Trial Title:
Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial
NCT ID:
NCT05947500
Condition:
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Locally Advanced Merkel Cell Carcinoma
Metastatic Merkel Cell Carcinoma
Refractory Merkel Cell Carcinoma
Unresectable Merkel Cell Carcinoma
Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Avelumab
Antibodies, Monoclonal
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:
Drug
Intervention name:
Avelumab
Description:
Given IV
Arm group label:
Arm 2 (tuvusertib, avelumab)
Other name:
Bavencio
Other name:
MSB 0010718C
Other name:
MSB-0010718C
Other name:
MSB0010718C
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Arm 1 (tuvusertib)
Arm group label:
Arm 2 (tuvusertib, avelumab)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood and stool
Arm group label:
Arm 1 (tuvusertib)
Arm group label:
Arm 2 (tuvusertib, avelumab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT or PET/CT
Arm group label:
Arm 1 (tuvusertib)
Arm group label:
Arm 2 (tuvusertib, avelumab)
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:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm 1 (tuvusertib)
Arm group label:
Arm 2 (tuvusertib, avelumab)
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:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Arm 1 (tuvusertib)
Arm group label:
Arm 2 (tuvusertib, avelumab)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Drug
Intervention name:
Tuvusertib
Description:
Given PO
Arm group label:
Arm 1 (tuvusertib)
Arm group label:
Arm 2 (tuvusertib, avelumab)
Other name:
ATR Kinase Inhibitor M1774
Other name:
M 1774
Other name:
M-1774
Other name:
M1774
Summary:
This phase II trial compares tuvusertib in combination with avelumab to tuvusertib alone
to determine whether the combination therapy will lengthen the time before the cancer
starts getting worse in patients with Merkel cell cancer that has not responded to
previous treatment (refractory). Tuvusertib is a drug that inhibits an enzyme called
ataxia telangiectasia and Rad3 related (ATR) kinase, which is an enzyme that plays a role
in repair of damaged deoxyribonucleic acid (DNA) as well as tumor cell replication and
survival. It may lead to tumor cell death by inhibiting ATR kinase activity.
Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. Giving tuvusertib in combination with avelumab may lengthen the time before
Merkel cell cancer starts getting worse compared to giving avelumab alone.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare the potential efficacy, using progression free survival (PFS), of ATR
inhibition alone to ATR inhibition plus anti-PD-(L)1 therapy through a randomized
clinical trial for patients with advanced Merkel cell carcinoma (MCC) who have progressed
on anti-PD(L)1 therapy.
SECONDARY OBJECTIVES:
I. To compare the clinical activity of ATR inhibition alone to that in combination with
avelumab through a randomized clinical trial for patients with advanced MCC that has
progressed after PD-1 pathway blockade.
II. To identify gene expression-based immunologic (replication stress / neuroendocrine
[NE] differentiation) signatures predictive of response to ATR inhibition in advanced
immunotherapy-refractory MCC tumors through ribonucleic acid sequencing (RNAseq).
EXPLORATORY OBJECTIVES:
I. To examine the association of various biomarkers with the clinical activity of ATR
inhibition alone or in combination with PD-(L)1 pathway blockade.
II. To explore the safety and efficacy (PFS, overall response rate [ORR], and overall
survival [OS]) of the addition of avelumab to M1774 after documented progressive disease
of M1774 monotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive tuvusertib orally (PO) once daily (QD) on days 1-14 of each
cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable
toxicity. Patients also undergo computed tomography (CT), positron emission tomography
(PET)/CT, or magnetic resonance imaging (MRI), biopsy, and collection of blood and
stool/rectal swabs at screening and on study. Patients with documented progression may
cross over to Arm 2.
ARM 2: Patients receive tuvusertib PO QD on days 1-14 of each cycle and avelumab
intravenously (IV) over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in
the absence of disease progression or unacceptable toxicity. Patients also undergo CT,
PET/CT, or MRI, biopsy, and collection of blood and stool at screening and on study.
