RecruitingPhase 1 / Phase 2

A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy

A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of REGN5678 before surgery to remove the prostate. It is for adult men with high-risk prostate cancer that has not spread to distant parts of the body and can be removed with surgery.

To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older.
  • A biopsy must show prostate adenocarcinoma, a type of prostate cancer, with a Gleason score of 8 or higher. This score means the cancer is more likely to grow and spread. It must be found in at least 3 samples, with at least 8 mm in one sample. MD Anderson must review the biopsy.
  • Able to do daily tasks, with no limits or only limits on hard physical activity.
  • Scans must show no cancer spread to distant parts of the body. A surgeon must find you fit for surgery to remove the prostate and nearby pelvic lymph nodes.
  • No past prostate cancer treatment, except TURP, a procedure that removes prostate tissue through the urine tube.
  • Blood tests must meet the study's limits for blood cell counts and kidney and liver health.
  • Sign consent forms, agree to the MD Anderson lab protocol, and be willing and able to attend visits and complete study procedures.
  • Use condoms during sex while taking the drug and for 3 months after the last dose, even after a vasectomy. Use another effective birth control method too if your partner could become pregnant. Do not donate sperm during this time.

Who can't join

  • Certain other prostate cancer types or mixed types; past hormone treatment for prostate cancer, except drugs called 5-alpha reductase inhibitors; or taking part in another study that tests a treatment.
  • Use of medicines that weaken the immune system within 14 days before treatment, including more than 10 mg of prednisone daily or an equal dose of another steroid. Skin, inhaled, nasal, and eye steroids are allowed.
  • An autoimmune disease, where the immune system attacks the body, with some exceptions; or an active infection needing treatment throughout the body. Well-controlled HIV is allowed if the virus cannot be detected and the CD4 immune cell count is above 350.
  • Serious heart or blood vessel disease, including a heart attack, unstable chest pain, major blood clot, or stroke within 6 months. Certain implants also rule you out, including artificial heart valves, artificial joints placed within 12 months, or implants that cannot be removed and have caused infection or other serious problems.
  • Another cancer within 2 years, with exceptions for certain treated skin cancers, surface bladder cancer, or cancers that have not grown beyond their starting layer and are in complete remission. Major surgery within 14 days before the first dose also rules you out.
  • Certain brain or nervous system diseases, or uncontrolled seizures, in the past year. Mild dementia that does not affect daily tasks is allowed. Certain lung scarring or lung inflammation not caused by infection within the past 5 years also rules you out.
  • A live vaccine within 4 weeks before treatment; any organ transplant or stem cell transplant from a donor; or a transplant using your own stem cells within 12 weeks before treatment.
  • Any medical, mental health, or social issue that the study doctor believes would prevent participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Men ≥ 18 years of age * Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible * Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1 * No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment * Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection * No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate \[TURP\]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy * Hemoglobin ≥ 11 g/dL * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \> 50 mL/min/1.73 m\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria * Total bilirubin ≤ 1.5 x ULN * NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN * Alkaline phosphatase (ALP) ≤ 2.5 x ULN * Consent to MD Anderson laboratory protocol PA13-0291 * Willing and able to comply with clinic visits and study-related procedures * Provide informed consent signed by study patient * To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug Exclusion Criteria: * Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists * Currently enrolled in another interventional study * Concurrent treatment with systemic corticosteroids (prednisone dose \> 10 mg per day or equivalent) or other immunosuppressive drugs \< 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted * History of or known or suspected autoimmune disease (exception\[s\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed) * Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \[RNA\] polymerase chain reaction \[PCR\]) and CD4 counts greater than 350 are permitted to participate * History of clinically significant cardiovascular disease including, but not limited to: * Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation * Clinically significant cardiac arrhythmia * Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation * Congestive heart failure (New York Heart Association class III-IV) * Pericarditis/clinically significant pericardial effusion * Myocarditis * Endocarditis * History of major implant(s) or device(s), including but not limited to: * Prosthetic heart valve(s) * Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation * Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed * Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment * Has received major surgery within 14 days of first administration of study drug * Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy * Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years) * Receipt of a live vaccine within 4 weeks of planned start of study medication * Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment * Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study

Study sites (1)

TX