What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly immunotherapies like those being studied in the REGN4336 trial, include drugs such as sipuleucel-T and PD-1 inhibitors like cemiplimab. The most frequently reported side effects of these treatments are chills, fatigue, fever, back pain, nausea, joint ache, and headache. These side effects are typically mild and transient, resolving within one to two days. Serious adverse events, though rare, can include infusion reactions, cerebrovascular events, and immune-related conditions such as myasthenia gravis and rhabdomyolysis.

What prior FDA approvals exist?

FDA-approved immunotherapies for prostate cancer include sipuleucel-T (Provenge), which is a dendritic cell vaccine designed to stimulate T-cells to attack prostate cancer cells. Additionally, pembrolizumab (Keytruda), a PD-1 inhibitor, is approved for metastatic castration-resistant prostate cancer (mCRPC) with specific genetic markers such as dMMR or high TMB. These treatments are similar to the investigational drug REGN4336, which also aims to activate the immune system to target cancer cells.

What other types of research exist?

Promising novel alternatives to REGN4336 for prostate cancer patients include: 1) P-PSMA-101 CAR-T cells, which are being studied in a phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC). 2) Bipolar Androgen Therapy (BAT), which has shown potential in restoring sensitivity to androgen receptor-targeting therapies in CRPC patients. 3) Anti-PD-1 therapy, such as nivolumab, which has shown efficacy in various cancers and is being explored for prostate cancer. These alternatives represent cutting-edge approaches in immunotherapy and targeted treatments for prostate cancer.

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Monoclonal Antibodies

REGN4336 + Cemiplimab for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma

Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)

Must not have

Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments

Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug called REGN4336, alone or with other drugs, to see if it is safe and effective. It aims to help the immune system attack cancer cells. The study focuses on finding the right dose and understanding side effects.

Who is the study for?

Adults with advanced prostate cancer that's resistant to castration and has worsened despite treatment, including at least one second-generation anti-androgen therapy. Participants must have a PSA level of ≥4 ng/mL and cannot be on high-dose steroids or have had certain recent treatments like systemic biologics, PSMA-targeting therapies, or suffer from significant autoimmune diseases.

What is being tested?

The trial is testing REGN4336 alone and combined with Cemiplimab to evaluate safety, tolerability, dosage levels (Dose Escalation), and preliminary effectiveness in reducing tumor size (Dose Expansion) based on objective response rate criteria. It also examines the drugs' pharmacokinetics—their movement through the body.

What are the potential side effects?

While specific side effects are not listed here, typical ones for cancer immunotherapy may include fatigue, skin reactions, inflammation in organs such as lungs or intestines (colitis), hormonal gland problems (like thyroid issues), infusion-related reactions, liver inflammation (hepatitis), and potential worsening of pre-existing autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is confirmed but not as a pure small cell type.

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My cancer has worsened after 2 or more treatments, including a modern anti-androgen therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease treated with immune-weakening drugs in the last 5 years.

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I haven't taken high doses of steroids or similar medicines in the last week.

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I haven't taken any immune therapy (except Sipuleucel-T) recently.

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I do not have an uncontrolled HIV, hepatitis B or C, or an immunodeficiency.

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I've had cancer treatment within the last 3 weeks or am still recovering from side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence and severity of Immune-mediated Adverse Events (imAEs)

Incidence and severity of Serious Adverse Events (SAEs)

Incidence and severity of adverse event of special interest (AESIs)

+3 more

Secondary study objectives

ADA to REGN4336 and REGN5678

ADA to REGN4336 and cemiplimab

Anti-drug antibodies (ADA) to REGN4336

+11 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Infusion related reaction

13%

Vomiting

13%

Nausea

13%

Constipation

13%

Diarrhoea

13%

Subcutaneous abscess

13%

Hyperthyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Module 3-Combo TherapyExperimental Treatment3 Interventions

REGN4336 + REGN5678

Group II: Module 2-Combo TherapyExperimental Treatment3 Interventions

REGN4336 + Cemiplimab

Group III: Module 1- MonotherapyExperimental Treatment2 Interventions

REGN4336

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sarilumab

2020

Completed Phase 3

~5980

Cemiplimab

2015

Completed Phase 3

~1470

0 / 7Eligibility criteria met

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

Prostate cancer treatments often include immunotherapy, which aims to harness the body's immune system to fight cancer. Treatments like REGN4336, cemiplimab, and REGN5678 work by activating T-cells to target and destroy cancer cells. This is crucial for prostate cancer patients as it offers a targeted approach that can potentially reduce tumor size and slow disease progression. Immunotherapy can be particularly beneficial for patients with advanced or castration-resistant prostate cancer, providing an alternative when traditional therapies are ineffective.