After completion of study treatment, patients are followed up at 30 days and then every 6
months for 2 years from the last dose of treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- REGISTRATION ELIGIBILITY: Patients must have a history of pathologically confirmed
locally advanced/unresectable Merkel cell carcinoma or metastatic Merkel cell
carcinoma
- REGISTRATION ELIGIBILITY: Patients must have evaluable disease per Response
Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
- REGISTRATION ELIGIBILITY: Patients must have had prior treatment with anti-PD-1 or
anti-PD-L-1 antibody (e.g., pembrolizumab, avelumab, etc.) and have experienced
progressive disease during treatment or within 120 days from the last dose of
anti-PD-(L)1 therapy. Anti-PD-(L)1 therapy administered in combination with other
agent(s) including ipilimumab is also allowed as prior therapy, if patients
experienced progressive disease during treatment or within 120 days from the last
dose of anti-PD-(L)1 therapy. If participants are receiving or received cytotoxic
chemotherapy as most recent therapy prior to screening for this trial, there must be
clinically and/or radiologically documented progressive disease on or after
chemotherapy prior to being eligible for this study. If the patient is receiving
bridging chemotherapy, the most recent administration must be ≥ 14 days prior to
planned cycle 1 day 1 (C1D1) of the clinical trial to be eligible
- REGISTRATION ELIGIBILITY: Age >= 18 years. Because no dosing or adverse event data
are currently available on the use of M1774 in combination with avelumab in patients
< 18 years of age, children are excluded from this study
- REGISTRATION ELIGIBILITY: Eastern Cooperative Oncology Group (ECOG) performance
status =< 2 (Karnofsky >= 60%)
- REGISTRATION ELIGIBILITY: Absolute neutrophil count >= 1,000/mcL
- REGISTRATION ELIGIBILITY: Platelets >= 100,000/mcL
- REGISTRATION ELIGIBILITY: Total bilirubin =< institutional upper limit of normal
(ULN) or ≤ 1.5 x ULN for subjects with Gilbert's disease
- REGISTRATION ELIGIBILITY: Aspartate aminotransferase (AST)(serum
glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum
glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
- REGISTRATION ELIGIBILITY: Creatinine =< institutional ULN
- REGISTRATION ELIGIBILITY: Estimated glomerular filtration rate (eGFR) >= 60
mL/min/1.73 m^2
- REGISTRATION ELIGIBILITY: Hemoglobin >= 9.0 g/dL
- REGISTRATION ELIGIBILITY: Human immunodeficiency virus (HIV)-infected patients on
effective anti-retroviral therapy with undetectable viral load within 6 months are
eligible for this trial
- REGISTRATION ELIGIBILITY: For patients with evidence of chronic hepatitis B virus
(HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if
indicated
- REGISTRATION ELIGIBILITY: 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
- REGISTRATION ELIGIBILITY: Patients with treated brain metastases are eligible if
follow-up brain imaging during screening shows no evidence of progressive brain
metastases and it has been at least 4 weeks since central nervous system (CNS)
directed therapy
- REGISTRATION ELIGIBILITY: 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
- REGISTRATION ELIGIBILITY: 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
- REGISTRATION ELIGIBILITY: The effects of M1774 on the developing human fetus are
unknown. For this reason and because ATR inhibitor agents as well as other
therapeutic agents used in this trial are known to be teratogenic, women of
child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and, for the
duration of study participation, and 6 months after completion of M1774 and avelumab
administration. Should a woman become pregnant or suspect she is pregnant while she
or her partner is participating in this study, she should inform her treating
physician immediately. Men treated or enrolled on this protocol must also agree to
use adequate contraception prior to the study, for the duration of study
participation, and 3 months after completion of M1774 and avelumab administration
- REGISTRATION ELIGIBILITY: Ability to understand and the willingness to sign a
written informed consent document. Legally authorized representatives may sign and
give informed consent on behalf of study participants
- CROSSOVER ELIGIBILITY: Patient was initially assigned to arm 1 (M1774 monotherapy)
and completed at least 21 of 28 possible doses of M1774
- CROSSOVER ELIGIBILITY: Patients must have documented progressive disease per RECIST
v 1.1
- CROSSOVER ELIGIBILITY: ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- CROSSOVER ELIGIBILITY: Absolute neutrophil count ≥ 1,000/mcL (within 14 days of
