What side effects are associated with this type of intervention?

Common treatments for melanoma, such as immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and cancer vaccines targeting tumor-associated antigens, can cause a range of immune-related side effects. These include skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), and endocrine disorders (thyroid dysfunction, adrenal insufficiency). Less frequently, severe conditions like pneumonitis and hepatitis may occur. The severity of these side effects varies, requiring early diagnosis and appropriate management.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma, particularly those involving immune checkpoint inhibitors. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are anti-PD-1 monoclonal antibodies approved for advanced melanoma. Ipilimumab (Yervoy), an anti-CTLA-4 antibody, is also approved and often used in combination with nivolumab. While specific cancer vaccines targeting tumor-associated antigens like BNT111 are still under investigation, these immunotherapies represent significant advancements in melanoma treatment.

What other types of research exist?

Promising novel alternatives for melanoma treatment in 2024 include: 1) Anti-CTLA-4 antibody ipilimumab, especially in combination with PD-1 inhibitors like nivolumab, which has shown efficacy in treatment-naïve advanced melanoma. 2) Highly selective BRAF inhibitors such as PLX4032 for patients with BRAF mutations. 3) Experimental immunotherapies like chimeric antigen receptor (CAR)-T cell therapies, which are being tested in clinical trials. These alternatives offer potential synergies and improved outcomes for melanoma patients.

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Cancer Vaccine

BNT111 + Cemiplimab for Melanoma

Phase 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 be aged ≥ 18 years on the date of signing the informed consent

Patient should have adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation

Must not have

Patients must have no known primary immunodeficiencies, either cellular or combined T and B cell immunodeficiencies

History or current evidence of significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Summary

This trial tests a cancer vaccine (BNT111) and an immune-boosting drug (cemiplimab) in patients with advanced melanoma who haven't responded to standard treatments. The vaccine helps the immune system recognize cancer cells, and the drug enhances this immune response.

Who is the study for?

Adults with advanced melanoma that has worsened despite anti-PD-1/PD-L1 therapy can join this trial. They must have good liver, kidney, and bone marrow function, no other cancers in the last 2 years, not be pregnant or breastfeeding, and agree to use birth control. Excluded are those with certain severe illnesses or conditions, recent treatments or surgeries incompatible with the trial's requirements.

What is being tested?

The study is testing BNT111 and Cemiplimab together and separately in people whose melanoma hasn't responded to standard treatments. Participants will be randomly assigned to receive both drugs combined or just one of them alone. If a single drug doesn't work, they might get the chance to try adding the other after agreeing again.

What are the potential side effects?

Possible side effects include immune system reactions affecting different organs (like inflammation), infusion-related symptoms during treatment administration (such as fever or chills), fatigue, digestive issues like nausea or diarrhea, blood cell count changes which could affect immunity and healing.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My kidney function is adequate, with an eGFR of 30 mL/min or higher.

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I have had 1 to 5 treatments for my advanced disease.

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I am fully active or can carry out light work.

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I can provide the necessary biopsy samples.

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I know my cancer's BRAF mutation status.

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My melanoma has worsened after treatment with anti-PD-1/PD-L1 drugs.

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My melanoma is at an advanced stage and cannot be surgically removed.

Exclusion Criteria

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

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I do not have any known immune system deficiencies.

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I have a history of serious heart problems.

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

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I haven't had any cancer treatment in the last 3 weeks.

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I do not have uncontrolled type 1 diabetes or adrenal insufficiency.

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I have had my spleen removed.

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I have previously been treated with BNT111 or cemiplimab.

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I haven't taken antibiotics for an infection in the last 2 weeks.

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I haven't had a serious autoimmune disease needing strong immune system drugs in the last 5 years.

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I have another cancer that has not been fully in remission for 2 years.

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I don't have severe side effects from previous cancer treatments.

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I had major surgery less than 4 weeks ago.

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I have new or worsening brain or spinal cancer spread.

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I have never had melanoma in my eyes, palms, soles, or mucous membranes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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) - Arm: BNT111 + cemiplimab

Secondary study objectives

Disease control rate (DCR) according to RECIST 1.1

Duration of response (DOR) according to RECIST 1.1

Objective response rate - Arm: BNT111 monotherapy and Arm: Cemiplimab monotherapy

+13 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Hyperthyroidism

13%

Constipation

13%

Vomiting

13%

Nausea

13%

Diarrhoea

13%

Subcutaneous abscess

13%

Infusion related reaction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cemiplimab monotherapyExperimental Treatment1 Intervention

Group II: BNT111 monotherapyExperimental Treatment1 Intervention

Group III: BNT111 + cemiplimabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 22Eligibility 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 melanoma, such as cancer vaccines and anti-PD-1 monoclonal antibodies, work by enhancing the body's immune response against cancer cells. BNT111, a cancer vaccine, targets tumor-associated antigens to stimulate the immune system to recognize and attack melanoma cells. Cemiplimab, an anti-PD-1 monoclonal antibody, blocks the PD-1 pathway, which tumors use to evade immune detection, thereby boosting the immune system's ability to destroy cancer cells. These mechanisms are vital for melanoma patients as they provide targeted, potentially long-lasting treatment options, especially when other therapies are ineffective.

Recent Progress in Mutation-driven Therapy, Immunotherapy and Combination Therapy for the Treatment of Melanoma.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.