BNT111 + Cemiplimab for Melanoma

Recruiting at 64 trial locations

Overseen By BioNTech clinical trial information desk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioNTech SE

Must be taking: Anti-PD-1/PD-L1

Must not be taking: Systemic immunosuppressants, Steroids

Disqualifiers: Pregnancy, Autoimmune disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

184 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic immune suppression medications or have had recent cancer treatments like chemotherapy or radiotherapy before starting the trial.

What makes the drug combination BNT111 and Cemiplimab unique for treating melanoma?

The combination of BNT111 and Cemiplimab is unique because it combines a cancer vaccine (BNT111) with an immune checkpoint inhibitor (Cemiplimab), potentially enhancing the immune system's ability to target and destroy melanoma cells more effectively than using either treatment alone. ^{1 2 3 4 5}

What data supports the effectiveness of the drug combination BNT111 and Cemiplimab for treating melanoma?

While there is no direct data on BNT111 and Cemiplimab, similar combination therapies in melanoma, like BRAF and MEK inhibitors, have shown improved survival rates. Additionally, immune-modulating drugs targeting PD-1, like Cemiplimab, have demonstrated durable responses in melanoma by enhancing the body's immune response against tumors. ^{2 6 7 8 9}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women of childbearing potential must have a negative pregnancy test at the start of the study.

Any initial signs of disease getting worse on a scan need to be confirmed by a specialized group of experts.

My liver is functioning well.

Exclusion Criteria

Presence of a severe concurrent illness or other condition that does not permit adequate follow-up and compliance with the protocol

I do not have any known immune system deficiencies.

You have recently developed or growing cancer in your brain or spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT111 and/or cemiplimab based on randomization. Patients in single agent arms may switch to combination therapy upon disease progression.

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

• BNT111
• Cemiplimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Cemiplimab monotherapy Experimental Treatment 1 Intervention

Group II: BNT111 monotherapy Experimental Treatment 1 Intervention

Group III: BNT111 + cemiplimab Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

The FDA approved two groundbreaking drugs for malignant melanoma in 2011, marking a significant advancement in treatment after a 13-year gap, specifically ipilimumab for immune checkpoint modulation and targeted therapies like vemurafenib and dabrafenib for BRAF(V600) mutations.

These new therapies have changed the landscape of melanoma treatment, but they also raise important questions about how to best combine and sequence these agents for patients with BRAF mutant melanoma to enhance efficacy and manage resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ipilimumab, vemurafenib, dabrafenib, and trametinib: synergistic competitors in the clinical management of BRAF mutant malignant melanoma. Luke, JJ., Hodi, FS.[2021]

Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.

In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. Hersey, P., Gowrishankar, K.[2017]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Ipilimumab, vemurafenib, dabrafenib, and trametinib: synergistic competitors in the clinical management of BRAF mutant malignant melanoma. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Combinatorial Therapies in Melanoma: MAPK Inhibitors and Beyond. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Vemurafenib plus cobimetinib in the treatment of mutated metastatic melanoma: the CoBRIM trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Future perspectives in melanoma research: meeting report from the "Melanoma Bridge": Napoli, December 3rd-6th 2014. [2019]

5. England pubmed.ncbi.nlm.nih.gov

New drugs in melanoma: it's a whole new world. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The oncogenic BRAF kinase inhibitor PLX4032/RG7204 does not affect the viability or function of human lymphocytes across a wide range of concentrations. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Immune Checkpoint Therapies for Melanoma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Ceritinib Enhances the Efficacy of Trametinib in BRAF/NRAS-Wild-Type Melanoma Cell Lines. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]