crossover registration)
- CROSSOVER ELIGIBILITY: Platelets ≥ 100,000/mcL (within 14 days of crossover
registration)
- CROSSOVER ELIGIBILITY: Total bilirubin ≤ institutional upper limit of normal (ULN)
or ≤ 1.5 x ULN for subjects with Gilbert's disease (within 14 days of crossover
registration)
- CROSSOVER ELIGIBILITY: AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN (within 14 days
of crossover registration)
- CROSSOVER ELIGIBILITY: Creatinine ≤ institutional ULN (within 14 days of crossover
registration)
- CROSSOVER ELIGIBILITY: Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73
m^2 (within 14 days of crossover registration)
- CROSSOVER ELIGIBILITY: Hemoglobin ≥ 9.0 g/dL (within 14 days of crossover
registration)
- CROSSOVER ELIGIBILITY: Human immunodeficiency virus (HIV)-infected patients on
effective anti-retroviral therapy with undetectable viral load within 6 months are
eligible for this trial
- CROSSOVER ELIGIBILITY: For patients with evidence of chronic hepatitis B virus (HBV)
infection, the HBV viral load must be undetectable on suppressive therapy, if
indicated
- CROSSOVER ELIGIBILITY: 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
- CROSSOVER ELIGIBILITY: Patients with treated brain metastases are eligible if
follow-up brain imaging during screening shows no evidence of progressive brain
metastases and it has been at least 4 weeks since central nervous system (CNS)
directed therapy
- CROSSOVER ELIGIBILITY: 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
- CROSSOVER ELIGIBILITY: 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
- CROSSOVER ELIGIBILITY: The effects of M1774 on the developing human fetus are
unknown. For this reason and because ATR inhibitor agents as well as other
therapeutic agents used in this trial are known to be teratogenic, women of
child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and, for the
duration of study participation, and 6 months after completion of M1774 and avelumab
administration. Should a woman become pregnant or suspect she is pregnant while she
or her partner is participating in this study, she should inform her treating
physician immediately. Men treated or enrolled on this protocol must also agree to
use adequate contraception prior to the study, for the duration of study
participation, and 3 months after completion of M1774 and avelumab administration
Exclusion Criteria:
- REGISTRATION EXCLUSION: Patients with life-threatening immune-related adverse events
(IRAEs) related to prior anti-PD-(L)1 antibody. Patients with a history of IRAE of
grade 4 (G4) severity (excluding thyroid or endocrine disorders now controlled) or
IRAE of any severity that required permanent treatment discontinuation with prior
immune checkpoint inhibitor (ICI) therapy due to toxicity
- REGISTRATION EXCLUSION: Patients with a prior history of ataxia telangiectasia
- REGISTRATION EXCLUSION: Patients who are receiving any other investigational agents
- REGISTRATION EXCLUSION: History of allergic reactions attributed to compounds of
similar chemical or biologic composition to M1774 or avelumab
- REGISTRATION EXCLUSION: Patients with uncontrolled intercurrent illness or any other
significant condition(s) that would make participation in this protocol unreasonably
hazardous
- REGISTRATION EXCLUSION: Pregnant women are excluded from this study because M1774
and avelumab have 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 M1774 and avelumab breastfeeding should be
discontinued if the mother is treated with M1774 or avelumab and for at least 1
month after the last dose of study medications. These potential risks may also apply
to other agents used in this study
- REGISTRATION EXCLUSION: Patients who are not able to swallow orally administered
medication or have gastrointestinal disorders likely to interfere with absorption of
the study medication
- REGISTRATION EXCLUSION: Patients who cannot discontinue proton-pump inhibitors
(PPIs)
- REGISTRATION EXCLUSION: Patients who have not recovered from adverse events due to
prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the
exception of alopecia and neuropathy, which may be =< grade 2. Patients with
endocrinopathies requiring hormone replacement (such as hypothyroidism, autoimmune
diabetes mellitus, adrenal insufficiency) will be allowed
- REGISTRATION EXCLUSION: M1774 is primarily metabolized by aldehyde oxidase and to a
lesser extent CYP3A4 and CYP1A2; therefore, concomitant administration with strong
inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir,
indinavir, nelfinavir and saquinavir) and CYP1A2 or inducers of CYP3A4 (e.g.
rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) and CYP1A2 are
prohibited. M1774 is an inhibitor of MATE1 and MATE2K and substrates of these
transporters are also prohibited. These include metformin, acyclovir, estrone
sulfate, ciprofloxacin and cephalexin. Patients who are taking such medications who
cannot discontinue or switch them to an acceptable alternative are not eligible
- Because the lists of these agents are constantly changing, it is important to
regularly consult a frequently-updated medical reference for a list of drugs to
avoid or minimize use of. One example of such a reference is here
(https://go.drugbank.com/categories/DBCAT003956)
- As part of the enrollment/informed consent procedures, the patient will be
counseled on the risk of interactions with other agents, and what to do if new
medications need to be prescribed or if the patient is considering a new
over-the-counter medicine or herbal product
- REGISTRATION EXCLUSION: Patients who are on chronic corticosteroid treatment
exceeding 10 mg prednisone daily (or equivalent) are excluded. Chronic
corticosteroid use lower than this range is permitted
- REGISTRATION EXCLUSION: Patients with a QTcF (using the Fridericia correction
calculation) of > 470 msec
- CROSSOVER EXCLUSION: Patients with life-threatening immune-related adverse events
(IRAEs) related to prior anti-PD-(L)1 antibody. Patients with a history of IRAE of
G4 severity (excluding thyroid or endocrine disorders now controlled) or IRAE of any
severity that required permanent treatment discontinuation with prior ICI therapy
due to toxicity
- CROSSOVER EXCLUSION: Patients with a prior history of ataxia telangiectasia.
- CROSSOVER EXCLUSION: Patients who are receiving any other investigational agents
- CROSSOVER EXCLUSION: History of allergic reactions attributed to compounds of
similar chemical or biologic composition to M1774 or avelumab
- CROSSOVER EXCLUSION: Patients with uncontrolled intercurrent illness or any other
significant condition(s) that would make participation in this protocol unreasonably
hazardous
- CROSSOVER EXCLUSION: Pregnant women are excluded from this study because M1774 and
avelumab have 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 M1774 and avelumab breastfeeding should be discontinued
if the mother is treated with M1774 or avelumab and for at least 1 month after the
last dose of study medications. These potential risks may also apply to other agents
used in this study
- CROSSOVER EXCLUSION: Patients who are not able to swallow orally administered
medication or have gastrointestinal disorders likely to interfere with absorption of
the study medication
- CROSSOVER EXCLUSION: Patients who cannot discontinue proton-pump inhibitors (PPIs)
- CROSSOVER EXCLUSION: Patients who have not recovered from adverse events due to
prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the
exception of alopecia and neuropathy which may be ≤ grade 2. Additionally, anemia
felt related to M1774 may be grade 2 as long as it exceeds requirement of hemoglobin
> 9 g/dL. Patients with endocrinopathies requiring hormone replacement (such as
hypothyroidism, autoimmune diabetes mellitus, adrenal insufficiency) will be allowed
- CROSSOVER EXCLUSION: M1774 is primarily metabolized by aldehyde oxidase and to a
lesser extent CYP3A4 and CYP1A2; therefore, concomitant administration with strong
inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir,
indinavir, nelfinavir and saquinavir) and CYP1A2 or inducers of CYP3A4 (e.g.
rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) and CYP1A2 are
prohibited. M1774 is an inhibitor of MATE1 and MATE2K and substrates of these
transporters are also prohibited. These include metformin, acyclovir, estrone
sulfate, ciprofloxacin and cephalexin. Patients who are taking such medications who
cannot discontinue or switch them to an acceptable alternative are not eligible.
