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

RecruitingPhase 2

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Alliance for Clinical Trials in Oncology · Participants: 26 · Started: Nov 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05647265

Locations in the U.S.

AlaskaAlaska Breast Care and Surgery LLC, Anchorage
Alaska Oncology and Hematology LLC, Anchorage
Alaska Women's Cancer Care, Anchorage
Anchorage Associates in Radiation Medicine, Anchorage
Katmai Oncology Group, Anchorage
Providence Alaska Medical Center, Anchorage
ArizonaKingman Regional Medical Center, Kingman
Mayo Clinic Hospital in Arizona, Phoenix
Mayo Clinic in Arizona, Scottsdale
CaliforniaPCR Oncology, Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank
UC San Diego Moores Cancer Center, La Jolla
Providence Queen of The Valley, Napa
Providence Medical Foundation - Santa Rosa, Santa Rosa
Providence Santa Rosa Memorial Hospital, Santa Rosa
FloridaMayo Clinic in Florida, Jacksonville
IdahoSaint Luke's Cancer Institute - Boise, Boise
Saint Luke's Cancer Institute - Fruitland, Fruitland
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Luke's Cancer Institute - Nampa, Nampa
Saint Luke's Cancer Institute - Twin Falls, Twin Falls
IllinoisRush-Copley Medical Center, Aurora
Northwestern University, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
Carle at The Riverfront, Danville
Northwestern Medicine Cancer Center Kishwaukee, DeKalb
Carle Physician Group-Effingham, Effingham
Northwestern Medicine Cancer Center Delnor, Geneva
Northwestern Medicine Glenview Outpatient Center, Glenview
Northwestern Medicine Grayslake Outpatient Center, Grayslake
Northwestern Medicine Lake Forest Hospital, Lake Forest
Carle Physician Group-Mattoon/Charleston, Mattoon
Northwestern Medicine Orland Park, Orland Park
Carle Cancer Center, Urbana
Northwestern Medicine Cancer Center Warrenville, Warrenville
Rush-Copley Healthcare Center, Yorkville
MinnesotaUniversity of Minnesota/Masonic Cancer Center, Minneapolis
Mayo Clinic in Rochester, Rochester
MontanaSaint Patrick Hospital - Community Hospital, Missoula
NevadaCarson Tahoe Regional Medical Center, Carson City
Comprehensive Cancer Centers of Nevada - Henderson, Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson
Oncology Las Vegas - Henderson, Henderson
Urology Specialists of Nevada - Green Valley, Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas
Comprehensive Cancer Centers of Nevada, Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas
Hope Cancer Care of Nevada, Las Vegas
Oncology Las Vegas - Tenaya, Las Vegas
OptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
OptumCare Cancer Care at MountainView, Las Vegas
Radiation Oncology Centers of Nevada Central, Las Vegas
Radiation Oncology Centers of Nevada Southeast, Las Vegas
Summerlin Hospital Medical Center, Las Vegas
Sunrise Hospital and Medical Center, Las Vegas
University Medical Center of Southern Nevada, Las Vegas
Urology Specialists of Nevada - Central, Las Vegas
Urology Specialists of Nevada - Northwest, Las Vegas
Urology Specialists of Nevada - Southwest, Las Vegas
Hope Cancer Care of Nevada-Pahrump, Pahrump
Renown Regional Medical Center, Reno
Saint Mary's Regional Medical Center, Reno
North CarolinaDuke Cancer Center Southpoint, Durham
Duke University Medical Center, Durham
Duke Cancer Center Raleigh, Raleigh
OregonSaint Charles Health System, Bend
Clackamas Radiation Oncology Center, Clackamas
Bay Area Hospital, Coos Bay
Providence Hood River Memorial Hospital, Hood River
Providence Newberg Medical Center, Newberg
Providence Willamette Falls Medical Center, Oregon City
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
Saint Charles Health System-Redmond, Redmond
TexasUT Southwestern Simmons Cancer Center - RedBird, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth
UT Southwestern Clinical Center at Richardson/Plano, Richardson
WashingtonProvidence Regional Cancer System-Aberdeen, Aberdeen
PeaceHealth Saint Joseph Medical Center, Bellingham
Providence Regional Cancer System-Centralia, Centralia
Swedish Cancer Institute-Edmonds, Edmonds
Providence Regional Cancer Partnership, Everett
Swedish Cancer Institute-Issaquah, Issaquah
Kadlec Clinic Hematology and Oncology, Kennewick
Providence Regional Cancer System-Lacey, Lacey
PeaceHealth Saint John Medical Center, Longview
Skagit Regional Health Cancer Care Center, Mount Vernon
Valley Medical Center, Renton
Swedish Medical Center-Ballard Campus, Seattle
Swedish Medical Center-Cherry Hill, Seattle
Swedish Medical Center-First Hill, Seattle
PeaceHealth United General Medical Center, Sedro-Woolley
Cancer Care Northwest - Spokane South, Spokane
Cancer Care Northwest-North Spokane, Spokane
Cancer Care Northwest-Valley, Spokane
PeaceHealth Southwest Medical Center, Vancouver
Providence Saint Mary Regional Cancer Center, Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.