Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-01 @ 6:30 AM
Study NCT ID:
NCT05027633
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To increase overall response rate (ORR)', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'To improve the following efficacy endpoints relative to historical results with chemotherapy alone', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma', 'the Nasal Cavity', 'Paranasal Sinuses']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity/paranasal sinuses (PNS SCC).', 'detailedDescription': 'Primary Objective\n\n-Increase overall response rate (ORR), following pembrolizumab combined with induction chemotherapy prior to radiation, from historical 60% with induction chemotherapy alone to 80%.\n\nSecondary Objective\n\n* Improve the following efficacy endpoints relative to historical results with chemotherapy alone: progression free survival (PFS), overall survival (OS), organ \\[orbital, maxillary, cranial\\] preservation rate (OPR), and locoregional failure (LRF).\n* To determine safety and tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC.\n* Correlate immune phenotype in tumors and blood, including T cell infiltration and PD-L1 status, with treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and/or cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.\n* Male participants:\n\nA male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n-Female participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.\n\n * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n * Have measurable disease based on RECIST 1.1.\n * Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Patients must not have received prior systemic anti-cancer therapy including investigational agents or radiation therapy for PNS SCC but could have received treatment for prior cancers if greater than 2 years (refer to Item 8 for further details).'}, 'identificationModule': {'nctId': 'NCT05027633', 'briefTitle': 'Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)', 'orgStudyIdInfo': {'id': '2020-1109'}, 'secondaryIdInfos': [{'id': 'NCI-2021-09409', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Reporting Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pembrolizumab, docetaxel, and cisplatin or carboplatin', 'description': 'IV', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Docetaxel', 'Drug: Cisplatin', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'given by IV', 'armGroupLabels': ['pembrolizumab, docetaxel, and cisplatin or carboplatin']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'given by IV', 'armGroupLabels': ['pembrolizumab, docetaxel, and cisplatin or carboplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'given by IV', 'armGroupLabels': ['pembrolizumab, docetaxel, and cisplatin or carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'given by IV', 'armGroupLabels': ['pembrolizumab, docetaxel, and cisplatin or carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renata Ferrarotto', 'role': 'CONTACT', 'email': 'rferrarotto@mdanderson.org', 'phone': '713-745-6774'}, {'name': 'Renata Ferrarotto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Renata Ferrarotto', 'role': 'CONTACT', 'email': 'rferrarotto@mdanderson.org', 'phone': '(713) 745-6774'}], 'overallOfficials': [{'name': 'Renata Ferrarotto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}