Trial Title:
Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer
NCT ID:
NCT06014255
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
enoblituzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Enoblituzumab
Description:
Enoblituzumab 15mg/kg IV (in the vein) every 2 weeks for 12 weeks prior to radical
prostatectomy on day 84.
Arm group label:
Enoblituzumab
Other name:
MGA271
Intervention type:
Other
Intervention name:
Standard of Care
Description:
Radical prostatectomy within 4-8 weeks of randomization.
Arm group label:
Standard of Care
Summary:
This study evaluates the efficacy, anti-tumor effect, and immunogenicity of neoadjuvant
enoblituzumab given before radical prostatectomy. Patients will be randomized to
enoblituzumab for a total of 12 weeks beginning 84 days before radical prostatectomy or
standard of care arms.
Detailed description:
This is a multi-center, randomized, phase 2 study evaluating the efficacy, anti-tumor
effect, and immunogenicity of neoadjuvant enoblituzumab given prior to radical
prostatectomy in men with high-risk localized prostate cancer. Patients will be recruited
from the outpatient Urology clinics and Multidisciplinary Prostate Cancer ("Precision
Medicine") Clinics at four participating institutions including: Harvard/Dana-Farber
Cancer Centers, Northwestern Lurie Comprehensive Cancer Center, Mayo Clinic, and the
University of Minnesota Masonic Cancer Center. Eligible patients will undergo a
pre-treatment prostate biopsy and conventional imaging (CT and bone scan) as well as
PSMA-PET and optional prostate MRI as per institutional preferences. Patients who have N0
M0 disease by conventional imaging (N1 by PSMA allowed with up to 3 LNs each ≤1 cm) will
be trial eligible as long as concurrent hormonal or radiation therapy is not given.
Patients will then be randomized to enoblituzumab for a total of 12 weeks beginning 84
days prior to radical prostatectomy or SOC arms. Fourteen days after the last treatment,
prostate glands will be harvested at radical prostatectomy, and prostate tissue will be
examined for pathologic response and secondary pharmacodynamic/immunologic endpoints as
described herein. Pre-treatment, on-treatment, and post-treatment biomarkers of response
and resistance will be collected including: plasma, PBMC. Repeat PSMA scan will be
obtained prior to radical prostatectomy. Follow-up evaluation for adverse events will
occur 30 and 90 days after surgery. Patients will then be followed by the patient's
urologists/oncologists according to standard institutional practices but will require PSA
evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
To be eligible for this study, patients must meet all of the following criteria:
- Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0,
M0) without involvement of lymph nodes, bone, or visceral organs by CT or NM bone
scan. N1 by PSMA allowed with up to 3 LNs each ≤1 cm. If there is no frank bone
disease, but PSMA scan and CT scan are in discordance, then investigators will
discuss.
- Initial prostate biopsy, obtained within 3 months of enrollment, is available for
central pathologic review, and is confirmed to show at least 3 positive cores (at
least 1 core with at least 50% disease involvement with ≥4+3=7 disease) and a
Gleason sum of ≥8 (or 4+3=7 with at least 1 additional high-risk feature such as
PSA>20 or cT3)
- Radical prostatectomy has been scheduled
- Age ≥18 years
- ECOG performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)
- Adequate bone marrow, hepatic, and renal function:
- WBC >3,000 cells/mm3
- ANC >1,500 cells/mm3
- Hemoglobin >9.0 g/dL
- Platelet count >100,000 cells/mm3
- Serum creatinine <1.5 × upper limit of normal (ULN)
- Serum bilirubin <1.5 × ULN
- ALT <3 × ULN
- AST <3 × ULN
- Alkaline phosphatase <3 × ULN
- The etiology of abnormal bilirubin and transaminase levels should be evaluated prior
to study entry.
- Willingness to provide written informed consent and HIPAA authorization for the
release of personal health information, and the ability to comply with the study
requirements (note: HIPAA authorization will be included in the informed consent)
- Willingness to use barrier contraception from the time of first dose of
Enoblituzumab (MGA271) until the time of prostatectomy.
Exclusion Criteria:
To be eligible for this study, patients should not meet any of the following criteria:
- Presence of known lymph node involvement on CT (N1 by PSMA allowed with up to 3 LNs
each ≤1 cm) or distant metastases by CT and NM bone scan
- Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma,
small cell, and neuroendocrine tumors
- Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for
prostate cancer
- Prior immunotherapy/vaccine therapy for prostate cancer
- Prior use of experimental agents for prostate cancer
- Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors
- Current use of systemic corticosteroids or use of systemic corticosteroids within 4
weeks of enrollment (inhaled corticosteroids for asthma or COPD are permitted as are
other non-systemic steroids such as topical corticosteroids)
- History or presence of autoimmune disease requiring systemic immunosuppression
(including but not limited to: inflammatory bowel disease, systemic lupus
erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis,
hemolytic anemia, Sjögren syndrome, and sarcoidosis)
- History of malignancy within the last 3 years, with the exception of non-melanoma
skin cancers and superficial bladder cancer
- Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or
psychiatric illnesses that would make the patient a poor study candidate
- Known prior or current history of HIV and/or hepatitis B/C, with the exception of
patients who have been successfully treated for hepatitis B/C (i.e. documented
confirmation of cure at least 6 months after initial treatment).
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northewestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claire Carter
Phone:
312-694-9001
Email:
claire.carter@northwestern.edu
Contact backup:
Last name:
MD
Investigator:
Last name:
Ashley Ross, MD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eugene Shenderov, MD, PhD
Phone:
410-502-7885
Email:
eugene.shenderov@jhmi.edu
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55414
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Simone Veum
Phone:
612-624-0937
Email:
veum0015@umn.edu
Investigator:
Last name:
Christopher Warlick, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paras Shah, MD
Phone:
507-466-0191
Email:
Shah.Paras@mayo.edu
Contact backup:
Last name:
Urology Study Coordinator
Phone ext:
(507) 422-5102
Email:
Biffert.Hosanna@mayo.edu
Investigator:
Last name:
Paras Shah, MD
Email:
Principal Investigator
Facility:
Name:
XCancer - Omaha, LLC
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Emily Rosso
Phone:
402-991-8468
Email:
emily@xcancer.com
Investigator:
Last name:
Luke Nordquist, MD
Email:
Principal Investigator
Start date:
February 16, 2024
Completion date:
March 1, 2029
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
MacroGenics
Agency class:
Industry
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06014255
