Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04534205
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2020-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab', 'timeFrame': 'up to 27 months', 'description': '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.'}, {'measure': 'Part B - Overall survival (OS)', 'timeFrame': 'up to 48 months', 'description': 'OS defined as the time from randomization to death from any cause.'}, {'measure': 'Part B - Progression-free survival (PFS)', 'timeFrame': 'up to 48 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Part A and B - Overall response rate (ORR)', 'timeFrame': 'up to 48 months', 'description': '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.'}, {'measure': 'Part A and B - Duration of response (DOR)', 'timeFrame': 'up to 48 months', 'description': '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.'}, {'measure': 'Part A - Disease control rate (DCR)', 'timeFrame': 'up to 48 months', 'description': '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.'}, {'measure': 'Part B - Progression free survival (PFS)', 'timeFrame': 'up to 48 months', 'description': "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."}, {'measure': 'Part B - PFS rate at 6 months', 'timeFrame': 'from randomization until 6 months after randomization', 'description': 'Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause'}, {'measure': 'Part B - PFS rate at 12 months', 'timeFrame': 'from randomization until 12 months after randomization', 'description': 'Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause.'}, {'measure': 'Part B - Occurrence of TEAEs - BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy', 'timeFrame': 'up to 27 months', 'description': 'TEAEs assessed according to CTCAE v5.0 including Grade ≥3, serious, and fatal TEAEs by relationship.'}, {'measure': 'Part B - Occurrence of dose reduction, delay, and discontinuation of trial treatments due to TEAEs', 'timeFrame': 'up to 27 months', 'description': 'BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer vaccine', 'RNA vaccine', 'HNSCC', 'BNT113', 'Pembrolizumab', 'HPV16', 'Metastatic', 'Unresectable', 'Recurrent', 'Head and neck', 'mRNA vaccine', 'HPV-positive', 'Head and neck cancer'], 'conditions': ['Unresectable Head and Neck Squamous Cell Carcinoma', 'Metastatic Head and Neck Cancer', 'Recurrent Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': "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.\n\nThis trial has two parts.\n\nPart 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.\n\nPart 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.\n\nFor 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.\n\nPatients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.\n* Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.\n* 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.\n* 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.\n* 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.\n* 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.\n\nKey Exclusion Criteria:\n\nMedical conditions:\n\n* Patients present primary tumor site of nasopharynx (any histology).\n* 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).\n\nPrior/concomitant therapy:\n\n* Patients who have received or currently receive the following therapy/medication:\n\n 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.\n 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.\n 3. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113.\n 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.\n 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.\n* 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.\n* 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.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04534205', 'acronym': 'AHEAD-MERIT', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioNTech SE'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BNT113-01'}, 'secondaryIdInfos': [{'id': '2020-001400-41', 'type': 'EUDRACT_NUMBER'}, {'id': '2024-512671-12-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A (Safety Run-In) - BNT113 + Pembrolizumab', 'description': 'Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.', 'interventionNames': ['Biological: BNT113', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Randomized phase) - BNT113 + Pembrolizumab', 'description': 'BNT113 in combination with pembrolizumab.', 'interventionNames': ['Biological: BNT113', 'Biological: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B (Randomized phase) - Pembrolizumab monotherapy', 'description': 'Pembrolizumab monotherapy.', 'interventionNames': ['Biological: Pembrolizumab']}], 'interventions': [{'name': 'BNT113', 'type': 'BIOLOGICAL', 'description': 'IV injection', 'armGroupLabels': ['Part A (Safety Run-In) - BNT113 + Pembrolizumab', 'Part B (Randomized phase) - BNT113 + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'description': 'IV infusion', 'armGroupLabels': ['Part A (Safety Run-In) - BNT113 + Pembrolizumab', 'Part B (Randomized phase) - BNT113 + Pembrolizumab', 'Part B (Randomized phase) - Pembrolizumab monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA Cancer Care', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The George Washington Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University Cancer and Blood Center', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of New Mexico Comprehensive Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Cincinnati Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Providence Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'MultiCare Regional Cancer Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'B1884BBF', 'city': 'Berazategui', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Oncología e Investigación Buenos Aires COIBA', 'geoPoint': {'lat': -34.76531, 'lon': -58.21278}}, {'zip': '1280', 'city': 'Ciudad de Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Hospital Britanico de Buenos Aires'}, {'zip': 'X500AA1', 'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto de Oncologia de Cordoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '5300', 'city': 'La Rioja', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro Oncologico Riojano Integral', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': '2700', 'city': 'Pergamino', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Investigacion Pergamino SA - Clinica Pergamino', 'geoPoint': {'lat': -33.89101, 'lon': -60.57462}}, {'zip': '2000', 'city': 'Rosario', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto de Oncologia de Rosario', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Sanatorio Britanico', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'CAIPO Centro para la Atencion Integral del Paciente Oncologico', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '8500', 'city': 'Viedma', 'status': 'WITHDRAWN', 'country': 'Argentina', 'facility': 'Clinica Viedma', 'geoPoint': {'lat': -40.81519, 'lon': -63.0004}}, {'zip': '5000', 'city': 'Adelaide', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Cancer Research SA', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '2200', 'city': 'Bankstown', 'status': 'WITHDRAWN', 'country': 'Australia', 'facility': 'Bankstown-Lidcombe Hospital', 'geoPoint': {'lat': -33.91667, 'lon': 151.03333}}, {'zip': '5042', 'city': 'Bedford Park', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '2450', 'city': 'Coffs Harbour', 'status': 'WITHDRAWN', 'country': 'Australia', 'facility': 'Coffs Harbour Hospital', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'zip': 'VIC 3065', 'city': 'Fitzroy', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '2065', 'city': 'Saint Leonards', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -38.17051, 'lon': 144.71803}}, {'zip': '4224', 'city': 'Tugun', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'John Flynn Private Hospital', 'geoPoint': {'lat': -28.15, 'lon': 153.5}}, {'zip': '2500', 'city': 'Wollongong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Southern Medical Day Care Centre', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'LKH - Univ. Klinikum Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Landeskrankenhaus/ Univ.-Kliniken Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4010', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Uniklinikum Salzburg, Univ. 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