Trial Title:
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
NCT ID:
NCT06422806
Condition:
Metastatic Undifferentiated Pleomorphic Sarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Unresectable Undifferentiated Pleomorphic Sarcoma
Conditions: Official terms:
Sarcoma
Histiocytoma, Malignant Fibrous
Pembrolizumab
Doxorubicin
Liposomal doxorubicin
Daunorubicin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm A (doxorubicin and pembrolizumab
Arm group label:
Arm B (doxorubicin)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Diagnostic Imaging
Description:
Undergo standard imaging scans
Arm group label:
Arm A (doxorubicin and pembrolizumab
Arm group label:
Arm B (doxorubicin)
Other name:
Medical Imaging
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Given IV
Arm group label:
Arm A (doxorubicin and pembrolizumab
Arm group label:
Arm B (doxorubicin)
Other name:
Adriablastin
Other name:
Hydroxydaunomycin
Other name:
Hydroxyl Daunorubicin
Other name:
Hydroxyldaunorubicin
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Arm A (doxorubicin and pembrolizumab
Arm group label:
Arm B (doxorubicin)
Other name:
EC
Intervention type:
Procedure
Intervention name:
Multigated Acquisition Scan
Description:
Undergo MUGA scan
Arm group label:
Arm A (doxorubicin and pembrolizumab
Arm group label:
Arm B (doxorubicin)
Other name:
Blood Pool Scan
Other name:
Equilibrium Radionuclide Angiography
Other name:
Gated Blood Pool Imaging
Other name:
Gated Heart Pool Scan
Other name:
MUGA
Other name:
MUGA Scan
Other name:
Multi-Gated Acquisition Scan
Other name:
Radionuclide Ventriculogram Scan
Other name:
Radionuclide Ventriculography
Other name:
RNV Scan
Other name:
RNVG
Other name:
SYMA Scanning
Other name:
Synchronized Multigated Acquisition Scanning
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Given IV
Arm group label:
Arm A (doxorubicin and pembrolizumab
Other name:
BCD-201
Other name:
GME 751
Other name:
GME751
Other name:
Keytruda
Other name:
Lambrolizumab
Other name:
MK 3475
Other name:
MK-3475
Other name:
MK3475
Other name:
Pembrolizumab Biosimilar BCD-201
Other name:
Pembrolizumab Biosimilar GME751
Other name:
Pembrolizumab Biosimilar QL2107
Other name:
QL2107
Other name:
SCH 900475
Other name:
SCH-900475
Other name:
SCH900475
Summary:
This phase II trial compares the effect of immunotherapy (pembrolizumab) plus
chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with
undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma
that has spread from where it first started to other places in the body (metastatic) or
that cannot be removed by surgery (unresectable). Doxorubicin is in a class of
medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor
cells. It also blocks a certain enzyme needed for cell division and DNA repair. A
monoclonal antibody is a type of protein that can bind to certain targets in the body,
such as molecules that cause the body to make an immune response (antigens).
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells to
grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy
(doxorubicin) may help patients with metastatic or unresectable UPS or a related poorly
differentiated sarcoma live longer without having disease progression.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess whether the combination of doxorubicin and pembrolizumab will improve
progression free survival (PFS) in UPS and related poorly differentiated sarcomas
relative to doxorubicin alone.
KEY SECONDARY OBJECTIVE:
I. To assess whether the combination of doxorubicin and pembrolizumab versus (vs) the
re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression
(i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival
(OS).
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability in each treatment arm. II. To quantify overall
response rate (ORR) and durability of response (DOR) in each treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive doxorubicin intravenously (IV) over 3-10 minutes or up to 3 hours
on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of
disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over
30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence
of disease progression or unacceptable toxicity.
ARM B: Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of
each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease
progression or unacceptable toxicity. At time of disease progression, patients may begin
receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat
every 21 days for 2 years in the absence of additional progression or unacceptable
toxicity.
