Trial Title:
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
NCT ID:
NCT05896839
Condition:
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Metastatic Basal Cell Carcinoma
Metastatic Carcinoma in the Skin
Metastatic Melanoma
Metastatic Merkel Cell Carcinoma
Metastatic Skin Squamous Cell Carcinoma
Unresectable Basal Cell Carcinoma
Unresectable Melanoma
Unresectable Merkel Cell Carcinoma
Unresectable Skin Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Melanoma, Cutaneous Malignant
Skin Neoplasms
Sirolimus
Prednisone
Cortisone
Nivolumab
Ipilimumab
Temsirolimus
MTOR Inhibitors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo tumor biopsy
Arm group label:
Treatment (nivolumab and ipilimumab)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (nivolumab and ipilimumab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (nivolumab and ipilimumab)
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:
Treatment (nivolumab and ipilimumab)
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:
Kidney Biopsy
Description:
Undergo kidney biopsy
Arm group label:
Treatment (nivolumab and ipilimumab)
Other name:
Biopsy of Kidney
Other name:
Renal Biopsy
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (nivolumab and ipilimumab)
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:
Treatment (nivolumab and ipilimumab)
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:
Drug
Intervention name:
Prednisone
Description:
Given PO
Arm group label:
Treatment (nivolumab and ipilimumab)
Other name:
.delta.1-Cortisone
Other name:
1, 2-Dehydrocortisone
Other name:
Adasone
Other name:
Cortancyl
Other name:
Dacortin
Other name:
DeCortin
Other name:
Decortisyl
Other name:
Decorton
Other name:
Delta 1-Cortisone
Other name:
Delta-Dome
Other name:
Deltacortene
Other name:
Deltacortisone
Other name:
Deltadehydrocortisone
Other name:
Deltasone
Other name:
Deltison
Other name:
Deltra
Other name:
Econosone
Other name:
Lisacort
Other name:
Meprosona-F
Other name:
Metacortandracin
Other name:
Meticorten
Other name:
Ofisolona
Other name:
Orasone
Other name:
Panafcort
Other name:
Panasol-S
Other name:
Paracort
Other name:
Perrigo Prednisone
Other name:
PRED
Other name:
Predicor
Other name:
Predicorten
Other name:
Prednicen-M
Other name:
Prednicort
Other name:
Prednidib
Other name:
Prednilonga
Other name:
Predniment
Other name:
Prednisone Intensol
Other name:
Prednisonum
Other name:
Prednitone
Other name:
Promifen
Other name:
Rayos
Other name:
Servisone
Other name:
SK-Prednisone
Intervention type:
Drug
Intervention name:
Sirolimus
Description:
Given PO
Arm group label:
Treatment (nivolumab and ipilimumab)
Other name:
AY 22989
Other name:
AY-22989
Other name:
AY22989
Other name:
RAPA
Other name:
Rapamune
Other name:
Rapamycin
Other name:
SILA 9268A
Other name:
SILA-9268A
Other name:
SILA9268A
Other name:
WY 090217
Other name:
WY-090217
Other name:
WY090217
Summary:
This phase II trial tests the combination of nivolumab and ipilimumab with sirolimus and
prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery
(unresectable) or that has spread from where it first started to other places in the body
(metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and
ipilimumab, may induce changes in body's immune system and may interfere with the ability
of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that
are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and
ipilimumab in combination with sirolimus and prednisone may kill more cancer cells, while
also keeping the transplanted kidney healthy, in patients with unresectable or metastatic
cutaneous cancer who have received a kidney transplant.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the proportion of kidney transplant recipients with selected advanced
cutaneous cancers who at 14 weeks after administration of prednisone, sirolimus,
nivolumab, and ipilimumab experience complete response (CR), partial response (PR), or
stable disease (SD) without allograft loss.
SECONDARY OBJECTIVE:
I. To estimate the objective response rate (ORR), rate of allograft loss, and durations
of progression-free survival (PFS) and overall survival (OS) in the study population.
