A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
- Conditions
- Nasopharyngeal Cancer Recurrent
- Interventions
- Registration Number
- NCT06457503
- Lead Sponsor
- Coherus Biosciences, Inc.
- Brief Summary
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
Histological or cytological confirmation of recurrent/metastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:
- EBER/EBV-negative (HPV+/-)
- EBER/EBV-positive (HPV+/-)
-
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.
-
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.
Key
- Disease that is suitable for local therapy administered with curative intent.
- 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.
- Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
- 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.
Other protocol-defined inclusion and exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Toripalimab + cisplatin (or carboplatin) + gemcitabine Toripalimab 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. Toripalimab + cisplatin (or carboplatin) + gemcitabine Cisplatin 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. Toripalimab + cisplatin (or carboplatin) + gemcitabine Gemcitabine 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. Toripalimab + cisplatin (or carboplatin) + gemcitabine Carboplatin 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.
- Primary Outcome Measures
Name Time Method 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 Up to 24 months
- Secondary Outcome Measures
Name Time Method DoR assessed by the investigator according to RECIST v1.1 Up to 24 months Duration of Response (DoR) assessed by BICR according to RECIST v1.1 Up to 24 months ORR assessed by the investigator according to RECIST v1.1 Up to 24 months PFS assessed by the investigator according to RECIST v1.1 Up to 24 months Overall Survival (OS) defined as time from enrollment to death due to any cause Up to 42 months Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1 Up to 24 months Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve 12 months, 24 months Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1 Up to 24 months DCR assessed by the investigator according to RECIST v1.1 Up to 24 months
Trial Locations
- Locations (9)
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Emory Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
🇺🇸New York, New York, United States
Froedtert Hospital and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Canada