184 Participants Needed

BNT111 + Cemiplimab for Melanoma

Recruiting at 64 trial locations
Bc
Bc
Overseen ByBioNTech clinical trial information desk
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: BioNTech SE
Must be taking: Anti-PD-1/PD-L1
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 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.12345

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.16789

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.

Research Team

BR

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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.
See 20 more

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.
See 22 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cemiplimab monotherapyExperimental Treatment1 Intervention
Group II: BNT111 monotherapyExperimental Treatment1 Intervention
Group III: BNT111 + cemiplimabExperimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

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

References

Ipilimumab, vemurafenib, dabrafenib, and trametinib: synergistic competitors in the clinical management of BRAF mutant malignant melanoma. [2021]
Combinatorial Therapies in Melanoma: MAPK Inhibitors and Beyond. [2023]
Vemurafenib plus cobimetinib in the treatment of mutated metastatic melanoma: the CoBRIM trial. [2020]
Future perspectives in melanoma research: meeting report from the "Melanoma Bridge": Napoli, December 3rd-6th 2014. [2019]
New drugs in melanoma: it's a whole new world. [2022]
The oncogenic BRAF kinase inhibitor PLX4032/RG7204 does not affect the viability or function of human lymphocytes across a wide range of concentrations. [2021]
Immune Checkpoint Therapies for Melanoma. [2022]
Ceritinib Enhances the Efficacy of Trametinib in BRAF/NRAS-Wild-Type Melanoma Cell Lines. [2020]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
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