Patients in both arms also undergo echocardiogram (ECHO) or multigated acquisition (MUGA)
scan during screening, as well as standard imaging scans and blood sample collection
throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years
and then every 6 months in years 2-10.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patient must have a confirmed histopathologic diagnosis of undifferentiated
pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS
can sometimes exist in a spectrum among related diagnoses, the following additional
diagnostic will be allowed, but not limited to:
- Pleomorphic sarcoma with inflammation or with limited areas of differentiation
- Pleomorphic sarcoma with giant cells
- Malignant fibrous histiocytoma (including storiform-pleomorphic and
inflammatory subtypes)
- Myxofibrosarcoma, poorly differentiated sarcoma not otherwise specified (NOS)
- Undifferentiated spindle cell sarcoma
- Pleomorphic dermal sarcoma
- Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have
areas of focal myogenic differentiation
- Patient must have metastatic or unresectable sarcoma
- Patient must not be pregnant or breast-feeding due to the potential harm to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used. All patients of childbearing potential must have a
blood test or urine study within 14 days prior to randomization to rule out
pregnancy. A patient of childbearing potential is defined as anyone, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria:
- Has achieved menarche at some point
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does
not rule out childbearing potential) for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months)
- Patient must not expect to conceive or father children by using an accepted and
effective method(s) of contraception or by abstaining from sexual intercourse for
the duration of their participation in the study. Contraception measures must
continue for 6 months after the last dose of doxorubicin for patients of child
bearing potential and for 3 months after the last dose of doxorubicin for male
patients with partners of child bearing potential. Males with pregnant partners
should use condoms during doxorubicin treatment and for at least 10 days after the
last dose of doxorubicin. Contraception measures must also continue for 4 months
after the last dose of pembrolizumab for patients of child bearing potential
- Patient must have the ability to understand and the willingness to sign a written
informed consent document. Patients with impaired decision-making capacity (IDMC)
who have a legally authorized representative (LAR) or caregiver and/or family member
available will also be considered eligible
- Patient must have a left ventricular ejection Fraction (LVEF) > 50% by either MUGA
scan or echocardiogram obtained within 28 days prior to randomization
- Absolute neutrophil count (ANC) ≥ 1,500 cells/m^3 (must be obtained ≤ 7 days prior
to protocol randomization)
- Platelets ≥ 75,000 cells/m^3 (must be obtained ≤ 7 days prior to protocol
randomization)
- Total bilirubin < 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol
randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 ×
institutional ULN (must be obtained ≤ 7 days prior to protocol randomization)
- Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (must be
obtained ≤ 7 days prior to protocol randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of randomization are eligible
for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if follow-up brain imaging after
central nervous system (CNS)-directed therapy shows no evidence of progression
- Patients with new or progressive brain metastases (active brain metastases) or
leptomeningeal disease are eligible if the treating physician determines that
immediate CNS specific treatment is not required and is unlikely to be required
during the first cycle of therapy
- 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
- 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
- Patient must not have a history of or active interstitial lung disease
- Patient must have measurable disease. Baseline imaging must include a chest CT.
Imaging should in inclusive of all measurable and non-measurable disease and must be
obtained within 28 days prior to randomization. Imaging must be available for
uploading to TRIAD
- NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable,
CT portion of positron emission tomography (PET) may be acceptable. Magnetic
Resonance Imaging (MRI) is acceptable for measuring other sites of disease
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
0-1
- Patient must not have had prior treatment with an anthracycline
- Patient must not have a diagnosis of clinically significant immunodeficiency or an
autoimmune disorder requiring the patient to use systemic steroid chronically, or
systemic steroids within 7 days prior to randomization
- Patient must not have a known history of active TB (Bacillus Tuberculosis)
- Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or
any of their excipients
- Patients who have received prior chemotherapy, targeted small molecule therapy or
radiation therapy must have recovered from the prior therapy at the time of
randomization
- Patient must have recovered adequately from any prior major surgery prior to
randomization
- Patient must not have had prior pericardial or mediastinal radiation
- Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1,
anti-PD-L2 or anti-CTLA4 agent
- Patient must not have an autoimmune or other disease that requires the use of daily
corticosteroids of > 10 mg of prednisone (or equivalent). Patients who are on an
active steroid taper at the time of randomization must finish prior to beginning
study treatment. Patients who require inhaled or topical steroids are eligible
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Keck Medicine of USC Koreatown
Address:
City:
Los Angeles
Zip:
90020
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
213-388-0908
Investigator:
Last name:
James S. Hu
Email:
Principal Investigator
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Email:
uscnorrisinfo@med.usc.edu
Investigator:
Last name:
James S. Hu
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Investigator:
Last name:
James S. Hu
Email:
Principal Investigator
Facility:
Name:
USC Norris Oncology/Hematology-Newport Beach
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Investigator:
Last name:
James S. Hu
Email:
Principal Investigator
Facility:
Name:
Beebe South Coastal Health Campus
Address:
City:
Millville
Zip:
19967
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-291-6730
Email:
