Nasopharyngeal Cancer Recurrent
Conditions
Keywords
Programmed death 1 [PD1] inhibitor, Toripalimab, Recurrent metastatic nasopharyngeal cancer
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).
Interventions
DRUGToripalimab
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.
DRUGCisplatin
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
DRUGGemcitabine
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
DRUGCarboplatin
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.
Sponsors
Coherus Oncology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| DoR assessed by the investigator according to RECIST v1.1 | Up to 24 months |
| Progression-free Survival (PFS) assessed by BICR 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 |
| 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 |
| Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve | 12 months, 24 months |
Countries
Canada, United States
Contacts
CONTACTClinical Operations Team Clinical Operations
STUDY_DIRECTORStudy Director
Coherus Oncology
Outcome results
None listed