Trial Title:
Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer
NCT ID:
NCT05904080
Condition:
Metastatic Nasopharyngeal Carcinoma
Recurrent Nasopharyngeal Carcinoma
Stage IV Nasopharyngeal Carcinoma AJCC v8
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Nivolumab
Ipilimumab
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:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm A (nivolumab, ipilimumab)
Arm group label:
Arm B (nivolumab, ipilimumab, cabozantinib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Cabozantinib S-malate
Description:
Given PO
Arm group label:
Arm B (nivolumab, ipilimumab, cabozantinib)
Other name:
BMS-907351
Other name:
Cabometyx
Other name:
Cometriq
Other name:
XL 184
Other name:
XL-184
Other name:
XL184
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Arm A (nivolumab, ipilimumab)
Arm group label:
Arm B (nivolumab, ipilimumab, cabozantinib)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Biological
Intervention name:
Ipilimumab
Description:
Given IV
Arm group label:
Arm A (nivolumab, ipilimumab)
Arm group label:
Arm B (nivolumab, ipilimumab, cabozantinib)
Other name:
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
Other name:
BMS 734016
Other name:
BMS-734016
Other name:
BMS734016
Other name:
Ipilimumab Biosimilar CS1002
Other name:
MDX 010
Other name:
MDX-010
Other name:
MDX-CTLA4
Other name:
MDX010
Other name:
Yervoy
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm A (nivolumab, ipilimumab)
Arm group label:
Arm B (nivolumab, ipilimumab, cabozantinib)
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 A (nivolumab, ipilimumab)
Arm group label:
Arm B (nivolumab, ipilimumab, cabozantinib)
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
Summary:
This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without
cabozantinib works in treating patients with nasopharyngeal cancer that has come back
(after a period of improvement) (recurrent), has spread from where it first started
(primary site) to other places in the body (metastatic), or for which no treatment is
currently available (incurable). 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. Cabozantinib is in a class
of medications called kinase inhibitors. It works by blocking the action of an abnormal
protein that signals cancer cells to multiply. This helps slow or stop the spread of
cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy
with cabozantinib may help shrink and stabilize nasopharyngeal cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine if the progression-free survival (PFS) of the triplet combination
(cabozantinib S-malate, nivolumab, and ipilimumab [CaboNivoIpi]) is more favorable than
the doublet (nivolumab and ipilimumab [NivoIpi]).
SECONDARY OBJECTIVES:
I. To compare safety and tolerability between the two arms (Common Terminology Criteria
for Adverse Events [CTCAE] version [v]5.0.).
II. To compare overall response rate (ORR) between the two arms via both Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune-modified Response Evaluation
Criteria in Solid Tumors (iRECIST) criteria.
III. To compare overall survival (OS) between the two arms. IV. To assess response by
primary or acquired PD-1/L1 inhibitor resistance in the prior line of therapy.
EXPLORATORY OBJECTIVE:
I. To evaluate molecular and immunologic predictors of response (Epstein-Barr virus [EBV]
viral load; PD-L1 score) between arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV
over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 2 years in
the absence of disease progression or unacceptable toxicity. Patients undergo computed
tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples
throughout the trial.
ARM B: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on
day 1 and cabozantinib S-malate orally (PO) daily on days 1-28 of each cycle. Cycles
repeat every 28 days for up to 2 years in the absence of disease progression or
unacceptable toxicity. Patients may continue with cabozantinib S-malate after 2 years per
treating investigator. Patients undergo CT or MRI and collection of blood samples
throughout the trial.