research@beebehealthcare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Helen F Graham Cancer Center
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-623-4450
Email:
lbarone@christianacare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Medical Oncology Hematology Consultants PA
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-623-4450
Email:
lbarone@christianacare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Beebe Health Campus
Address:
City:
Rehoboth Beach
Zip:
19971
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-291-6730
Email:
research@beebehealthcare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Kootenai Health - Coeur d'Alene
Address:
City:
Coeur d'Alene
Zip:
83814
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Kootenai Clinic Cancer Services - Post Falls
Address:
City:
Post Falls
Zip:
83854
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Kootenai Clinic Cancer Services - Sandpoint
Address:
City:
Sandpoint
Zip:
83864
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Bloomington
Address:
City:
Bloomington
Zip:
61704
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Canton
Address:
City:
Canton
Zip:
61520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Carthage
Address:
City:
Carthage
Zip:
62321
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Centralia Oncology Clinic
Address:
City:
Centralia
Zip:
62801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
University of Chicago Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Daniel J. Olson
Email:
Principal Investigator
Facility:
Name:
Carle at The Riverfront
Address:
City:
Danville
Zip:
61832
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@Carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Cancer Care Specialists of Illinois - Decatur
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Kishwaukee
Address:
City:
DeKalb
Zip:
60115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Dixon
Address:
City:
Dixon
Zip:
61021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
815-285-7800
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Effingham
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Crossroads Cancer Center
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Elmhurst Memorial Hospital
Address:
City:
Elmhurst
Zip:
60126
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-758-5460
Email:
Jrohde@emhc.org
Investigator:
Last name:
Samir D. Undevia
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Eureka
Address:
City:
Eureka
Zip:
61530
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Galesburg
Address:
City:
Galesburg
Zip:
61401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Delnor
Address:
City:
Geneva
Zip:
60134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Glenview Outpatient Center
Address:
City:
Glenview
Zip:
60026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1102
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Grayslake Outpatient Center
Address:
City:
Grayslake
Zip:
60030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1102
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Kewanee Clinic
Address:
City:
Kewanee
Zip:
61443
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Lake Forest Hospital
Address:
City:
Lake Forest
Zip:
60045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
cancertrials@northwestern.edu
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Macomb
Address:
City:
Macomb
Zip:
61455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Mattoon/Charleston
Address:
City:
Mattoon
Zip:
61938
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Edward Hospital/Cancer Center
Address:
City:
Naperville
Zip:
60540
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-646-6075
Investigator:
Last name:
Samir D. Undevia
Email:
Principal Investigator
Facility:
Name:
UC Comprehensive Cancer Center at Silver Cross
Address:
City:
New Lenox
Zip:
60451
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Daniel J. Olson
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Orland Park
Address:
City:
Orland Park
Zip:
60462
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
nctnprogram_rhlccc@northwestern.edu
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
University of Chicago Medicine-Orland Park
Address:
City:
Orland Park
Zip:
60462
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Daniel J. Olson
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Ottawa Clinic
Address:
City:
Ottawa
Zip:
61350
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Pekin
Address:
City:
Pekin
Zip:
61554
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Peoria
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Peru
Address:
City:
Peru
Zip:
61354
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Edward Hospital/Cancer Center?Plainfield
Address:
City:
Plainfield
Zip:
60585
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-646-6075
Email:
Cancerresearch@edward.org
Investigator:
Last name:
Samir D. Undevia
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare-Princeton
Address:
City:
Princeton
Zip:
61356
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Southern Illinois University School of Medicine
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-545-7929
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Clinic
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-444-7541
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Memorial Hospital
Address:
City:
Springfield
Zip:
62781
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-528-7541
Email:
pallante.beth@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Suparna Mantha
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Warrenville
Address:
City:
Warrenville
Zip:
60555
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
630-352-5360
Email:
Donald.Smith3@nm.org
Investigator:
Last name:
Seth M. Pollack
Email:
Principal Investigator
Facility:
Name:
Illinois CancerCare - Washington
Address:
City:
Washington
Zip:
61571
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
309-243-3605
Email:
andersonj@illinoiscancercare.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
UChicago Medicine Northwest Indiana
Address:
City:
Crown Point
Zip:
46307
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Daniel J. Olson
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Ankeny
Address:
City:
Ankeny
Zip:
50023
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-282-2921
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Saint Anthony Regional Hospital
Address:
City:
Carroll
Zip:
51401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-689-7658
Email:
sbenson@iora.org
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Des Moines
