What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including monoclonal antibodies like Enoblituzumab and immune checkpoint inhibitors, often have side effects such as fatigue, anorexia, nausea, and immune-related adverse events like colitis and hypothyroidism. Androgen deprivation therapy (ADT) can lead to hot flashes, decreased libido, and osteoporosis. Second-generation androgen receptor inhibitors like enzalutamide may cause fatigue, seizures, and increased risk of falls. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including monoclonal antibodies and other immunotherapies. Pembrolizumab, an anti-PD-1 monoclonal antibody, has shown efficacy in various cancers and is being studied in combination with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC) in the KEYNOTE-641 trial. Other notable treatments include sipuleucel-T, a cancer vaccine that stimulates the immune system to attack prostate cancer cells, and radium-223, a radiopharmaceutical that targets bone metastases. These treatments aim to inhibit tumor growth and enhance the immune response, similar to the investigational drug Enoblituzumab.

What other types of research exist?

Promising alternatives to Enoblituzumab for prostate cancer treatment in 2024 include: 1) Pembrolizumab (a PD-1 inhibitor) which has shown efficacy in various cancers including prostate cancer, 2) Avelumab (a PD-L1 inhibitor) which has demonstrated durable responses in clinical trials, and 3) Ipilimumab (a CTLA-4 inhibitor) which, when combined with other therapies like nivolumab, has shown effectiveness in treating advanced cancers. These therapies target different immune checkpoints and have been evaluated in clinical trials for their anti-tumor effects and safety profiles.

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Enoblituzumab for Prostate Cancer

Phase 2

Waitlist Available

Led By Emmanuel Antonarakis, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-prostatectomy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Enoblituzumab, a drug that boosts the immune system to fight cancer, in men with high-risk prostate cancer. The medication helps the immune system identify and kill cancer cells more effectively.

Who is the study for?

Men over 18 with intermediate/high-risk localized prostate cancer (stage T1c-T3b, N0, M0) can join. They must have a scheduled radical prostatectomy at Johns Hopkins Hospital, good physical health and organ function, and agree to use barrier contraception from the first dose until surgery. Excluded are those who've had prior treatments for prostate cancer or other cancers in the last 3 years (except certain skin/bladder cancers), autoimmune diseases needing immunosuppression, major illnesses, or known HIV/hepatitis B/C.

What is being tested?

The trial is testing Enoblituzumab's safety and effectiveness when given before surgical removal of the prostate. Participants will receive six weekly doses starting about seven weeks before their surgery to see if it helps reduce tumor size and affects immune response.

What are the potential side effects?

Possible side effects of Enoblituzumab may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, nausea, changes in blood pressure or heart rate. More serious but less common could be allergic reactions or effects on immune system causing it to attack normal cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-prostatectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-prostatectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-prostatectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate

Number of Participants With Treatment-related Adverse Events

Secondary study objectives

CD4+ T Cell Infiltration

CD8-Positive T-Lymphocytes

Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue

+10 more

Other study objectives

Androgen Receptor (AR) Quantification

B7-H3 Expression

FC Receptor Genotyping

+7 more

Side effects data

From 2022 Phase 1 trial • 3 Patients • NCT04630769

100%

Weight loss

100%

Hypocalcemia

100%

Hypoalbuminemia

100%

Hyperglycemia

100%

Anorexia

100%

Abdominal pain

100%

Pain

100%

Chills

100%

Alanine aminotransferase increased

100%

Alkaline phosphatase increased

100%

Bloating

100%

Lymphocyte count decreased

100%

Neoplasms benign, malignant and

100%

Anemia

100%

Vomiting

100%

Flatulence

100%

Fatigue

100%

Fever

100%

Platelet count decreased

100%

White blood cell decreased

100%

Aspartate aminotransferase increased

100%

Proteinuria

100%

Dyspnea

100%

Pruritus

100%

Constipation

100%

Nausea

100%

Hyponatremia

100%

Myalgia

100%

Headache

100%

Insomnia

100%

Hematoma

100%

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15

Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15

Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EnoblituzumabExperimental Treatment1 Intervention

Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enoblituzumab

Not yet FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), androgen receptor inhibitors, and immune checkpoint inhibitors. ADT reduces androgen levels, which prostate cancer cells rely on for growth. Androgen receptor inhibitors, such as enzalutamide and abiraterone, block the androgen receptor signaling pathway, further inhibiting tumor growth. Immune checkpoint inhibitors, like pembrolizumab, enhance the immune system's ability to recognize and attack cancer cells. Enoblituzumab, a monoclonal antibody targeting B7-H3, works by inhibiting tumor growth and enhancing the immune response. These treatments are vital as they target specific mechanisms that allow prostate cancer to grow and evade the immune system, offering multiple avenues to control the disease.