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

Primary Purpose

Pleural Biphasic Mesothelioma, Pleural Sarcomatoid Mesothelioma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Surgical Procedure
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Biphasic Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingman Regional Medical CenterRecruiting
  • PCR OncologyRecruiting
  • Beebe South Coastal Health CampusRecruiting
  • Beebe Medical CenterRecruiting
  • Delaware Clinical and Laboratory Physicians PARecruiting
  • Helen F Graham Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants PARecruiting
  • Christiana Care Health System-Christiana HospitalRecruiting
  • Beebe Health CampusRecruiting
  • Christiana Care Health System-Wilmington HospitalRecruiting
  • Northwestern UniversityRecruiting
  • University of Chicago Comprehensive Cancer CenterRecruiting
  • Northwestern Medicine Cancer Center KishwaukeeRecruiting
  • Northwestern Medicine Cancer Center DelnorRecruiting
  • Northwestern Medicine Lake Forest HospitalRecruiting
  • Northwestern Medicine Cancer Center WarrenvilleRecruiting
  • Christiana Care - Union HospitalRecruiting
  • Carson Tahoe Regional Medical CenterRecruiting
  • Cancer and Blood Specialists-HendersonRecruiting
  • Comprehensive Cancer Centers of Nevada - HendersonRecruiting
  • Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
  • Las Vegas Cancer Center-Henderson
  • OptumCare Cancer Care at Seven HillsRecruiting
  • Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
  • GenesisCare USA - HendersonRecruiting
  • Las Vegas Urology - Green ValleyRecruiting
  • Las Vegas Urology - PebbleRecruiting
  • Urology Specialists of Nevada - Green ValleyRecruiting
  • Las Vegas Urology - PecosRecruiting
  • OptumCare Cancer Care at CharlestonRecruiting
  • University Medical Center of Southern NevadaRecruiting
  • Hope Cancer Care of NevadaRecruiting
  • Radiation Oncology Centers of Nevada CentralRecruiting
  • Urology Specialists of Nevada - CentralRecruiting
  • GenesisCare USA - Las VegasRecruiting
  • Sunrise Hospital and Medical CenterRecruiting
  • Las Vegas Prostate Cancer CenterRecruiting
  • Las Vegas Urology - SunsetRecruiting
  • Urology Specialists of Nevada - SouthwestRecruiting
  • Radiation Oncology Centers of Nevada SoutheastRecruiting
  • Ann M Wierman MD LTDRecruiting
  • Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
  • GenesisCare USA - Vegas TenayaRecruiting
  • Las Vegas Urology - Cathedral RockRecruiting
  • Las Vegas Urology - Smoke RanchRecruiting
  • OptumCare Cancer Care at MountainViewRecruiting
  • Urology Specialists of Nevada - NorthwestRecruiting
  • Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
  • Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
  • Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
  • Summerlin Hospital Medical CenterRecruiting
  • Las Vegas Cancer Center-Medical Center
  • Comprehensive Cancer Centers of NevadaRecruiting
  • GenesisCare USA - Fort ApacheRecruiting
  • OptumCare Cancer Care at Fort ApacheRecruiting
  • Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
  • University Cancer CenterRecruiting
  • Hope Cancer Care of Nevada-PahrumpRecruiting
  • Renown Regional Medical CenterRecruiting
  • Saint Mary's Regional Medical CenterRecruiting
  • Radiation Oncology AssociatesRecruiting
  • Christiana Care Health System-Concord Health CenterRecruiting
  • Overlake Medical Center
  • Valley Medical CenterRecruiting
  • North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (nivolumab, ipilimumab, surgery)

Arm Description

Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Objective response rate
Will be determined per modified RECIST. Response rate will be reported with 95% exact confidence interval.
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.
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.

