BNT111 + Cemiplimab for Melanoma
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?
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.26789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BNT111 and/or cemiplimab based on randomization. Patients in single agent arms may switch to combination therapy upon disease progression.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BNT111
- Cemiplimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
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
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