Trial Title:
Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
NCT ID:
NCT06325683
Condition:
Recurrent Glioblastoma
Conditions: Official terms:
Glioblastoma
Recurrence
Nivolumab
Relatlimab
Lomustine
Immunoglobulins
Immunoglobulin G
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Arm I (nivolumab, relatlimab)
Arm group label:
Arm II (lomustine)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (nivolumab, relatlimab)
Arm group label:
Arm II (lomustine)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Lomustine
Description:
Given PO
Arm group label:
Arm II (lomustine)
Other name:
1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
Other name:
1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
Other name:
Belustin
Other name:
Belustine
Other name:
CCNU
Other name:
Cecenu
Other name:
CeeNU
Other name:
Chloroethylcyclohexylnitrosourea
Other name:
Citostal
Other name:
Gleostine
Other name:
Lomeblastin
Other name:
Lomustinum
Other name:
Lucostin
Other name:
Lucostine
Other name:
N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea
Other name:
Prava
Other name:
RB-1509
Other name:
WR-139017
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm I (nivolumab, relatlimab)
Arm group label:
Arm II (lomustine)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Given IV
Arm group label:
Arm I (nivolumab, relatlimab)
Other name:
ABP 206
Other name:
BCD-263
Other name:
BMS 936558
Other name:
BMS-936558
Other name:
BMS936558
Other name:
CMAB819
Other name:
MDX 1106
Other name:
MDX-1106
Other name:
MDX1106
Other name:
NIVO
Other name:
Nivolumab Biosimilar ABP 206
Other name:
Nivolumab Biosimilar BCD-263
Other name:
Nivolumab Biosimilar CMAB819
Other name:
ONO 4538
Other name:
ONO-4538
Other name:
ONO4538
Other name:
Opdivo
Intervention type:
Biological
Intervention name:
Relatlimab
Description:
Given IV
Arm group label:
Arm I (nivolumab, relatlimab)
Other name:
BMS 986016
Other name:
BMS-986016
Other name:
BMS986016
Other name:
Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo surgery
Arm group label:
Arm I (nivolumab, relatlimab)
Arm group label:
Arm II (lomustine)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgery, NOS
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
Summary:
This phase II trial compares the safety, side effects and effectiveness of anti-lag-3
(relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the
treatment of patients with glioblastoma that has come back after a period of improvement
(recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with
the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a
class of medications called alkylating agents. It damages the cell's deoxyribonucleic
acid (DNA) and may kill cancer cells. Relatlimab and nivolumab may be safe, tolerable,
and/or effective compared to standard of care lomustine in treating patients with
recurrent glioblastoma.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare the restricted mean survival time (RMST) for overall survival (OS) between
patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus
patients receiving standard of care chloroethylcyclohexylnitrosourea (CCNU) (lomustine).
SECONDARY OBJECTIVES:
I. To compare the 12-month OS rates between patients receiving the combination of
relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU
(lomustine).
II. To compare the restricted mean survival times for progression-free survival (PFS)
between patients receiving the combination of relatlimab (BMS-986016) and nivolumab
versus patients receiving standard of care CCNU (lomustine).
III. To compare the radiographic response rate between patients receiving the combination
of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU
(lomustine).
IV. To compare the safety/adverse event rate between patients receiving the combination
of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU
(lomustine).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes followed by
relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Additionally, patients undergo
surgery or biopsy, magnetic resonance imaging (MRI), and blood sample collection
throughout study.
ARM II: Patients receive lomustine orally (PO) on day 1 of each cycle. Cycles repeat
every 42 days in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection
throughout study.
