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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04534205
Registration number
NCT04534205
Ethics application status
Date submitted
27/08/2020
Date registered
1/09/2020
Date last updated
11/07/2025
Titles & IDs
Public title
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
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Scientific title
An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1
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Secondary ID [1]
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2020-001400-41
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Secondary ID [2]
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BNT113-01
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Universal Trial Number (UTN)
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Trial acronym
AHEAD-MERIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unresectable Head and Neck Squamous Cell Carcinoma
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Metastatic Head and Neck Cancer
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Recurrent Head and Neck Cancer
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Infection
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Other infectious diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BNT113
Treatment: Other - Pembrolizumab
Experimental: Part A (Safety Run-In) - BNT113 + Pembrolizumab - Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.
Experimental: Part B (Randomized phase) - BNT113 + Pembrolizumab - BNT113 in combination with pembrolizumab.
Active comparator: Part B (Randomized phase) - Pembrolizumab monotherapy - Pembrolizumab monotherapy.
Treatment: Other: BNT113
IV injection
Treatment: Other: Pembrolizumab
IV infusion
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab
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Assessment method [1]
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TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade =3, serious, and fatal TEAEs, by relationship.
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Timepoint [1]
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up to 27 months
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Primary outcome [2]
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Part B - Overall survival (OS)
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Assessment method [2]
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OS defined as the time from randomization to death from any cause.
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Timepoint [2]
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up to 48 months
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Primary outcome [3]
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Part B - Progression-free survival (PFS)
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Assessment method [3]
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PFS defined as the time from randomization to the first objective tumor progression (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] assessed by the blinded independent central review \[BICR\]), or death from any cause, whichever occurs first.
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Timepoint [3]
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up to 48 months
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Secondary outcome [1]
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Part A and B - Overall response rate (ORR)
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Assessment method [1]
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ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per RECIST 1.1 assessed by BICR and investigator) is observed as best overall response.
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Timepoint [1]
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up to 48 months
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Secondary outcome [2]
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Part A and B - Duration of response (DOR)
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Assessment method [2]
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DOR defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease \[PD\] per RECIST 1.1) or death from any cause, whichever occurs first. In Part A, assessment will be done by both BICR and investigator; in Part B, only by BICR.
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Timepoint [2]
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up to 48 months
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Secondary outcome [3]
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Part A - Disease control rate (DCR)
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Assessment method [3]
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DCR defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, assessed at least 6 weeks after first dose by BICR and investigator) is observed as best overall response.
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Timepoint [3]
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up to 48 months
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Secondary outcome [4]
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Part B - Progression free survival (PFS)
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Assessment method [4]
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PFS defined as the time from randomization to the first objective tumor progression (per RECIST 1.1 by investigator's assessment) or death from any cause, whichever occurs first.
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Timepoint [4]
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up to 48 months
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Secondary outcome [5]
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Part B - PFS rate at 6 months
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Assessment method [5]
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Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause
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Timepoint [5]
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from randomization until 6 months after randomization
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Secondary outcome [6]
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Part B - PFS rate at 12 months
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Assessment method [6]
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Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause.
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Timepoint [6]
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from randomization until 12 months after randomization
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Secondary outcome [7]
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Part B - Occurrence of TEAEs - BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy
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Assessment method [7]
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TEAEs assessed according to CTCAE v5.0 including Grade =3, serious, and fatal TEAEs by relationship.
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Timepoint [7]
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up to 27 months
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Secondary outcome [8]
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Part B - Occurrence of dose reduction, delay, and discontinuation of trial treatments due to TEAEs
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Assessment method [8]
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BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy.
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Timepoint [8]
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up to 27 months
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Eligibility
Key inclusion criteria
Key
* Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.
* Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.
* Patients who have a tumor that expresses PD-L1 [CPS =1] as determined by the European Conformity (CE)-marked/Food and Drug Administration-approved CDx PD-L1 immunohistochemistry 22C3 pharmDx performed according to the manufacturer's instructions for use.
* Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 180 days prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.
* Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been demonstrated in such lesions disease by RECIST 1.1.
* All patients must provide a tumor tissue sample (formalin fixed paraffin embedded [FFPE] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy sample is performed as part of the patient's standard clinical practice before the first dose of trial treatment. The sample should be preferably derived from a current site of metastatic or recurrent disease. Otherwise, a sample from the primary tumor can be submitted.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Medical conditions:
* Patients present primary tumor site of nasopharynx (any histology).
* Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ).
Prior/concomitant therapy:
* Patients who have received or currently receive the following therapy/medication:
1. Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone >10 mg daily orally [PO] or intravenously [IV], or equivalent) in the 7 days prior to the first dose of trial treatment.
2. Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated AEs that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment.
3. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113.
4. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or five half-lives of the agent (whichever is longer) before the planned first dose of BNT113.
5. Ongoing treatment with therapeutic PO or IV antibiotics. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) may be enrolled.
* Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or five half-lives of the agent (whichever is longer) before the first dose of BNT113.
* Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization. Note: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate, zoledronic acid) and denosumab, is allowed.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2029
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Actual
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Sample size
Target
350
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cancer Research SA - Adelaide
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Bankstown-Lidcombe Hospital - Bankstown
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Flinders Medical Centre - Bedford Park
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Coffs Harbour Hospital - Coffs Harbour
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St Vincent's Hospital - Fitzroy
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Royal North Shore Hospital - Saint Leonards
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John Flynn Private Hospital - Tugun
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Southern Medical Day Care Centre - Wollongong
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5000 - Adelaide
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2200 - Bankstown
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5042 - Bedford Park
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2450 - Coffs Harbour
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VIC 3065 - Fitzroy
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2065 - Saint Leonards
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4224 - Tugun
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Recruitment postcode(s) [8]
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2500 - Wollongong
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Recruitment outside Australia
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Ciudad De México
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Oaxaca de Juarez
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Mexico
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Veracruz
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Mexico
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Yucatán
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Konin
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Kraków
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Poland
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Poznan
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Poland
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Wroclaw
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Gaia
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Portugal
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Lisboa
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Portugal
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Porto
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Jaén
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Malaga
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Goteborg
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Sweden
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Lund
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Sweden
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Umeå
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Taiwan
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Changhua
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Edirne
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Istanbul
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Turkey
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Izmir
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Malatya
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Turkey
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Yüregir
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United Kingdom
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Aberdeen
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United Kingdom
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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Preston
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United Kingdom
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Southampton
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United Kingdom
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Stevenage
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United Kingdom
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Sutton
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Funding & Sponsors
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Commercial sector/industry
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Name
BioNTech SE
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Summary
Brief summary
An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) =1. This trial has two parts. Part A, is an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS =1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. Patients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.
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Trial website
https://clinicaltrials.gov/study/NCT04534205
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Contacts
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BioNTech Responsible Person
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BioNTech SE
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Contact person for public queries
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BioNTech clinical trials patient information
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Phone
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+49 6131 9084
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04534205
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