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Trial Title:
A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
NCT ID:
NCT06457503
Condition:
Nasopharyngeal Cancer Recurrent
Conditions: Official terms:
Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Recurrence
Carboplatin
Gemcitabine
Conditions: Keywords:
Programmed death 1 [PD1] inhibitor
Toripalimab
Recurrent metastatic nasopharyngeal cancer
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
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.
Arm group label:
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Other name:
JS001
Other name:
TAB-001
Other name:
CHS-007
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based
treatment phase.
Arm group label:
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the
Chemotherapy-based treatment phase.
Arm group label:
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Intervention type:
Drug
Intervention name:
Carboplatin
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.
Arm group label:
Toripalimab + cisplatin (or carboplatin) + gemcitabine
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).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luchia Andemicael
Email:
Luchia.Andemicael@ucsf.edu
Contact backup:
Last name:
Brittany Liu
Email:
Brittany.Liu@ucsf.edu
Investigator:
Last name:
Sue S Yom, MD
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Coherus Biosciences, Inc.
Agency class:
Industry
Source:
Coherus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06457503