EXPLORATORY OBJECTIVES:
I. To characterize correlates of the host immune response including, but not limited to:
Ia. Histopathological characteristics of allograft rejection/loss; Ib. Immunological
changes in the tumor microenvironment (e.g., changes in T-cell subset populations or
expression of immune checkpoint molecules) in paired biopsies obtained pre-treatment and
on-treatment; Ic. Characteristics of anti-programmed death-1 (PD-1)-associated
immune-mediated adverse reactions (IMARs) in this patient population treated with
immunosuppression; Id. To identify upregulated immune-related genes using multiplex
quantitative reverse transcription polymerase chain reaction (qRT-PCR).
II. To observe whether changes in donor-derived cell-free deoxyribonucleic acid (DNA)
(dd-cfDNA) as a marker for allograft rejection.
III. To compare baseline patient allograft/donor characteristics, to include human
leukocyte antigen (HLA) status, date of transplant, presence of donor specific
antibodies, history of prior rejection, and Calculated Panel Reactive Antibodies score,
in patients who experience and do not experience rejection while on this study.
IV. To observe the objective response rate (ORR) of patients who achieve PR/CR or stable
disease for >= 6 months with eventual progressive disease requiring re-induction with
nivolumab + ipilimumab (receive > 4 doses of nivolumab + ipilimumab).
OUTLINE:
Patients receive sirolimus orally (PO) and prednisone PO daily, starting 7 days prior to
cycle 1 day 1 of immunotherapy. Patients also receive nivolumab intravenously (IV) over
30 minutes and ipilimumab IV over 30 minutes on day 8 of cycle 1 and day 1 of cycle 2.
Six weeks after the first dose of nivolumab and ipilimumab, patients undergo tumor
response assessment. Patients who achieve stable disease (SD), partial response (PR), or
complete response (CR) receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4
weeks for a total of 24 cycles in the absence of disease progression or unacceptable
toxicity. Patients who had disease progression at this time or any time on trial may
receive nivolumab IV and ipilimumab IV on day 1 of each cycle. Cycles repeat every 3
weeks for 2 cycles, in the absence of unacceptable toxicity. Patients are then assessed
for tumor response again after 6 weeks and receive nivolumab monotherapy if they achieve
SD, PR, or CR. If patients have progressive disease, they may receive nivolumab
monotherapy or discontinue study treatment.
Patients may undergo magnetic resonance imaging (MRI) during screening, undergo tumor
biopsy on study and undergo computed tomography (CT) scan and blood sample collection
throughout the study. Patients may undergo kidney biopsy if rejection is suspected.
Patients follow up every 12 weeks for 1 year after stopping therapy, then every 16 weeks
for the second year after stopping and then every 20 weeks for up to 5 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must be kidney transplant recipients with a functioning allograft who do
not currently require dialysis
- Patient's age must be >= 18 years. Because no dosing or adverse event (AE) data are
currently available on the use of nivolumab and ipilimumab in kidney transplant
recipients <18 years of age, children are excluded from this study, but may be
eligible for future pediatric trials
- Patients must have histologically or cytologically confirmed non-uveal melanoma,
basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma
for which standard non-immunological medical, surgical, or radiation therapy would
be insufficient (i.e., patients who are not surgical candidates). Patients with
cutaneous squamous cell carcinoma or Merkel cell carcinoma may enroll without prior
medical therapy (e.g., cetuximab or chemotherapy respectively). Non-immunologic
standard therapies that patients must have received, refused or for which patients
were ineligible include:
- For patients with BRAF-mutant melanoma, prior therapies include BRAF/MEK
inhibitors
- For patients with Basal cell carcinoma, prior therapies include hedgehog
pathway inhibitors
- Patients must have measurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 criteria, i.e., at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded for non-nodal
lesions and short axis for nodal lesions) as >= 20 mm by chest x-ray or as >= 10 mm
with CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam is
preferred, but not required
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2
(Karnofsky >= 60%) performance status criteria
- Leukocytes >= 2,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 50,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT])
=< 2.5 x institutional ULN
- Serum creatinine =< 3 x ULN
- dd-cfDNA =< 1.0% and =< 61% increase
- The effects of nivolumab and ipilimumab on the developing human fetus are unknown.
For this reason, and because other therapeutic agents used in this trial are known
to be teratogenic, women of childbearing potential (WOCBP) receiving nivolumab must
continue contraception for a period of 5 months after the last dose of nivolumab.