Full Information

First Posted
November 29, 2022
Last Updated
July 26, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05647265
Brief Title
Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
Official Title
Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Biphasic Mesothelioma, Pleural Sarcomatoid Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (nivolumab, ipilimumab, surgery)
Arm Type
Experimental
Arm Description
Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
946414-94-4, BMS-936558, CMAB819, MDX-1106, NIVO, NIVOLUMAB, Nivolumab, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Surgical Procedure
Intervention Description
Undergo surgery
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan,
Intervention Description
undergo CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, PET, Pet Scan
Intervention Description
Undergo PET
Primary Outcome Measure Information:
Title
Surgery Rate
Description
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.
Time Frame
immediately after the completion of neoadjuvant immunotherapy and surgery
Title
Progression free survival (PFS)
Description
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.
Time Frame
At 12 months after initiation of neoadjuvant immunotherapy
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
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.
Time Frame
Up to 5 years
Title
Objective response rate
Description
Will be determined per modified RECIST. Response rate will be reported with 95% exact confidence interval.
Time Frame
Up to 5 years
Title
Major pathologic response
Description
Defined as =< 10% residual viable tumor in the resected lung and lymph node tissue. Response rates will be reported with 95% exact confidence interval.
Time Frame
Up to 5 years
Title
Time to recurrence
Description
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.
Time Frame
Time from surgery to disease relapse, progression, or second tumor, whichever occurs first, assessed up to 5 years
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
The association of pre-treatment and on-treatment biomarkers in peripheral blood and in tumor tissues with response and time to recurrence, will be evaluated univariately through Chi-square test or log-rank test and through logistic regression model or Cox regression model with other prognostic factors adjusted.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Mansfield, MD
Phone
507-293-0569
Email
mansfield.aaron@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Watt
Email
cwatt@bsd.uchicago.edu
Facility Information:
Facility Name
Kingman Regional Medical Center
City
Kingman
State/Province
Arizona
ZIP/Postal Code
86401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
PCR Oncology
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Delaware Clinical and Laboratory Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
mhayden@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Christiana Care Health System-Wilmington Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-695-1301
Email
cancer@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Hedy L. Kindler
Facility Name
Northwestern Medicine Cancer Center Kishwaukee
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Northwestern Medicine Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
cancertrials@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Christiana Care - Union Hospital
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-620-3710
Email
sstewart@uhcc.com
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Carson Tahoe Regional Medical Center
City
Carson City
State/Province
Nevada
ZIP/Postal Code
89703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Cancer and Blood Specialists-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada-Horizon Ridge
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Cancer Center-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Suspended
Facility Name
OptumCare Cancer Care at Seven Hills
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada-Southeast Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
GenesisCare USA - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Urology - Green Valley
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Urology - Pebble
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Urology Specialists of Nevada - Green Valley
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Urology - Pecos
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
OptumCare Cancer Care at Charleston
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Hope Cancer Care of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Radiation Oncology Centers of Nevada Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Urology Specialists of Nevada - Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
GenesisCare USA - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Prostate Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Urology - Sunset
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Urology Specialists of Nevada - Southwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Radiation Oncology Centers of Nevada Southeast
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Ann M Wierman MD LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada - Northwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
GenesisCare USA - Vegas Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Urology - Cathedral Rock
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Urology - Smoke Ranch
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@smcrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
OptumCare Cancer Care at MountainView
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Urology Specialists of Nevada - Northwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada - Town Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada-Summerlin
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Summerlin Hospital Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Las Vegas Cancer Center-Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148-2405
Country
United States
Individual Site Status
Suspended
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
GenesisCare USA - Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Comprehensive Cancer Centers of Nevada - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
University Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Hope Cancer Care of Nevada-Pahrump
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Saint Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Radiation Oncology Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
702-384-0013
Email
research@sncrf.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
Christiana Care Health System-Concord Health Center
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Overlake Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Suspended
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
425-228-3440
Email
research@valleymed.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
509-574-3535
Email
Memorial-ClinicalTrials@yvmh.org
First Name & Middle Initial & Last Name & Degree
John A. Ellerton

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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