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Broadlawns Medical Center
Address:
City:
Des Moines
Zip:
50314
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-282-2200
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Trinity Regional Medical Center
Address:
City:
Fort Dodge
Zip:
50501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-574-8302
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
University of Iowa/Holden Comprehensive Cancer Center
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-237-1225
Investigator:
Last name:
John M. Rieth
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-442-3324
Investigator:
Last name:
Candace L. Haddox
Email:
Principal Investigator
Facility:
Name:
Essentia Health - Deer River Clinic
Address:
City:
Deer River
Zip:
56636
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-786-3308
Email:
CancerTrials@EssentiaHealth.org
Investigator:
Last name:
Bret E. Friday
Email:
Principal Investigator
Facility:
Name:
Essentia Health Cancer Center
Address:
City:
Duluth
Zip:
55805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-786-3308
Email:
CancerTrials@EssentiaHealth.org
Investigator:
Last name:
Bret E. Friday
Email:
Principal Investigator
Facility:
Name:
Essentia Health Hibbing Clinic
Address:
City:
Hibbing
Zip:
55746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-786-3308
Investigator:
Last name:
Bret E. Friday
Email:
Principal Investigator
Facility:
Name:
Essentia Health Sandstone
Address:
City:
Sandstone
Zip:
55072
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-786-3308
Email:
CancerTrials@EssentiaHealth.org
Investigator:
Last name:
Bret E. Friday
Email:
Principal Investigator
Facility:
Name:
Essentia Health Virginia Clinic
Address:
City:
Virginia
Zip:
55792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-786-3308
Email:
CancerTrials@EssentiaHealth.org
Investigator:
Last name:
Bret E. Friday
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Brian A. Van Tine
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center-South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Brian A. Van Tine
Email:
Principal Investigator
Facility:
Name:
Billings Clinic Cancer Center
Address:
City:
Billings
Zip:
59101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-996-2663
Email:
research@billingsclinic.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Bozeman Health Deaconess Hospital
Address:
City:
Bozeman
Zip:
59715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Benefis Sletten Cancer Institute
Address:
City:
Great Falls
Zip:
59405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Community Medical Center
Address:
City:
Missoula
Zip:
59804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Nebraska Medicine-Bellevue
Address:
City:
Bellevue
Zip:
68123
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Omar K. Abughanimeh
Email:
Principal Investigator
Facility:
Name:
Nebraska Medicine-Village Pointe
Address:
City:
Omaha
Zip:
68118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-5600
Investigator:
Last name:
Omar K. Abughanimeh
Email:
Principal Investigator
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Omar K. Abughanimeh
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Investigator:
Last name:
Ajay Gupta
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-275-3853
Investigator:
Last name:
Richard F. Riedel
Email:
Principal Investigator
Facility:
Name:
UH Seidman Cancer Center at UH Avon Health Center
Address:
City:
Avon
Zip:
44011
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Investigator:
Last name:
Ankit Mangla
Email:
Principal Investigator
Facility:
Name:
UHHS-Chagrin Highlands Medical Center
Address:
City:
Beachwood
Zip:
44122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Ankit Mangla
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital South
Address:
City:
Centerville
Zip:
45459
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Case Western Reserve University
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Ankit Mangla
Email:
Principal Investigator
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-293-5066
Email:
Jamesline@osumc.edu
Investigator:
Last name:
Marium Husain
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital
Address:
City:
Dayton
Zip:
45409
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Premier Blood and Cancer Center
Address:
City:
Dayton
Zip:
45409
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-276-8320
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital North
Address:
City:
Dayton
Zip:
45415
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Atrium Medical Center-Middletown Regional Hospital
Address:
City:
Franklin
Zip:
45005-1066
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Miami Valley Cancer Care and Infusion
Address:
City:
Greenville
Zip:
45331
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-569-7515
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Upper Valley Medical Center
Address:
City:
Troy
Zip:
45373
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Minh Phan
Email:
Principal Investigator
Facility:
Name:
Pennsylvania Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-216-0098
Email:
PennCancerTrials@careboxhealth.com
Investigator:
Last name:
Daniel Lefler
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
CTOclinops@vcu.edu
Investigator:
Last name:
Andrew Poklepovic
Email:
Principal Investigator
Facility:
Name:
Duluth Clinic Ashland
Address:
City:
Ashland
Zip:
54806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-786-3308
Email:
CancerTrials@EssentiaHealth.org
Investigator:
Last name:
Bret E. Friday
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
414-805-3666
Investigator:
Last name:
John A. Charlson
Email:
Principal Investigator
Facility:
Name:
ProHealth D N Greenwald Center
Address:
City:
Mukwonago
Zip:
53149
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
research.institute@phci.org
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Facility:
Name:
ProHealth Oconomowoc Memorial Hospital
Address:
City:
Oconomowoc
Zip:
53066
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
262-928-7878
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Facility:
Name:
ProHealth Waukesha Memorial Hospital
Address:
City:
Waukesha
Zip:
53188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
262-928-7632
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Facility:
Name:
UW Cancer Center at ProHealth Care
Address:
City:
Waukesha
Zip:
53188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
262-928-5539
Email:
Chanda.miller@phci.org
Investigator:
Last name:
Timothy R. Wassenaar
Email:
Principal Investigator
Start date:
September 11, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06422806
