Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:44 PM
Study NCT ID:
NCT06457503
Status:
RECRUITING
Last Update Posted:
2025-10-21
First Post:
2024-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1', 'timeFrame': 'Up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR) assessed by BICR according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'ORR assessed by the investigator according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'DoR assessed by the investigator according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'PFS assessed by the investigator according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'Overall Survival (OS) defined as time from enrollment to death due to any cause', 'timeFrame': 'Up to 42 months'}, {'measure': 'Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'DCR assessed by the investigator according to RECIST v1.1', 'timeFrame': 'Up to 24 months'}, {'measure': 'Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve', 'timeFrame': '12 months, 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed death 1 [PD1] inhibitor', 'Toripalimab', 'Recurrent metastatic nasopharyngeal cancer'], 'conditions': ['Nasopharyngeal Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.', 'detailedDescription': 'The primary objective of this study is to evaluate the efficacy of toripalimab in combination with chemotherapy (cisplatin and gemcitabine), as measured by objective response rate (ORR) assessed by a Blinded Independent Central Review Committee (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in first-line recurrent metastatic nasopharyngeal cancer participants (both Epstein-Barr virus (EBV) and non-EBV-associated).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histological or cytological confirmation of recurrent/metastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:\n\n * EBER/EBV-negative (HPV+/-)\n * EBER/EBV-positive (HPV+/-)\n* Recurrent/metastatic (stage IV-B as defined by the International Union against Cancer \\[UICC\\] and American Joint Committee on Cancer \\[AJCC\\] staging system for nasopharyngeal cancer \\[NPC\\], eighth edition) or recurrent NPC after curative treatment. For recurrent NPC, more than 6 months between the last dose of radiotherapy or chemotherapy and the date of recurrence.\n* Measurable disease based on RECIST v 1.1 as determined by the site. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nKey Exclusion Criteria:\n\n* Disease that is suitable for local therapy administered with curative intent.\n* Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.\n* Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.\n* Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal), as determined on computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Participants who have prior therapies for brain or leptomeningeal metastasis and have been stabilized ≥ 1 month and have discontinued systemic steroid therapy (\\>10 mg/day prednisone or equivalent) ≥ 1 month prior to enrollment are eligible.\n\nOther protocol-defined inclusion and exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06457503', 'acronym': 'TRANSPARENT', 'briefTitle': 'A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coherus Oncology, Inc.'}, 'officialTitle': 'Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants', 'orgStudyIdInfo': {'id': 'CHS-007-01/RTOG 3521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toripalimab + cisplatin (or carboplatin) + gemcitabine', 'description': 'Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.', 'interventionNames': ['Drug: Toripalimab', 'Drug: Cisplatin', 'Drug: Gemcitabine', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Toripalimab', 'type': 'DRUG', 'otherNames': ['JS001', 'TAB-001', 'CHS-007'], 'description': 'Participants will receive toripalimab via intravenous infusion (IV) on Day 1 every 3 weeks (Q3W) during the Chemotherapy-based treatment phase and Maintenance treatment phase.', 'armGroupLabels': ['Toripalimab + cisplatin (or carboplatin) + gemcitabine']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.', 'armGroupLabels': ['Toripalimab + cisplatin (or carboplatin) + gemcitabine']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.', 'armGroupLabels': ['Toripalimab + cisplatin (or carboplatin) + gemcitabine']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'In the event of cisplatin-related nephrotoxicity or at the discretion of the investigator due to cisplatin-related poor tolerability, carboplatin can substitute for cisplatin use from cycle 2 onward. These participants will receive carboplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.', 'armGroupLabels': ['Toripalimab + cisplatin (or carboplatin) + gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Constance Brown', 'role': 'CONTACT', 'email': 'brownconstance@uams.edu'}, {'name': 'Santanu Samanta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shirin Attarian', 'role': 'CONTACT', 'email': 'sattari1@hs.uci.edu'}, {'name': 'Bao-An Huynh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luchia Andemicael', 'role': 'CONTACT', 'email': 'Luchia.Andemicael@ucsf.edu'}, {'name': 'Brittany Liu', 'role': 'CONTACT', 'email': 'Brittany.Liu@ucsf.edu'}, {'name': 'Sue S Yom, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Stallings', 'role': 'CONTACT', 'email': 'madison.miller.stallings@emory.edu'}, {'name': 'Dong Shin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samantha Reilly', 'role': 'CONTACT', 'email': 'samantha.reilly@bmc.org', 'phone': '617-638-8271'}, {'name': 'Peter C Everett, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cancer Answer Line', 'role': 'CONTACT', 'phone': '800-865-1125'}, {'role': 'CONTACT', 'email': 'CancerAnswerLine@med.umich.edu'}, {'name': 'Paul Swiecicki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'CancerTrials@nyulangone.org'}, {'name': 'Ruth White, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laura & Isaac Perlmutter Cancer Center at NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Audrey Romano', 'role': 'CONTACT', 'email': 'cragoay@ucmail.uc.edu'}, {'name': 'Trisha M Wise-Draper, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bridget Bush', 'role': 'CONTACT', 'email': 'bushb@ccf.org'}, {'name': 'Tamara Sussman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Kaehny', 'role': 'CONTACT', 'email': 'skaehny@mcw.edu'}, {'name': 'Stuart Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Froedtert Hospital and the Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'MSG 1Z5', 'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Arundhati Shukla', 'role': 'CONTACT', 'email': 'Arundhati.shukla@uhn.ca'}, {'name': 'Anna Spreafico, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Clinical Operations Team Clinical Operations', 'role': 'CONTACT', 'email': 'clinicaltrials@coherus.com', 'phone': '800-794-5434'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coherus Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}