After completion of study treatment, patients are followed up every 8-12 weeks until
progression of disease occurs or a new non-protocol anti-cancer therapy is initiated and
then every 6 months for up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have histologically documented nasopharyngeal carcinoma (NPC)
regardless of World Health Organization (WHO) classification (keratinizing squamous
cell carcinoma, non-keratinizing, or basaloid squamous cell carcinoma) and
regardless of association with Epstein-Barr virus (EBV) and/or human papillomavirus
(HPV)
- Recurrent, metastatic and incurable disease treated with platinum-gemcitabine and
prior PD-1/L1 blockade (as first or second-line therapy) where immunotherapy was
part of the most recent prior line of therapy
- Patients are eligible regardless of prior smoking history, p16 immunohistochemistry
(IHC) status, PD-L1 expression status, EBV tumor status, EBV viral load at baseline,
or tumor genomic alteration status
- Patients must have at least one measurable lesion (by RECIST v1.1) which has not
been previously irradiated that can be accurately measured in at least one dimension
(longest diameter to be recorded for non-nodal lesions as >= 10 mm (>= 1 cm) (and
short axis for nodal lesions, LN >= 15 mm) with CT scan, MRI, or calipers by
clinical exam
- Patients may have had no more than 2 prior lines of prior systemic therapy for
recurrent, metastatic NPC
- No prior VEGFR targeted therapy permitted
- Age >= 18 years
- Eastern Cooperative Oncology Group Performance (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Hemoglobin >= 9 g/dL
- Platelet count >= 100,000/mm^3
- Creatinine or creatinine clearance =< 1.5 mg/dL or >= 30 Modification of Diet in
Renal Disease (MDRD)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); except subjects
with Gilbert syndrome who can have a total bilirubin < 3 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGT])
=< 3 x upper limit of normal (ULN)
- Up to =< 5 allowed with liver metastases
- 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
urine or serum pregnancy test, per institution standard, done =< 7 days prior to
registration is required.
- Pregnant women are excluded from this study because nivolumab, ipilimumab, and
cabozantinib are all Class C or D agents with the potential for teratogenic or
abortifacient effects. Because there is an unknown but potential risk for
adverse events in nursing infants, secondary to treatment of the mother with
any of the study agents, breastfeeding should be discontinued if the mother is
treated with as part of this study (in either arm)
- No active tumor bleeding: or radiographic evidence of major blood vessel
infiltration as judged by the treating investigator
- Prior -anti-cancer therapy is allowed: Patients need to be recovered from adverse
events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1),
with the exception of alopecia. Any life-threatening events clearly attributable to
prior immunotherapy exposure that have a high possibility of recurring should
warrant exclusion: including severe pneumonitis, grade 4 bullous dermatitis/drug
reaction with eosinophilia and systemic symptoms (DRESS), neurologic events such as
autoimmune encephalitis transverse myelitis, and/or myocarditis. Maintenance
hormonal replacement or long-term hormonal therapy exposure is permitted.
- No chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or
mitomycin C) prior to registration. Palliative (limited-field) radiation
therapy is permitted, if all of the following criteria are met:
- Repeat imaging demonstrates no new sites of bone metastases.
- The lesion being considered for palliative radiation is not a target
lesion
- No patients with a prior malignancy whose natural history or treatment has the
potential to interfere with the safety or efficacy assessment of the investigational
regimen
- Brain metastases allowed: Patients with treated brain metastases are eligible if
follow-up brain imaging 3 weeks 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
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months prior to registration are
eligible for this trial
- For patients with evidence of chronic hepatitis B (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 receiving
treatment, they are eligible if they have an undetectable HCV viral load
- Solid organ or tissue transplant is allowed: - subsequent therapy with nivolumab
increases the risk of organ/tissue rejection. Patients must be instructed that it is
crucial they stay in touch with their transplant team during treatment
- No active autoimmune disease: or history of autoimmune disease that might recur, and
which may affect vital organ function or require immune suppressive treatment
including systemic corticosteroids. These include but are not limited to patients
with a history of
- Immune related neurologic disease,
- Multiple sclerosis,
- Autoimmune (demyelinating) neuropathy,
- Guillain-Barre syndrome (GBS),
- Myasthenia gravis;
- Systemic autoimmune disease such as SLE,
- Connective tissue diseases,
- Scleroderma, inflammatory bowel disease (IBD),
- Crohn's, ulcerative colitis,
- Patients with a history of toxic epidermal necrolysis (TEN),
- Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because
of the risk of recurrence or exacerbation of disease
- Patients with vitiligo, endocrine deficiencies including thyroiditis managed with
replacement hormones including physiologic corticosteroids are eligible
- Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome, and
psoriasis controlled with topical medication and patients with only positive
serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be
evaluated for the presence of target organ involvement and potential need for
systemic treatment but should otherwise be eligible
- Pneumonitis should be evaluated for the nature of the disease process, need for
treatment prior study treatment, and the risk of exacerbation with study treatment
- Able to swallow oral medication: No known medical condition causing an inability to
swallow oral formulations of agents
- No condition requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of
study registration. Patients are permitted the use of topical, ocular,
intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic
absorption). Adrenal replacement steroid doses > 10 mg daily prednisone are
permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis
(e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g.,
delayed-type hypersensitivity reaction caused by a contact allergen) is permitted
- Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin
inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet
inhibitors (e.g., clopidogrel) is prohibited. Allowed anticoagulants are the
following:
- Prophylactic use of low-dose aspirin for cardio-protection (per local
applicable guidelines) and low-dose low molecular weight heparins (LMWH).
