What side effects are associated with this type of intervention?

Common side effects of cancer vaccines like sipuleucel-T include chills, fatigue, fever, back pain, nausea, joint ache, and headache, which are typically mild and transient. Serious adverse events can include infusion reactions and cerebrovascular events. For PD-1 inhibitors such as cemiplimab, side effects often include fatigue, rash, diarrhea, and pruritus, with more severe events like pneumonitis and colitis occurring less frequently. Both treatment types aim to enhance the immune response against cancer cells but can lead to immune-related adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer that are similar to the BNT112 cancer vaccine and cemiplimab include sipuleucel-T (Provenge), which is an autologous cellular immunotherapy designed to stimulate the patient's immune system to target prostate cancer cells. Additionally, pembrolizumab (Keytruda), a PD-1 inhibitor, is approved for use in metastatic castration-resistant prostate cancer (mCRPC) with specific genetic markers such as dMMR or high TMB. These treatments aim to enhance the body's immune response against cancer cells, similar to the investigational therapies BNT112 and cemiplimab.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment in 2024 include: <ol> <li>Lutetium-177-PSMA-617: A radioligand therapy targeting PSMA-positive metastatic CRPC, showing improved survival rates.</li> <li>Pembrolizumab (PD-1 Inhibitor): Demonstrated durable responses in some CRPC patients, particularly those with PD-L1 expression.</li> <li>Ra-223 (Radium-223 dichloride): Used in combination with other therapies like abiraterone or enzalutamide, showing potential for improved survival and reduced fracture risk when combined with osteoclast inhibitors.</li> <li>Docetaxel plus Ra-223: Combined therapy showing durable decreases in serum tumor markers and lower rates of febrile neutropenia compared to docetaxel alone.</li> </ol>

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Cancer Vaccine

Cancer Vaccine + Cemiplimab for Prostate Cancer (PRO-MERIT Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

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

Must have

Patients must have at least 1 of the following: PSA >20 ng/mL, Gleason Score >7, or Localized stage ≥cT2c, N0, M0 according to tumor, node, metastasis classification.

Treatment-naïve patients with LPC according to risk levels of the European Association of Urology Guidelines on Prostate Cancer and U.S. National Comprehensive Cancer Network (NCCN 2020).

Must not have

Patients with any lymphoproliferative disorder.

Patients with active malignancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a vaccine may help treat prostate cancer.

Who is the study for?

This trial is for men aged 18 or older with confirmed prostate cancer. It's specifically for those with high-risk, localized prostate cancer who are planning a radical prostatectomy and have not received certain treatments like systemic corticosteroids or immunomodulating agents recently. Men must be in good physical condition (ECOG PS score of 0 or 1) and agree to provide tumor samples.

What is being tested?

The PRO-MERIT trial is testing the BNT112 cancer vaccine alone or combined with cemiplimab in patients. The study will look at how safe these treatments are, how well they work, and what kind of immune response they create against metastatic castration-resistant and high-risk localized prostate cancers.

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue, as well as more serious immune-related responses due to cemiplimab which could affect organ function.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has a high PSA level, Gleason Score, or is at an advanced localized stage.

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I have untreated low-risk prostate cancer according to major guidelines.

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My prostate cancer has been confirmed through a tissue examination.

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I am a man and I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have undergone castration and my testosterone level is below 1.7 nmol/L.

Exclusion Criteria

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

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I have a disorder that affects my lymph cells.

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I currently have an active cancer.

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I had radiation therapy aimed at curing my cancer within the last 14 days.

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I have not used treatments or products that could lower my PSA levels.

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My side effects from past cancer treatments are mild or gone.

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I have had symptoms from cancer spreading to my brain or its coverings.

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I have a history of HIV, Hepatitis B, or Hepatitis C.

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I haven't had major surgery in the last 4 weeks and don't plan any during the trial.

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I have no other cancers besides the one I am seeking treatment for.

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I have active brain metastases.

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I am on long-term steroids for immune suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (ORR) - Part 2 Arms 1A and 1B

Occurrence of treatment-emergent adverse events (TEAEs)

Secondary study objectives

Change in PSA doubling time (PSADT)

Change in prostate-specific antigen (PSA) levels

ORR - Part 1

+1 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Diarrhoea

13%

Subcutaneous abscess

13%

Hyperthyroidism

13%

Nausea

13%

Constipation

13%

Infusion related reaction

13%

Vomiting

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

6Treatment groups

Experimental Treatment

Group I: Part 2 Arm 3 (LPC) - expansion cohortExperimental Treatment1 Intervention

BNT112 monotherapy

Group II: Part 2 Arm 2 (LPC) - expansion cohortExperimental Treatment2 Interventions

BNT112 in combination with cemiplimab

Group III: Part 2 Arm 1B [2] (mCRPC) - expansion cohortExperimental Treatment1 Intervention

Following progression after BNT112 monotherapy, patients in Arm 1b have the option to be treated with cemiplimab monotherapy Enrollment into this arm is completed.

Group IV: Part 2 Arm 1B [1] (mCRPC) - expansion cohortExperimental Treatment1 Intervention

BNT112 monotherapy Enrollment into this arm is completed.

Group V: Part 2 Arm 1A (mCRPC) - expansion cohortExperimental Treatment2 Interventions

BNT112 in combination with cemiplimab Enrollment into this arm is completed.

Group VI: Part 1 (mCRPC) - dose titrationExperimental Treatment1 Intervention

BNT112 monotherapy Enrollment into this arm is completed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

0 / 17Eligibility 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

Common treatments for prostate cancer include immunotherapies like cancer vaccines and PD-1 inhibitors. Cancer vaccines, such as BNT112, work by stimulating the immune system to recognize and attack cancer cells. PD-1 inhibitors, like cemiplimab, enhance the immune response by blocking the PD-1 pathway, which cancer cells use to evade immune detection. These treatments are important for prostate cancer patients as they offer a targeted approach to boost the body's natural defenses, potentially improving outcomes and reducing side effects compared to traditional therapies.

Novel Redirected T-Cell Immunotherapies for Advanced Prostate Cancer.