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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
Study Summary
This trial is designed to see if a combination of two drugs is more effective than either drug alone in treating patients with melanoma that has spread and is no longer responding to other treatments.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Select...
My melanoma is at an advanced stage and cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) - Arm: BNT111 + cemiplimab
Secondary outcome measures
Changes in laboratory parameters (clinical chemistry) compared to baseline
Changes in laboratory parameters (coagulation factors) compared to baseline
Changes in laboratory parameters (endocrine tests) compared to baseline
+35 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) 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
Find a Location
Who is running the clinical trial?
BioNTech SELead Sponsor
64 Previous Clinical Trials
107,497 Total Patients Enrolled
4 Trials studying Melanoma
1,809 Patients Enrolled for Melanoma
Regeneron PharmaceuticalsIndustry Sponsor
617 Previous Clinical Trials
380,021 Total Patients Enrolled
13 Trials studying Melanoma
5,006 Patients Enrolled for Melanoma
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,572 Total Patients Enrolled
2 Trials studying Melanoma
191 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women of childbearing potential must have a negative pregnancy test at the start of the study.I am 18 years old or older.I do not have any known immune system deficiencies.Any initial signs of disease getting worse on a scan need to be confirmed by a specialized group of experts.You have recently developed or growing cancer in your brain or spine.Any side effects from previous trial medications have mostly gone away.My liver is functioning well.I have a history of serious heart problems.My kidney function is adequate, with an eGFR of 30 mL/min or higher.I have signed a new consent form to continue with additional treatment.I will use birth control during and for 6 months after the trial.I do not have an uncontrolled HIV, hepatitis B, or hepatitis C infection.I have had 1 to 5 treatments for my advanced disease.My cancer's growth was confirmed by two scans or one if I had new symptoms.I haven't had any cancer treatment in the last 3 weeks.I do not have any major health issues that could affect my trial participation.I am fully active or can carry out light work.I can provide the necessary biopsy samples.I do not have uncontrolled type 1 diabetes or adrenal insufficiency.I have had my spleen removed.Women who could become pregnant must have a negative pregnancy test at the initial screening.I have previously been treated with BNT111 or cemiplimab.I haven't taken antibiotics for an infection in the last 2 weeks.I haven't had a serious autoimmune disease needing strong immune system drugs in the last 5 years.I have not used immune-suppressing drugs in the last 3 months.Inclusion criteria for entering add-on therapy means the specific requirements you need to meet in order to be eligible for additional treatment.I am a man who can father a child and will use barrier contraception.You have tried the study drug alone in arm 2 or 3 and your disease got worse.Your LDH level in the blood should be within the normal range.You have had a bad reaction to the main ingredients or other parts of the study drug.You are currently taking medication that weakens your immune system.I know my cancer's BRAF mutation status.I have another cancer that has not been fully in remission for 2 years.I have not received a live vaccine in the last 28 days.I don't have severe side effects from previous cancer treatments.I had major surgery less than 4 weeks ago.I have new or worsening brain or spinal cancer spread.My melanoma has worsened after treatment with anti-PD-1/PD-L1 drugs.My blood tests show my bone marrow is working well.I have never had melanoma in my eyes, palms, soles, or mucous membranes.My melanoma is at an advanced stage and cannot be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Cemiplimab monotherapy
- Group 2: BNT111 + cemiplimab
- Group 3: BNT111 monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the qualifying symptoms able to enroll in this study?
"Yes, this is an ongoing recruitment drive as indicated by the clinicaltrials.gov website. The clinical trial was first posted on May 19th, 2021 and updated on September 8th, 2022. Currently, the trial is looking for 180 participants from 14 different locations."
Answered by AI
Are there any Canadian hospitals conducting this research?
"Currently, there are a total of 14 locations where this clinical trial is taking place. They are in Fairfax, Tucson, Omaha, and 14 other cities. To avoid having to travel long distances, it is best to choose a location near you."
Answered by AI
What is the status of BNT111's FDA approval?
"While there is not yet data indicating that BNT111 is effective, there is some evidence that it is safe. Our team at Power rated the safety a 2."
Answered by AI
Do we have any previous research to draw from regarding BNT111?
"Currently, there are 59 different ongoing studies investigating BNT111. 4 of these trials are in Phase 3. The largest concentration of these clinical trials is in Barcelona and California. However, there are a total of 1771 locations running these trials."
Answered by AI
What are the primary conditions that BNT111 has been shown to be effective for?
"BNT111 is frequently used to treat the alk gene mutation. However, it is also an effective medication for other health concerns such as advance directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."
Answered by AI
How many individuals are experiencing this trial?
"One hundred and eighty patients are required to fulfil the obligations of the study. The sponsor, Regeneron Pharmaceuticals, have selected various locations across America to administer the trial, such as the University Of Arizona College Of Medicine in Tucson, Arizona and Inova Dwight and Martha Schar Cancer Institute in Fairfax, Virginia."
Answered by AI
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