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

Purpose

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

Condition

  • Nasopharyngeal Cancer Recurrent

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Toripalimab + cisplatin (or carboplatin) + 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.
  • Drug: Toripalimab
    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.
    Other names:
    • JS001
    • TAB-001
    • CHS-007
  • Drug: Cisplatin
    Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
  • Drug: Gemcitabine
    Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
  • Drug: Carboplatin
    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.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Samantha Reilly
617-638-8271
samantha.reilly@bmc.org

More Details

Status
Recruiting
Sponsor
Coherus Biosciences, Inc.

Study Contact

Sandy Paige, Director, Clinical Operations
800-794-5434
spaige@coherus.com

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).