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Immunotherapy-Chemo cocktail shows promise for Tough-to-Treat throat cancer

NCT ID NCT06457503

Disease control Sponsor: Coherus Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 5 times

Summary

This study is testing whether adding the immunotherapy drug toripalimab to standard chemotherapy (cisplatin and gemcitabine) can help people with recurrent or metastatic nasopharyngeal cancer that hasn't been treated before. About 100 participants will receive the combination intravenously every three weeks. The main goal is to see how many patients' tumors shrink or disappear, with secondary goals looking at how long that effect lasts and how long people live without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
toripalimab (an immunotherapy drug) combined with cisplatin and gemcitabine (chemotherapy drugs)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with recurrent metastatic nasopharyngeal cancer, potentially improving response rates and delaying disease progression.
What could go wrong
This is a single-arm, non-randomized study, so results may be less reliable than a randomized trial. Side effects from chemotherapy and immunotherapy can be significant, and the treatment may not work for all participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma nasopharyngeal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasopharyngeal cancer recurrent

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Froedtert Hospital and the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Henry Ford Cancer Center

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    WITHDRAWN

    New York, New York, 10016, United States

  • Penn State Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Canada, MSG 1Z5, Canada

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

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