofsky \>= 60%
  25. * 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%
  26. * 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
  1. * No patients deemed to be unresectable or poor surgical candidates
  2. * 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
  3. * No patients with a history of symptomatic interstitial lung disease

Contacts and Locations

Study Contact

Aaron Mansfield, MD
CONTACT
507-293-0569
mansfield.aaron@mayo.edu
Colleen Watt
CONTACT
cwatt@bsd.uchicago.edu

Study Locations (Sites)

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
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, 83686
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
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
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
United States
GenesisCare USA - 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
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
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
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
GenesisCare USA - Vegas Tenaya
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
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
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148
United States
OptumCare Cancer Care at Fort Apache
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
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
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 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
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
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

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14
Study Completion Date2024-12-15

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2024-12-15

Terms related to this study

Additional Relevant MeSH Terms

  • Pleural Biphasic Mesothelioma
  • Pleural Sarcomatoid Mesothelioma