BNT111 + Cemiplimab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, BNT111 and cemiplimab (an immunotherapy drug), for individuals with advanced melanoma unresponsive to previous treatments. The researchers aim to assess the effectiveness and safety of these treatments, both individually and in combination. The trial targets those with unresectable Stage III or IV melanoma who have experienced disease progression despite prior immune therapies. Participants should have melanoma that cannot be surgically removed and has worsened after other treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BNT111 is generally well-tolerated, with most participants experiencing only mild to moderate flu-like symptoms. No major side effects required stopping the treatment.
Cemiplimab, already approved by the FDA for other uses, is generally considered safe. Some patients experienced immune-related side effects, which were mostly manageable. Serious side effects, such as inflammation of the colon, were rare and led to treatment discontinuation in less than 1% of cases.
When combined, BNT111 and cemiplimab demonstrated a safety profile similar to their individual studies. No major new safety concerns emerged from their combination.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for melanoma, which often include surgery, radiation, and chemotherapy, the investigational treatments BNT111 and cemiplimab offer a unique approach. BNT111 is designed to trigger the immune system to specifically target melanoma cells by recognizing certain cancer-related antigens, essentially training the body to fight the cancer on its own. Cemiplimab, on the other hand, is a type of immunotherapy called a PD-1 inhibitor, which blocks a pathway that tumors use to hide from the immune system. Researchers are excited about these treatments because they harness the body's natural defenses, potentially offering a more targeted and less invasive option compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research has shown that combining BNT111 and cemiplimab, one of the treatment arms in this trial, may help treat melanoma that hasn't responded to other treatments. Studies found that 18.1% of patients responded positively to this combination, which is encouraging. Another arm in this trial will test BNT111 alone, which has also significantly improved response rates in melanoma patients. Cemiplimab by itself, tested in a separate arm, has a strong record of reducing the risk of melanoma and other skin cancers returning. These results suggest that both treatments, whether used alone or together, could effectively manage advanced melanoma.23456
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