Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
Study NCT ID:
NCT04183166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2019-11-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)', 'timeFrame': 'Up to 2 Years.', 'description': 'Incidence of Adverse Event reported per CTCAE v5.'}, {'measure': 'Phase I/II: Disease-Free Survival', 'timeFrame': 'Up to 2 years.', 'description': 'Time from randomization to documented recurrence of disease.'}], 'secondaryOutcomes': [{'measure': 'Phase I: Disease-Free Survival', 'timeFrame': 'Up to 2 Years.', 'description': 'Time from randomization to documented recurrence of disease.'}, {'measure': 'Phase I: Tumor response rate', 'timeFrame': 'Up to 2 years.', 'description': 'Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.'}, {'measure': 'Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)', 'timeFrame': 'Up to 2 years.', 'description': 'Incidence of Adverse Event reported per CTCAE v5.'}, {'measure': 'Phase I/II: Distant Metastases-Free Survival', 'timeFrame': 'Up to 2 years.', 'description': 'Time from randomization to documented first occurrence of distant metastasis.'}, {'measure': 'Phase I/II: Loco-Regional Relapse-Free Survival', 'timeFrame': 'Up to 2 years.', 'description': 'Time from randomization to documented loco-regional recurrence.'}, {'measure': 'Phase I/II: Overall Response Rate in patients with recurrent disease', 'timeFrame': 'Up to 2 years.', 'description': 'Percentage of patients with a best overall response of complete response or partial response according to RECIST, version 1.1 criteria.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma of Head and Neck']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent\n2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx\n3. Female or male patients, aged at least 18 years\n4. Patients in Complete Response after treatment of their primary tumor.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n6. Adequate hematological, hepatic and renal functions\n\nExclusion Criteria:\n\n1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.\n2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.\n3. Other active malignancy requiring concurrent systemic intervention.\n4. Patients with previous malignancies other than the target malignancy to be investigated in this trial\n5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)\n6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection\n7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\\> 10 mIU/mL)\n8. Treatment with another investigational agent since the beginning of the screening period\n9. Uncontrolled intercurrent illness'}, 'identificationModule': {'nctId': 'NCT04183166', 'briefTitle': 'A Clinical Trial Evaluating TG4050 in Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transgene'}, 'officialTitle': 'A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.', 'orgStudyIdInfo': {'id': 'TG4050.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A : Early study treatment initiation', 'description': 'TG4050 treatment initiation at completion of primary treatment', 'interventionNames': ['Drug: TG4050']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Study treatment initiation at recurrence', 'description': 'TG4050 treatment initiation at the time of recurrence', 'interventionNames': ['Drug: TG4050']}], 'interventions': [{'name': 'TG4050', 'type': 'DRUG', 'description': 'Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks', 'armGroupLabels': ['Arm A : Early study treatment initiation', 'Arm B: Study treatment initiation at recurrence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Saint André - CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31100', 'city': 'Toulouse', 'country': 'France', 'facility': 'IUCT Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Vall d Hebrón', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Català d Oncologia - Hospital Duran i Reynals', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Málaga - Hospital Civil', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '15076', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': 'L7 8YA', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'NHS Clatterbridge Cancer Center', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Aintree University Hospital NHS Fondation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}