A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer

Phase 4

Recruiting

• Conditions: Nasopharyngeal Cancer Recurrent
• Interventions: Drug: Toripalimab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

• 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 n...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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.

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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 (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States