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

April 3, 2026 updated by: Coherus Oncology, Inc.

Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Toronto, Canada, MSG 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Anna Spreafico, MD, PhD
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
        • Principal Investigator:
          • Santanu Samanta, MD
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
        • Principal Investigator:
          • Bao-An Huynh
      • San Francisco, California, United States, 94115
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Peter C Everett, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Paul Swiecicki, MD
        • Contact:
          • Cancer Answer Line
          • Phone Number: 800-865-1125
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthew Wilkins, MD
    • New York
      • New York, New York, United States, 10016
        • Withdrawn
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
        • Principal Investigator:
          • Trisha M Wise-Draper, M.D., Ph.D.
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Tamara Sussman, MD
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center
        • Principal Investigator:
          • Danh Pham, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Principal Investigator:
          • Stuart Wong, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Up to 24 months
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DoR) assessed by BICR according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
ORR assessed by the investigator according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
DoR assessed by the investigator according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
PFS assessed by the investigator according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
Overall Survival (OS) defined as time from enrollment to death due to any cause
Time Frame: Up to 42 months
Up to 42 months
Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
DCR assessed by the investigator according to RECIST v1.1
Time Frame: Up to 24 months
Up to 24 months
Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve
Time Frame: 12 months, 24 months
12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherus Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHS-007-01/RTOG 3521

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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