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors
rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases
who are on a stable dose of the anticoagulant for at least 1 week before first
dose of study treatment without clinically significant hemorrhagic
complications from the anticoagulation regimen or the tumor
- Concomitant use of any medications or substances that are strong inhibitors or
inducers of CYP3A4 is discouraged; if unavoidable, the dose of cabozantinib on study
should be adjusted accordingly. Any complementary medications (e.g., herbal
supplements or traditional Chinese medicines) intended to treat the disease under
study are prohibited
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Address:
City:
Irvine
Zip:
92612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Shirin Attarian
Email:
Principal Investigator
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:
Jacob S. Thomas
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:
Jacob S. Thomas
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:
Jacob S. Thomas
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:
Jacob S. Thomas
Email:
Principal Investigator
Facility:
Name:
UC Irvine Health/Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Shirin Attarian
Email:
Principal Investigator
Facility:
Name:
Saint Alphonsus Cancer Care Center-Boise
Address:
City:
Boise
Zip:
83706
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-3671
Email:
stephanie.couch@stjoeshealth.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Saint Alphonsus Cancer Care Center-Caldwell
Address:
City:
Caldwell
Zip:
83605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-3671
Email:
stephanie.couch@stjoeshealth.org
Investigator:
Last name:
John M. Schallenkamp
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:
Saint Alphonsus Cancer Care Center-Nampa
Address:
City:
Nampa
Zip:
83687
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:
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:
Jochen H. Lorch
Email:
Principal Investigator
Facility:
Name:
University of Illinois
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-355-3046
Investigator:
Last name:
Ameen Salahudeen
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:
Ari J. Rosenberg
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:
Prem Sobti
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:
Jochen H. Lorch
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:
Prem Sobti
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:
Jochen H. Lorch
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:
Jochen H. Lorch
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:
Jochen H. Lorch
Email:
Principal Investigator
Facility:
Name:
Ingalls Memorial Hospital
Address:
City:
Harvey
Zip:
60426
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
708-915-4673
Email:
clinicaltrials@ingalls.org
Investigator:
Last name:
James A. Wallace
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:
Jochen H. Lorch
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:
Prem Sobti
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:
Ari J. Rosenberg
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:
Jochen H. Lorch
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:
Ari J. Rosenberg
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:
Prem Sobti
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:
Jochen H. Lorch
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:
Mercy Cancer Center-West Lakes
Address:
City:
Clive
Zip:
50325
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-358-6613
Email:
cancerresearch@mercydesmoines.org
Investigator:
Last name:
Richard L. Deming
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:
Heartland Oncology and Hematology LLP
Address:
City:
Council Bluffs
Zip:
51503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
712-322-4136
Investigator:
Last name:
Yungpo B. Su
Email:
Principal Investigator
Facility:
Name:
Iowa Methodist Medical Center
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-6727
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:
Mercy Medical Center - Des Moines
Address:
City:
Des Moines
Zip:
50314
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-358-6613
Email:
cancerresearch@mercydesmoines.org
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:
Tufts Medical Center
Address:
City:
Boston
Zip:
02111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
617-636-5000
Email:
ContactUsCancerCenter@TuftsMedicalCenter.org
Investigator:
Last name:
