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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

AHEAD-MERIT Trial 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.Check my eligibility
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.See study design
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.

AHEAD-MERIT Trial Eligibility Criteria

Inclusion Criteria

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

AHEAD-MERIT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Duration of Response (DOR)
Overall response rate (ORR) by investigator's assessment
Part A - Disease control rate (DCR)
+3 more
Other outcome measures
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

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

AHEAD-MERIT 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 2
~2010

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
107,413 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,499 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the regulatory body approved BNT113 for public use?

"BNT113's safety rating is 2, which reflects the fact that it has only been tested in phase 2 trials and there are no clinical results substantiating its efficacy."

Answered by AI

What medical indications commonly prompt the use of BNT113?

"BNT113 is used to treat cancerous tumours. It has also been known to be effective with managing cases of unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease progression."

Answered by AI

Is enrollment currently open for the trial?

"Affirmative. The information housed on clinicaltrials.gov indicates that the trial is currently enrolling participants, having been initially published in July 2021 and most recently updated in November 2022. This study requires 285 individuals to be selected from 11 different sites."

Answered by AI

What is the ultimate goal of this experiment?

"The purpose of this 48 month clinical trial is to assess the overall response rate (ORR) as evaluated by a blind independent central review team. Secondary objectives include measuring changes from baseline using PRO EORTC Quality of Life - Head and neck cancer Module questionnaire scores, tracking time until deterioration in PRO scores derived from an EORTC QLQ-C30 questionaire, and recording toxicity events associated with BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy based on CTCAE v5.0 including Grade ≥3, serious or fatal TEAEs."

Answered by AI

Could you please summarize the research that has been conducted with BNT113?

"BNT113 was initially researched at City of Hope a decade ago, with 251 studies culminating in their completion. Currently, there are 961 ongoing investigations related to this drug, the majority of which take place at Stanford and Georgia universities."

Answered by AI

What is the capacity of participants for this medical experiment?

"BioNTech SE, the sponsor of this study, requires 285 eligible participants in order to conduct the trial. These patients will be recruited from various medical centres such as Stanford Cancer Institute and Cross Cancer Institute located in Georgia and New york respectively."

Answered by AI

Are there any research centers in North America currently conducting this investigation?

"This trial is presently seeking participants at 11 locations including Stanford Cancer Institute, Cross Cancer Institute in Edmonton, and University Cancer and Blood Center. Moreover, there are several other sites currently recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
2021. "A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04534205.
~157 spots leftby May 2028
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