After completion of study treatment, patients are followed up every 6 months for up to 5
years from time of randomization.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically-proven glioblastoma (World Health Organization [WHO] 2021 criteria)
- Progressive or recurrent disease per Response Assessment in Neuro-Oncology (RANO)
criteria
- No IDH mutation (IDH1 R132H negative by immunohistochemistry [IHC] or sequencing)
- Patients must be in first recurrence of glioblastoma following radiation therapy and
temozolomide
- No prior therapies except radiation, surgery, temozolomide, Tumor Treating Fields
(TTFields), and/or Gliadel wafers (placed during the first surgery at diagnosis of
glioblastoma multiforme [GBM]). Prior radiation therapy, TTFields, or placement of
Gliadel wafers must be completed at least 12 weeks prior to registration. Prior
temozolomide must be completed at least 3 weeks prior to registration
- No prior use of nivolumab or other anti-PD1 agents
- Patients must be neurologically stable off corticosteroids for at least 5 days prior
to registration
- Age: ≥ 18 years
- Karnofsky Performance Status: ≥ 60% (i.e. patient must be able to care for
themselves with occasional help from others)
- Absolute lymphocyte count (ALC): ≥ 1000/mm^3
- Absolute neutrophil count (ANC): ≥ 1500/mm^3
- Platelet count: ≥ 100,000/mm^3
- Hemoglobin: ≥ 9.0 g/dL
- Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT): ≤
1.5 x upper limit of normal (ULN)
- Total bilirubin: < 2.0 x ULN (Except for patients with Gilbert's syndrome, who must
have direct bilirubin < 2.0 x ULN)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT): < 3.0 x ULN
- Calculated (calc.) creatinine clearance (CrCl): ≥ 50 mL/min/1.73m^2
- Thyroid-stimulating hormone (TSH): within normal limits (WNL) (Supplementation is
acceptable to achieve a TSH WNL. In patients with abnormal TSH, if Free T4 is normal
and patient is clinically euthyroid, patient is eligible)
- 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 and an agent that has known genotoxic, mutagenic and teratogenic
effects. Therefore, for women of childbearing potential only, a negative pregnancy
test done within 14 days prior to registration is required
- 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
- No active brain metastases or leptomeningeal disease
- HIV: HIV-infected patients on effective anti-retroviral therapy with undetectable
viral load within 6 months prior to registration are eligible for this trial
- Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV)
infection, the HBV viral load must be undetectable on suppressive therapy, if
indicated
- Hepatitis C: 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
- No known medical condition causing an inability to swallow oral formulations of
agents
- No current symptomatic pulmonary disease
- No autoimmune disorders that require systemic treatment (except hyperthyroidism or
diabetes mellitus)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
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:
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:
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:
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:
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:
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:
NorthShore University HealthSystem-Evanston Hospital
Address:
City:
Evanston
Zip:
60201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
847-570-2109
Investigator:
Last name:
Christopher R. Trevino
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:
NorthShore University HealthSystem-Glenbrook Hospital
Address:
City:
Glenview
Zip:
60026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
847-570-2109
Investigator:
Last name:
Christopher R. Trevino
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:
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:
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:
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:
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:
Mary Greeley Medical Center
Address:
City:
Ames
Zip:
50010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-956-4132
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
McFarland Clinic - Ames
Address:
City:
Ames
Zip:
50010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-239-4734
Email:
ksoder@mcfarlandclinic.com
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
McFarland Clinic - Boone
Address:
City:
Boone
Zip:
50036
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-956-4132
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
319-365-4673
Investigator:
Last name:
Deborah W. Wilbur
Email:
Principal Investigator
Facility:
Name:
Oncology Associates at Mercy Medical Center
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
319-363-2690
Investigator:
Last name:
Deborah W. Wilbur
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - West Des Moines
Address:
City:
Clive
Zip:
50325
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Richard L. Deming
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Laurel
Address:
City:
Des Moines
Zip:
50314
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Richard L. Deming
Email:
Principal Investigator
Facility:
Name:
McFarland Clinic - Trinity Cancer Center
Address:
City:
Fort Dodge
Zip:
50501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-956-4132
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
McFarland Clinic - Jefferson
Address:
City:
Jefferson
Zip:
50129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-956-4132
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
McFarland Clinic - Marshalltown
Address:
City:
Marshalltown
Zip:
50158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-956-4132
Investigator:
Last name:
Joseph J. Merchant
Email:
Principal Investigator
Facility:
Name:
University of Kentucky/Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
859-257-3379
Investigator:
Last name:
John L. Villano
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Address:
City:
Ann Arbor
Zip:
48106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Address:
City:
Brighton
Zip:
48114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Canton
Address:
City:
Canton
Zip:
48188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Address:
City:
Chelsea
Zip:
48118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Genesee Cancer and Blood Disease Treatment Center
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Genesee Hematology Oncology PC
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Genesys Hurley Cancer Institute
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Hurley Medical Center
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
University of Michigan Health - Sparrow Lansing
Address:
City:
Lansing
Zip:
48912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
517-364-3712
Email:
harsha.trivedi@umhsparrow.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Mary Mercy Livonia Hospital
Address:
City:
Livonia
Zip:
48154
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Address:
City:
Ypsilanti
Zip:
48197
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Elie G. Dib
Email:
Principal Investigator
Facility:
Name:
Essentia Health Saint Joseph's Medical Center
Address:
City:
Brainerd
Zip:
56401
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 - 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:
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:
Morristown Medical Center
Address:
City:
Morristown
Zip:
07960
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
973-971-5900
Investigator:
Last name:
Robert D. Aiken
Email:
Principal Investigator
Facility:
Name:
Overlook Hospital
Address:
City:
Summit
Zip:
07902
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
908-522-2043
Investigator:
Last name:
Robert D. Aiken
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
718-379-6866
Email:
eskwak@montefiore.org
Investigator:
Last name:
Adilia M. Hormigo
Email:
Principal Investigator
Facility:
Name:
FirstHealth of the Carolinas-Moore Regional Hospital
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
910-715-3500
Email:
jcwilliams@firsthealth.org
Investigator:
Last name:
Charles S. Kuzma
Email:
Principal Investigator
Facility:
Name:
Essentia Health Cancer Center-South University Clinic
Address:
City:
Fargo
Zip:
58103
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:
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:
Pawan K. Singh
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
Start date:
May 31, 2025
Completion date:
July 15, 2028
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/NCT06325683
