Actively Recruiting
A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16
57
Participants Needed
7
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment.
CONDITIONS
Official Title
A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years and above
- Willing and able to provide written informed consent and HIPAA authorization
- Serum testosterone of 5150 ng/dL except for patients currently on androgen deprivation therapy
- Adequate bone marrow, liver, and kidney function as shown by specified blood test results within 28 days prior to treatment
- Clinical T stage of prostate cancer documented within 90 days before treatment using AJCC staging
- Candidate for radical prostatectomy with lymph node dissection
- Agree to use condom and another effective birth control method if sexually active with a woman of childbearing potential, or condom if with a pregnant woman, during and for 3 months after study drug
- Agree not to donate sperm during study and for 3 months after last dose
- Evidence of prostate lesion on prostate MRI scan
You will not qualify if you...
- Prior prostate surgery, pelvic lymph node dissection, radiation therapy, or focal therapy for prostate cancer or benign prostate disease
- Current androgen deprivation therapy with GnRH antagonist/agonist or ARSI started more than 12 weeks before enrollment
- Prior chemotherapy for prostate cancer
- Prior experimental therapy for prostate cancer within 30 days before starting 2141-V11
- Known brain, liver, lung, or other visceral metastasis except retroperitoneal or pelvic nodal metastases
- Prior metastasis-directed therapies for prostate cancer other than allowed
- Active second malignancy or certain past cancers diagnosed within last 5 years requiring therapy or with life expectancy under 5 years, except some treated skin and early cancers
- Significant medical conditions that may prevent consistent study participation or increase risk, including uncontrolled hypertension, active infections, gastrointestinal disorders affecting drug absorption, moderate to severe liver impairment, HIV with specified conditions, pituitary or adrenal dysfunction, significant heart disease, seizure history, inflammatory bowel disease, or other medications interfering with immunotherapy
- Use of prohibited medications within 14 days before treatment
- Known allergies or intolerance to study drugs
- Inability to tolerate MRI
- Clinically significant symptoms related to local or metastatic disease for cohort B participants
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
M
Matthew Dallos, MD
CONTACT
K
Karen Autio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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