Trial Title:
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
NCT ID:
NCT05733351
Condition:
Castration-Sensitive Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Docetaxel
Antibodies
Immunoglobulins
Antibodies, Bispecific
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Suspended
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone
Description:
Given PO
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
CB 7598
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and stool sample collection
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Given IV
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
Docecad
Other name:
RP56976
Other name:
Taxotere
Other name:
Taxotere Injection Concentrate
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
Given PO
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Other name:
ASP9785
Other name:
MDV3100
Other name:
Xtandi
Intervention type:
Procedure
Intervention name:
FDG-Positron Emission Tomography
Description:
Undergo FDG PET
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
FDG
Other name:
FDG-PET
Other name:
FDG-PET Imaging
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
Magnetic Resonance
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:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
PSMA PET Scan
Description:
Undergo PSMA PET
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
Prostate-specific Membrane Antigen PET
Other name:
PSMA PET
Intervention type:
Drug
Intervention name:
Vudalimab
Description:
Given IV
Arm group label:
Cohort A (Vudalimab, Abiraterone)
Arm group label:
Cohort B (Vudalimab, Enzalutamide)
Arm group label:
Cohort C (Vudalimab, Docetaxel, Abiraterone)
Other name:
Anti-PD-1/Anti-CTLA-4 XmAb20717
Other name:
Anti-PD1/CTLA4 Bispecific Antibody XmAb20717
Other name:
PD-1 x CTLA-4 Bispecific Antibody XmAb20717
Other name:
PD-1 x CTLA-4 Dual Checkpoint Inhibitor XmAb20717
Other name:
XmAb 20717
Other name:
XmAb20717
Summary:
This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in
combination with standard of care treatment abiraterone, enzalutamide, or abiraterone
plus docetaxel in treating patients with castration sensitive prostate cancer that has
spread to other places in the body (metastatic). Immunotherapy with monoclonal
antibodies, such as vudalimab, may help the body's immune system attack the cancer, and
may interfere with the ability of tumor cells to grow and spread. Adding vudalimab to
standard of care treatments may be effective in treating metastatic castration sensitive
prostate cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine the safety and tolerability of vudalimab (XmAb20717) in combination with
standard of care treatment in subjects with metastatic castration sensitive prostate
cancer (mCSPC) as assessed by frequency and intensity of adverse events.
SECONDARY OBJECTIVE:
I. To assess the preliminary antitumor activity of vudalimab (XmAb20717) with standard of
care treatment.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To identify factors that may be indicative of response to vudalimab (XmAb20717) in
combination with standard of care treatments.
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT A: Patients receive vudalimab intravenously (IV) on days 1 and 15 plus abiraterone
orally (PO) once daily (QD) of 4-week cycles on study. Patients also undergo
prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and
fludeoxyglucose (FDG) PET scans during screening. Patients also undergo computed
tomography (CT) and/or magnetic resonance imaging (MRI) scans, bone scans, and blood
sample collection throughout the study.
COHORT B: Patients receive vudalimab IV on days 1 and 15 plus enzalutamide PO QD of
4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during
screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample
collection throughout the study.
