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BNT113 + Pembrolizumab for Head and Neck Cancers (AHEAD-MERIT Trial)

Phase 2
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have a tumor expressing PD-L1 [CPS ≥1] as determined by the FDA-approved test PD-L1 22C3 pharmDx kit
The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology)
Must not have
Patients with uncontrolled intercurrent illness, including but not limited to: ongoing or active infection which requires systemic treatment with antibiotics or corticoid therapy within 14 days before the first dose of trial treatment, symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), myocardial infarction within 3 months before screening, unstable angina pectoris, or cardiac arrhythmia, arterial thrombosis or pulmonary embolism within ≤6 months before the start of trial treatment, known recent history (in the past 5 years) or presence of significant pulmonary conditions such as uncontrolled chronic lung disease, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis, uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management, known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T negative severe combined immunodeficiency [SCID]) or combined T and B cell immunodeficiencies (e.g., T and B negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
Patients with a known allergy, hypersensitivity, or intolerance to BNT113 or its excipients, or to pembrolizumab or its excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination therapy as a potential treatment for head and neck cancer.

Who is the study for?
Adults over 18 with a specific head and neck cancer (HPV16+ HNSCC) that can't be removed by surgery or has spread, and whose tumors express the PD-L1 protein. Participants must have good liver, kidney, bone marrow function, not had certain treatments before, and women of childbearing age need a negative pregnancy test.
What is being tested?
The trial is testing BNT113 combined with pembrolizumab against pembrolizumab alone in patients with HPV16+ HNSCC expressing PD-L1. It's an open-label Phase II study with two parts: initial safety confirmation followed by randomized efficacy comparison.
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions like fever or chills, fatigue, nausea, skin rash or itching. Each person may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is PD-L1 positive as per the FDA-approved test.
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My cancer originates in the throat, mouth, or voice box, but not in the upper part of the throat behind the nose.
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I can provide a sample of my tumor tissue for the trial.
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My cancer is HPV16+ and has returned or spread, and cannot be cured with surgery or radiation.
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My kidney function is good, with a filtration rate of at least 45 mL/min.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe ongoing illnesses or recent major heart issues.
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I am not allergic to BNT113, pembrolizumab, or their ingredients.
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I haven't had major surgery in the last 4 weeks, am fully recovered, and have no surgeries planned during the trial.
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I have a wound or ulcer that is not healing, or a broken bone.
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I have not had serious gut issues like diverticulitis or blockages in the last 3 years.
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My adrenal insufficiency is not under control.
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My Type 1 diabetes is not under control.
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My cancer originated in the nasopharynx.
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I have had my spleen removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab
Part B - Overall Survival (OS)
Part B - Overall response rate (ORR) assessed by blinded independent central review (BICR)
Secondary study objectives
Duration of Response (DOR)
Overall response rate (ORR) by investigator's assessment
Part A - Disease control rate (DCR)
+3 more
Other study objectives
PRO EORTC Quality of life - Head and Neck Cancer Module (QLQ-H&N35)
Patient-reported outcome (PRO) EORTC Quality of Life Questionnaire Core 30 (QLQ-C30)
Time to deterioration in PRO scores EORTC QLQ-C30
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part B (Randomized phase) - BNT113 + PembrolizumabExperimental Treatment2 Interventions
BNT113 in combination with pembrolizumab.
Group II: Part A (Safety run-In) - BNT113 + PembrolizumabExperimental Treatment2 Interventions
Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.
Group III: Part B (Randomized phase) - Pembrolizumab monotherapyActive Control1 Intervention
Pembrolizumab monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BNT113
2017
Completed Phase 2
~40
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
72 Previous Clinical Trials
112,224 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,703 Total Patients Enrolled

Media Library

BNT113 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04534205 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Part A (Safety run-In) - BNT113 + Pembrolizumab, Part B (Randomized phase) - BNT113 + Pembrolizumab, Part B (Randomized phase) - Pembrolizumab monotherapy
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: BNT113 Highlights & Side Effects. Trial Name: NCT04534205 — Phase 2
BNT113 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534205 — Phase 2
~134 spots leftby May 2028
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