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Study of Toripalimab with Chemotherapy for Nasopharyngeal Cancer

This study is looking at how well a combination of medicines works for people with nasopharyngeal cancer that has come back or spread (recurrent metastatic). You would receive toripalimab along with chemotherapy drugs, cisplatin and gemcitabine, given through an IV. If cisplatin causes problems, carboplatin might be used instead. The main goal is to see how many participants have their tumors shrink or disappear (Objective Response Rate) over 24 months. You may be able to join if you are 12 years or older and have confirmed recurrent or metastatic nasopharyngeal cancer, regardless of whether it's linked to the EBV virus. The study plans to enroll about 100 people.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 100 participants.
What's involved
Participants will receive toripalimab, cisplatin, and gemcitabine (or carboplatin) through IV infusions every three weeks. The study will assess your tumor response for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Objective Response Rate, will be measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06457503

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

Recruiting
PHASE4Ages 12+InterventionalTreatment
Coherus Oncology, Inc.
~100 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:ToripalimabCisplatinGemcitabineCarboplatin

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Up to 24 months

Conditions

Nasopharyngeal Cancer Recurrent

Explore related trials

Nasopharyngeal Carcinoma

NCT06457503

Where you'd take part

This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Henry Ford Cancer Center

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvaniastudy coordinator listed

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Canada, Canadastudy coordinator listed

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · Coherus Oncology

Who to contact

Clinical Operations Team Clinical Operations
[email protected]
800-794-5434
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1Up to 24 months