COHORT C: Patients receive vudalimab IV on days 1 and 15, docetaxel IV on days 1 and 22
plus abiraterone PO QD of 6-week cycles on study. Patients also undergo PSMA PET and FDG
PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and
blood sample collection throughout the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >= 18 years
- Histologically confirmed adenocarcinoma of the prostate with metastatic disease
- Castration-sensitive status: either not have been treated with androgen deprivation
therapy (ADT) (hormone therapy) or not on ADT at the time of progression
- Participants can have received up to 3 months of ADT with luteinizing
hormone-releasing hormone (LHRH) agonists or antagonists or orchiectomy with or
without concurrent first-generation antiandrogens prior to enrollment, with no
radiographic evidence of disease progression or rising prostate-specific
antigen (PSA) prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Life expectancy > 12 weeks as determined by the investigator
- Hemoglobin >= 9.0 g/dl (within 28 days of cycle 1 day 1) (no transfusions allowed
within 7 days of Cycle 1 Day 1 to meet entry criteria)
- White blood cell (WBC) >= 2000/uL (within 28 days of cycle 1 day 1) (after at least
7 days without growth factor support or transfusion)
- Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days of cycle 1 day 1)
(after at least 7 days without growth factor support or transfusion)
- Platelets >= 100,000/mcL (within 28 days of cycle 1 day 1) (no transfusions allowed
within 7 days of cycle 1 day 1 to meet entry criteria)
- Prothrombin time (PT)/ partial thromboplastin time (PTT) =< 1.5 x upper limit of
normal (ULN) (within 28 days of cycle 1 day 1)
- Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 28 days of
cycle 1 day 1)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 3 institutional
upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28
days of cycle 1 day 1)
- Willingness to provide pre- and post-treatment fresh tumor biopsies, if safe and
medically feasible
- Male subjects must be surgically sterile or must agree to use adequate method of
contraception from the time of consent until at least 120 days after the last dose
of Xmab27017
- Willingness and ability of the subject to comply with scheduled visits, drug
administration plan, protocol specified laboratory tests, other study procedures,
and study restrictions
- Completion of all previous surgery, radiotherapy, chemotherapy, immunotherapy, or
investigational therapy for the treatment of cancer >= 2 weeks before the start of
study therapy. (No radiotherapy to Xmab27017 injection site within 4 weeks)
- Evidence of a personally signed informed consent indicating that the subject is
aware of the neoplastic nature of the disease and has been informed of the
procedures to be followed, the experimental nature of the therapy, alternatives,
potential risks and discomforts, potential benefits, and other pertinent aspects of
study participation
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
the study or those who have not recovered from adverse events due to agents
administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1)
- Patients who are receiving any other investigational agents or an investigational
device within 21 days before administration of first dose of study drugs
- Prior treatment with any CTLA4, PD1, or PDL1, or directed immunotherapy
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to (investigational new drug [IND] agent[s]) or other agents
used in study
- Have known active central nervous system metastases and/or carcinomatous meningitis.
Subjects with previously treated brain metastases may participate provided they are
radiologically stable, ie, are without evidence of progression for at least 4 weeks
by repeat imaging (note that the repeat imaging should be performed during study
screening), are clinically stable, and are without requirement of steroid treatment
for at least 14 days prior to first dose of study treatment
- Active known or suspected autoimmune disease (except that subjects are permitted to
enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism
due to an autoimmune condition that is treatable with hormone replacement therapy
only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is
managed without systemic therapy; or arthritis that is managed without systemic
therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
- Has any condition requiring systemic treatment with corticosteroids, prednisone
equivalents, or other immunosuppressive medications within 14 days prior to first
dose of study drug (except that inhaled or topical corticosteroids or brief courses
of corticosteroids given for prophylaxis of contrast dye allergic response are
permitted.)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements
- Receipt of an organ allograft
- Known history of left ventricular ejection fraction =< 40%
- Receipt of a live-virus vaccine within 30 days prior to first dose of study drug
(seasonal flu vaccines that do not contain live virus are permitted. COVID-19
vaccines are permitted)
- Known human immunodeficiency virus (HIV) positive subject with CD4+ T-cell (CD4+)
counts < 350 cells/uL, or an HIV viral load greater than 400 copies/mL, or a history
of an AIDS (acquired immunodeficiency syndrome)-defining opportunistic infection
within the past 12 months, or who has not been on established antiretroviral therapy
(ART) for at least 4 weeks prior to initiation of study drug dosing. (Effective ART
is defined as a drug, dosage, and schedule associated with reduction and control of
the viral load.)
- Known positive test for hepatitis C ribonucleic acid (RNA) (a subject who is
hepatitis C virus [HCV] antibody positive but HCV RNA negative due to documented,
curative prior antiviral treatment or natural resolution is eligible).
- Known positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core
antibody (HBcAb; a subject whose HBsAg is negative and HBcAb is positive may be
enrolled if a hepatitis B virus [HBV] deoxyribonucleic acid (DNA) test is negative,
and the subject is retested for HBsAg and HBV DNA every 2 months)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Start date:
August 3, 2023
Completion date:
December 16, 2027
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Xencor, Inc.
Agency class:
Industry
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733351