Francis W. Nugent
Email:
Principal Investigator
Facility:
Name:
Sanford Joe Lueken Cancer Center
Address:
City:
Bemidji
Zip:
56601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
218-333-5000
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Community Hospital of Anaconda
Address:
City:
Anaconda
Zip:
59711
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:
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:
Logan Health Medical Center
Address:
City:
Kalispell
Zip:
59901
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 Cancer Specialists/Oncology Hematology West PC - MECC
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-334-4773
Investigator:
Last name:
Yungpo B. Su
Email:
Principal Investigator
Facility:
Name:
Oncology Associates PC
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-354-5860
Email:
info@oa-oc.com
Investigator:
Last name:
Yungpo B. Su
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Eric J. Sherman
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-668-0683
Email:
cancerclinicaltrials@med.unc.edu
Investigator:
Last name:
Siddharth Sheth
Email:
Principal Investigator
Facility:
Name:
Sanford Bismarck Medical Center
Address:
City:
Bismarck
Zip:
58501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-323-5760
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford Broadway Medical Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-323-5760
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford Roger Maris Cancer Center
Address:
City:
Fargo
Zip:
58122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
701-234-6161
Email:
OncologyClinicalTrialsFargo@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Good Samaritan Hospital - Cincinnati
Address:
City:
Cincinnati
Zip:
45220
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
720-874-1881
Email:
ResearchInstituteInquiries@CommonSpirit.org
Investigator:
Last name:
Shahzad Siddique
Email:
Principal Investigator
Facility:
Name:
Cancer Centers of Southwest Oklahoma Research
Address:
City:
Lawton
Zip:
73505
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-231-4440
Investigator:
Last name:
Minh Phan
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:
Oklahoma Cancer Specialists and Research Institute-Tulsa
Address:
City:
Tulsa
Zip:
74146
Country:
United States
Status:
Suspended
Facility:
Name:
Saint Alphonsus Cancer Care Center-Ontario
Address:
City:
Ontario
Zip:
97914
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:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-494-1080
Email:
trials@ohsu.edu
Investigator:
Last name:
Chetan Vakkalagadda
Email:
Principal Investigator
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Suspended
Facility:
Name:
Sanford Cancer Center Oncology Clinic
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
605-312-3320
Email:
OncologyClinicTrialsSF@sanfordhealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
Sanford USD Medical Center - Sioux Falls
Address:
City:
Sioux Falls
Zip:
57117-5134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
605-312-3320
Email:
OncologyClinicalTrialsSF@SanfordHealth.org
Investigator:
Last name:
Daniel Almquist
Email:
Principal Investigator
Facility:
Name:
West Virginia University Healthcare
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
304-293-7374
Email:
cancertrialsinfo@hsc.wvu.edu
Investigator:
Last name:
Sidra Najeeb
Email:
Principal Investigator
Facility:
Name:
Camden Clark Medical Center
Address:
City:
Parkersburg
Zip:
26101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
304-293-7374
Email:
cancertrialsinfo@hsc.wvu.edu
Investigator:
Last name:
Sidra Najeeb
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-EC Cancer Center
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Joseph Edmund
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Joseph Edmund
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center - Minocqua
Address:
City:
Minocqua
Zip:
54548
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Joseph Edmund
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-River Region at Stevens Point
Address:
City:
Stevens Point
Zip:
54482
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Joseph Edmund
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center - Weston
Address:
City:
Weston
Zip:
54476
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Joseph Edmund
Email:
Principal Investigator
Start date:
February 19, 2024
Completion date:
June 16, 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/NCT05904080
