Who is eligible for clinical trial NCT06347705?

Participants must meet protocol criteria for Prostate Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06347705 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-13

A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer (NCT06347705)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (32 items).

Location: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Male aged 18 years and above
Serum testosterone of ≥150 ng/dL except for patients currently on ADT.
Adequate bone marrow, hepatic, and renal function, as evidenced within 28 days prior to treatment start by: ANC ≥1500/µl (≥1000/µl if benign ethnic neutropenia) Hemoglobin ≥9 g/dL Platelet count ≥100,000/µl Creatinine Clearance Measure by Cockcroft-Gault Formula \>45 mL/min Total Bilirubin ≤ 1.8 mg/dl (Note: In participants with Gilbert's syndrome, if total bilirubin is 1.8 mg/dL, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible) SGOT (AST) ≤ 92.5 U/L SGPT (ALT) ≤ 137 U/L
Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 8th edition American Joint Committee on Cancer (AJCC) staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectal ultrasound, CT scan, and/or MRI.
Candidate for RP with lymph node dissection as per the investigator
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
Evidence of a prostate lesion on prostate magnetic resonance imaging scan

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Participants that meet any of the criteria listed below will not be eligible for study entry:
Prior prostate surgery, pelvic lymph node dissection, radiation therapy, or focal therapy as a treatment for prostate cancer or benign prostatic disease.
Current ADT with GnRH antagonist/agonist and/or ARSI initiated \>12 weeks enrollment.
Prior cytotoxic chemotherapy for prostate cancer
Prior experimental therapy for prostate cancer within 30 days of planned Cycle 1 of 2141-V11.
Known brain, liver, lung or other visceral metastasis (with the exception of retroperitoneal and / or pelvic nodal metastases as per inclusion criteria)
Prior prostate cancer metastasis-directed therapies other than described above.
Currently active second malignancy or past medical history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of \< 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer.
Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:
Any medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone once daily
Active infection requiring systemic therapy
History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York
Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