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

NCT06457503 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CHS-007-01/RTOG 3521
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 13

Brief Summary

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

Conditions

Nasopharyngeal Cancer Recurrent

Keywords

Programmed death 1 [PD1] inhibitor; Toripalimab; Recurrent metastatic nasopharyngeal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

Toripalimab + cisplatin (or carboplatin) + gemcitabine

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

Interventions

Toripalimab DRUG

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.

Also known as: JS001, TAB-001, CHS-007

Toripalimab + cisplatin (or carboplatin) + gemcitabine

Cisplatin DRUG

Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.

Toripalimab + cisplatin (or carboplatin) + gemcitabine

Gemcitabine DRUG

Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.

Toripalimab + cisplatin (or carboplatin) + gemcitabine

Carboplatin DRUG

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.

Toripalimab + cisplatin (or carboplatin) + gemcitabine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead

Study Sites (13)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94115, United States

RECRUITING

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Cancer Center

Detroit, Michigan, 48202, United States

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Princess Margaret Cancer Centre

Toronto, MSG 1Z5, Canada

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

toripalimab; Cisplatin; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Central Study Contacts

Clinical Operations Team Clinical Operations

CONTACT

800-794-5434; clinicaltrials@coherus.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (12); CA (1)