Because the lists of these agents are constantly changing, it is important to
regularly consult a frequently-updated medical reference for a list of drugs to
avoid or minimize use of. One example of such a reference is here
(https://go.drugbank.com/categories/DBCAT003956). Patient Drug Information Handout
and Wallet Card) should be provided to patients. As part of the enrollment/informed
consent procedures, the patient will be counseled on the risk of interactions with
other agents, and what to do if new medications need to be prescribed or if the
patient is considering a new over-the-counter medicine or herbal product
- CROSSOVER EXCLUSION: Patients who are on chronic corticosteroid treatment exceeding
10 mg prednisone daily (or equivalent) are excluded. Chronic corticosteroid use
lower than this range is permitted
- CROSSOVER EXCLUSION: Patients with a QTcF (using the Fridericia correction
calculation) of > 470 msec
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:
Ling Gao
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:
Gino K. In
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:
Gino K. In
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:
Gino K. In
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:
Gino K. In
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:
Ling Gao
Email:
Principal Investigator
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
203-785-5702
Email:
canceranswers@yale.edu
Investigator:
Last name:
Jeffrey J. Ishizuka
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Aventura
Address:
City:
Aventura
Zip:
33180
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
954-461-2180
Investigator:
Last name:
Jose Lutzky
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Coral Gables
Address:
City:
Coral Gables
Zip:
33146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jose Lutzky
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Address:
City:
Deerfield Beach
Zip:
33442
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jose Lutzky
Email:
Principal Investigator
Facility:
Name:
University of Miami Miller School of Medicine-Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jose Lutzky
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Kendall
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jose Lutzky
Email:
Principal Investigator
Facility:
Name:
UM Sylvester Comprehensive Cancer Center at Plantation
Address:
City:
Plantation
Zip:
33324
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
305-243-2647
Investigator:
Last name:
Jose Lutzky
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center - McKinley Campus
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-679-0775
Email:
ClinicalTrials@moffitt.org
Investigator:
Last name:
Andrew S. Brohl
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-679-0775
Email:
ClinicalTrials@moffitt.org
Investigator:
Last name:
Andrew S. Brohl
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
404-778-1868
Investigator:
Last name:
Melinda L. Yushak
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:
Sunandana Chandra
Email:
Principal Investigator
Facility:
Name:
Memorial Hospital East
Address:
City:
Shiloh
Zip:
62269
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-747-9912
Email:
dschwab@wustl.edu
Investigator:
Last name:
George Ansstas
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University/Sidney Kimmel Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
410-955-8804
Email:
jhcccro@jhmi.edu
Investigator:
Last name:
Evan J. Lipson
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:
Ann W. Silk
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at West County Hospital
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
George Ansstas
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:
George Ansstas
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:
George Ansstas
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Christian Hospital
Address:
City:
Saint Louis
Zip:
63136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
George Ansstas
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Saint Peters Hospital
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
George Ansstas
Email:
Principal Investigator
Facility:
Name:
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
CancerTrials@nyulangone.org
Investigator:
Last name:
Maya Dimitrova
Email:
Principal Investigator
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
336-713-6771
Investigator:
Last name:
Pierre L. Triozzi
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:
University of Pittsburgh Cancer Institute (UPCI)
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-647-8073
Investigator:
Last name:
Melissa A. Burgess
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Daniel Y. Wang
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-424-2100
Email:
cancerinfo@hci.utah.edu
Investigator:
Last name:
Siwen Hu-Lieskovan
Email:
Principal Investigator
Facility:
Name:
University of Virginia Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
434-243-6303
Email:
uvacancertrials@hscmail.mcc.virginia.edu
Investigator:
Last name:
Varinder Kaur
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:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-804-8824
Investigator:
Last name:
Paul Nghiem
Email:
Principal Investigator
Facility:
Name:
University Health Network-Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
416-946-4501
Email:
clinical.trials@uhn.on.ca
Investigator:
Last name:
Samuel Saibil
Email:
Principal Investigator
Start date:
May 21, 2024
Completion date:
January 1, 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/NCT05947500