Women who are not of childbearing potential (i.e., who are postmenopausal or
surgically sterile) as well as azoospermic men do not require contraception.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or
equivalent units of beta-human chorionic gonadotropin [B-HCG]) during the screening
period. Follow-up evaluations will include interval sexual/menstrual histories as needed.
Should a woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she (or the participating partner) should inform the
treating physician immediately.
WOCBP is defined as any female who has experienced menarche and who has not undergone
surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not
postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman
over 45 in the absence of other biological or physiological causes. Women under the age
of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40
mIU/mL to be considered postmenopausal.
- Human immunodeficiency virus (HIV)-infected patients will be eligible for this trial
if they are on effective antiretroviral regimens utilizing non-CYP-interactive
agents and have an undetectable viral load. If there is evidence of chronic
hepatitis B virus (HBV) infection, HBV viral load must be undetectable on
suppressive therapy, if indicated. If there is history of hepatitis C virus (HCV)
infection, the patient must have been treated and have undetectable HCV viral load.
- 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
Exclusion Criteria:
- Patients who have received a liver, lung, heart, or pancreas transplant; or
allogeneic stem cell transplant; or any kind of bone marrow transplant
- Patients unwilling or unable to undergo dialysis in the event of allograft failure
- Patients with prior evidence of human leukocyte antigen (HLA) or non-HLA
donor-specific antibodies (DSA)
- Patients with a history of antibody- or cell-mediated allograft rejection within 3
months of study entry
- Potential trial participants should have recovered from clinically significant
adverse events of their most recent therapy/intervention prior to enrollment
- Patients must not have had prior treatment for their current cancer with an
anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3 or anti-CTLA-4 antibody, or any other
antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint
pathways within 1 year of study enrollment. Prior history of adjuvant therapy is
allowed if received over 1 year prior to enrollment
- Patients must not be receiving any other investigational agents
- Patients with leptomeningeal metastases, more than 3 untreated central nervous
system (CNS) metastases, untreated brain metastases measuring >1cm, or requiring
treatment-dose steroids (> 10 mg/day prednisone equivalents) for CNS-related
symptoms. Exclusions are due to concerns regarding progressive neurologic
dysfunction that would confound the evaluation of neurologic and other AEs. Patients
with brain metastases meeting the above requirements are permitted to enroll
- Patients must not have a history of severe hypersensitivity reaction to any
monoclonal antibody
- Patients must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to other agents used in the study
- Patients must not have uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or any other significant condition(s) that
would make this protocol unreasonably hazardous
- Pregnant women are excluded from this study because nivolumab and ipilimumab have
the potential for teratogenic or abortifacient effects. Because there is an unknown
but potential risk for AEs in nursing infants secondary to treatment of the mother,
breastfeeding should be discontinued if the mother is treated with nivolumab or
ipilimumab. These potential risks may also apply to other agents used in this study
- Patients with autoimmune disease that is active or might recur and affect vital
organ function will be eligible only after consultation with the study PI.
Guillain-Barre (GB) syndrome, bullous skin disease, Stevens Johnson syndrome, or
toxic epidermal necrolysis will be excluded
- Patients must not have had evidence of active or acute diverticulitis,
intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known
risk factors for bowel perforation should be evaluated for the potential need for
additional treatment before coming on study. In addition, patients with a history of
cardiac disease including coronary artery disease (CAD), myocardial infarction (MI),
cardiomyopathy, arrhythmia, heart block, should have an evaluation by history
pulmonary embolism (PE) and appropriate testing to allow evaluation of any events
that may occur on study. These may include troponin, electrocardiogram (EKG),
echocardiogram (ECHO) as clinically indicated and may include results already in the
medical record if available
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Keck Medicine of USC Koreatown
Address:
City:
Los Angeles
Zip:
90020
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
213-388-0908
Investigator:
Last name:
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:
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:
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:
Michael Lowe
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:
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evan J. Lipson
Phone:
410-502-5977
Email:
evanlipson@jhmi.edu
Investigator:
Last name:
Evan J. Lipson
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:
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:
NYU Langone Hospital - Long Island
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-263-4432
Email:
cancertrials@nyulangone.org
Investigator:
Last name:
Maya Dimitrova
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:
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:
Diwakar Davar
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:
Kathleen C. Kerrigan
Email:
Principal Investigator
Start date:
July 24, 2024
Completion date:
January 31, 2027
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/NCT05896839
