Pleural Biphasic MesotheliomaPhase 2NCT05647265
Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
A Phase 2 study testing Nivolumab, Ipilimumab and Surgical Procedure in people with Pleural Biphasic Mesothelioma and Pleural Sarcomatoid Mesothelioma, run by Alliance for Clinical Trials in Oncology at 132 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Biphasic Mesothelioma, Pleural Sarcomatoid Mesothelioma
- What is being tested?
- Nivolumab, Ipilimumab and Surgical Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 132 sitesUnited States
- Study dates
- 27 Nov 2024to 15 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
132 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colleen Watt contact
132 sites in 1 country
United States132 sites, 104 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Tanmay Sahai
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223, achapman1@peacehealth.org
Alison K. Conlin
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Alison K. Conlin
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Alison K. Conlin
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Active, not recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Young Kwang Chae
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Hedy L. Kindler
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Alison K. Conlin
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
David B. Nelson
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
David B. Nelson
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Tanmay Sahai
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Young Kwang Chae
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Jeffrey M. Clarke
- Recruiting
Duke Cancer Center Southpoint
Durham, North Carolina, 27713
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Jeffrey M. Clarke
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Active, not recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Alison K. Conlin
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
David B. Nelson
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Young Kwang Chae
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Young Kwang Chae
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Young Kwang Chae
- Suspended
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
- Suspended
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
- Recruiting
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Site Public Contact, 503-215-1979, canrsrchstudies@provdience.org
Alison K. Conlin
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Aaron S. Mansfield
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Alison K. Conlin
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Lyudmila A. Bazhenova
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Young Kwang Chae
- Suspended
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113
- Suspended
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113
- Recruiting
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128
- Recruiting
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128
- Suspended
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128
- Recruiting
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
University Cancer Center
Las Vegas, Nevada, 89169
- Recruiting
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Active, not recruiting
Beebe Medical Center
Lewes, Delaware, 19958
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Alison K. Conlin
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Active, not recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Site Public Contact, 612-624-2620
Robert A. Kratzke
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Alison K. Conlin
- Recruiting
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274
Site Public Contact, 360-814-2182, rcccclinicalresearch@skagitvalleyhospital.org
Alison K. Conlin
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Providence Queen of The Valley
Napa, California, 94558
Site Public Contact, 707-521-3830
Alison K. Conlin
- Active, not recruiting
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
- Active, not recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
- Active, not recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
- Active, not recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Young Kwang Chae
- Recruiting
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Site Public Contact, 855-776-0015
Aaron S. Mansfield
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Jeffrey M. Clarke
- Recruiting
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Site Public Contact, 541-706-2909
Alison K. Conlin
- Active, not recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 775-982-5050, Renown-CRD@renown.org
John A. Ellerton
- Recruiting
Saint Mary's Regional Medical Center
Reno, Nevada, 89503
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Radiation Oncology Associates
Reno, Nevada, 89509
- Recruiting
Valley Medical Center
Renton, Washington, 98055
Site Public Contact, 425-228-3440, research@valleymed.org
John A. Ellerton
- Recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu
David B. Nelson
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Aaron S. Mansfield
- Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 707-521-3830
Alison K. Conlin
- Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405
Site Public Contact, 707-521-3830
Alison K. Conlin
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Site Public Contact, 855-776-0015
Aaron S. Mansfield
- Recruiting
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Site Public Contact, 360-788-8239, achapman1@peacehealth.org
Alison K. Conlin
- Suspended
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
- Recruiting
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Site Public Contact, 509-228-1680, research@ccnw.net
Alison K. Conlin
- Recruiting
Cancer Care Northwest-Valley
Spokane, Washington, 99216
Site Public Contact, 509-228-1680, research@ccnw.net
Alison K. Conlin
- Recruiting
Cancer Care Northwest-North Spokane
Spokane, Washington, 99218
Site Public Contact, 509-228-1680, research@ccnw.net
Alison K. Conlin
- Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Site Public Contact, 360-514-3940, kmakin-bond@peacehealth.org
Alison K. Conlin
- Recruiting
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Site Public Contact, 509-897-5993, Cheryl.Dodd@providence.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Young Kwang Chae
- Active, not recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
- Recruiting
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Site Public Contact, 509-574-3535, Memorial-ClinicalTrials@yvmh.org
John A. Ellerton
- Suspended
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
- Recruiting
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Tanmay Sahai
About this study
Official title: Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Being tested
- Nivolumab, Ipilimumab, Surgical Procedure, Computed Tomography, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called 946414-94-4, BMS-936558, CMAB819, MDX-1106, NIVO, NIVOLUMAB, Nivolumab, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
Given IV
IpilimumabBiological
Also called 477202-00-9, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, IPILIMUMAB, ipilimumab, Ipilimumab Biosimilar CS1002, MDX-010, MDX-010, MDX-CTLA4, Yervoy
Given IV
Surgical ProcedureProcedure or surgery
Undergo surgery
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan,
undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called MRI
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, Pet Scan
Undergo PET
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nivolumab, ipilimumab, surgery) | Experimental | Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial. Receives: Biological: Nivolumab; Biological: Ipilimumab; Procedure: Surgical Procedure; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery Rate
The rate of surgery after neoadjuvant immunotherapy among the feasibility analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.
Measured: immediately after the completion of neoadjuvant immunotherapy and surgery
Progression free survival (PFS)
PFS will be determined per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The rate of PFS at 12 months after the initiation of neoadjuvant immunotherapy among the feasibility and efficacy analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.
Measured: At 12 months after initiation of neoadjuvant immunotherapy
Secondary outcomes (4)
Incidence of adverse events
The type of adverse events, the frequency of each type and its grade will be summarized. The frequency and the percentage of severe adverse events will be presented in bar charts over treatment phase (neoadjuvant immunotherapy, surgery) to describe the change of adverse event or complication severity over time. The rates of the pre-operative or post-operative complications (within 30 days of surgery) will be estimated with its exact 95% confidence interval.
Measured: Up to 5 years
Objective response rate
Will be determined per modified RECIST. Response rate will be reported with 95% exact confidence interval.
Measured: Up to 5 years
Major pathologic response
Defined as =< 10% residual viable tumor in the resected lung and lymph node tissue. Response rates will be reported with 95% exact confidence interval.
Measured: Up to 5 years
Time to recurrence
Time to recurrence will be estimated among those patients who receive surgery and will be characterized by estimating cumulative incidence function and conducting cause-specific and subdistribution hazard regression.
Measured: Time from surgery to disease relapse, progression, or second tumor, whichever occurs first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start27 Nov 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Biphasic MesotheliomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647265
- Sponsor's protocol ID
- A082101
- Other IDs
- NCI-2022-09320, U10CA180821
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided