Recruiting

Toripalimab, Cisplatin, Gemcitabine

Sponsor:

Coherus Oncology, Inc.

Code:

NCT06457503

Conditions

Nasopharyngeal Cancer Recurrent

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Toripalimab

Cisplatin

Gemcitabine

Carboplatin

Study Details

Brief summary:

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

Conditions

Nasopharyngeal Cancer Recurrent

Study ID

NCT06457503

Start date

Nov 1, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Cisplatin

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

Gemcitabine

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

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Operations Team Clinical Operations

800-794-5434clinicaltrials@coherus.com

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Constance Brown

brownconstance@uams.edu

Principal Investigator:

Santanu Samanta, MD

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Shirin Attarian

sattari1@hs.uci.edu

Principal Investigator:

Bao-An Huynh

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Imani Dunn

415-476-7600imani.dunn@ucsf.edu

Principal Investigator:

Sue S Yom, MD

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Madison Stallings

madison.miller.stallings@emory.edu

Principal Investigator:

Dong Shin, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Samantha Reilly

617-638-8271samantha.reilly@bmc.org

Principal Investigator:

Peter C Everett, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer Answer Line

1-800-865-1125

CancerAnswerLine@med.umich.edu

Principal Investigator:

Paul Swiecicki, MD

Henry Ford Cancer Center

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Bethany Adams

248-224-7345badams19@HFHS.ORG

Principal Investigator:

Matthew Wilkins, MD

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Audrey Romano

cragoay@ucmail.uc.edu

Principal Investigator:

Trisha M Wise-Draper, M.D., Ph.D.

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Bridget Bush

bushb@ccf.org

Principal Investigator:

Tamara Sussman, MD

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

CI-CTO

717-531-5471psci-cto@pennstatehealth.psu.edu

Principal Investigator:

Danh Pham, MD

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Sarah Kaehny

skaehny@mcw.edu

Principal Investigator:

Stuart Wong, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Canada, Canada, MSG 1Z5

Contacts

Arundhati Shukla

Arundhati.shukla@uhn.ca

Principal Investigator:

Anna Spreafico, MD, PhD

More Information

Sponsor

Coherus Oncology, Inc.

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Coherus Oncology, Inc. on 2026-07-30.