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Nasopharyngeal Cancer RecurrentPhase 4TRANSPARENTNCT06457503

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

A Phase 4 study testing Toripalimab, Cisplatin and Gemcitabine in people with Nasopharyngeal Cancer Recurrent, run by Coherus Oncology, Inc. at 13 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Nasopharyngeal Cancer Recurrent
What is being tested?
Toripalimab, Cisplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
13 sitesin 2 countries
Study dates
1 Nov 2024to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Operations Team Clinical Operations contact

800-794-5434

clinicaltrials@coherus.com

13 sites in 2 countries

United States12 sites, 11 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Cancer Answer Line, 1-800-865-1125

    CancerAnswerLine@med.umich.edu

    Recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Madison Stallings, madison.miller.stallings@emory.edu

    Dong Shin, MD

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Samantha Reilly, 617-638-8271, samantha.reilly@bmc.org

    Peter C Everett, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Audrey Romano, cragoay@ucmail.uc.edu

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

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Bridget Bush, bushb@ccf.org

    Tamara Sussman, MD

    Recruiting

  • Henry Ford Cancer Center

    Detroit, Michigan, 48202

    Bethany Adams, 248-224-7345, badams19@HFHS.ORG

    Matthew Wilkins, MD

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    CI-CTO, 717-531-5471, psci-cto@pennstatehealth.psu.edu

    Danh Pham, MD

    Recruiting

  • University of California, Irvine

    Irvine, California, 92697

    Shirin Attarian, sattari1@hs.uci.edu

    Bao-An Huynh

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Constance Brown, brownconstance@uams.edu

    Santanu Samanta, MD

    Recruiting

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Sarah Kaehny, skaehny@mcw.edu

    Stuart Wong, MD

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Withdrawn

  • University of California, San Francisco

    San Francisco, California, 94115

    Imani Dunn, 415-476-7600, imani.dunn@ucsf.edu

    Sue S Yom, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Canada, MSG 1Z5

    Arundhati Shukla, Arundhati.shukla@uhn.ca

    Anna Spreafico, MD, PhD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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).

Keywords
Programmed death 1 [PD1] inhibitor, Toripalimab, Recurrent metastatic nasopharyngeal cancer
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Also called JS001, TAB-001, CHS-007

    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.

  • CisplatinDrug

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

  • GemcitabineDrug

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

  • CarboplatinDrug

    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.

Study groups in NCT06457503
Study groupRoleWhat they receive
Toripalimab + cisplatin (or carboplatin) + gemcitabineExperimentalParticipants 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.
Receives: Drug: Toripalimab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 24 months

Secondary outcomes (9)

  1. Duration of Response (DoR) assessed by BICR according to RECIST v1.1

    Measured: Up to 24 months

  2. ORR assessed by the investigator according to RECIST v1.1

    Measured: Up to 24 months

  3. DoR assessed by the investigator according to RECIST v1.1

    Measured: Up to 24 months

  4. Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1

    Measured: Up to 24 months

  5. PFS assessed by the investigator according to RECIST v1.1

    Measured: Up to 24 months

  6. Overall Survival (OS) defined as time from enrollment to death due to any cause

    Measured: Up to 42 months

  7. Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1

    Measured: Up to 24 months

  8. DCR assessed by the investigator according to RECIST v1.1

    Measured: Up to 24 months

  9. Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve

    Measured: 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start1 Nov 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457503
Sponsor's protocol ID
CHS-007-01/RTOG 3521
Acronym
TRANSPARENT
Status last verified
Jul 2026
First submitted
10 Jun 2024
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Toripalimab, Cisplatin and Gemcitabine in people with Nasopharyngeal Cancer Recurrent, run by Coherus Oncology, Inc. at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Operations Team Clinical Operations (800-794-5434, clinicaltrials@coherus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457503.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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