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.
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
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.
13 sites in 2 countries
United States12 sites, 11 recruiting
- 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
- Withdrawn
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
- Recruiting
University of California, San Francisco
San Francisco, California, 94115
Imani Dunn, 415-476-7600, imani.dunn@ucsf.edu
Sue S Yom, MD
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Canada, MSG 1Z5
Arundhati Shukla, Arundhati.shukla@uhn.ca
Anna Spreafico, MD, PhD
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).
- Conditions
- Nasopharyngeal Cancer Recurrent
- Being tested
- Toripalimab, Cisplatin, Gemcitabine, Carboplatin
- 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 group | Role | What they receive |
|---|---|---|
| Toripalimab + cisplatin (or carboplatin) + gemcitabine | Experimental | 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. 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.
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)
Duration of Response (DoR) assessed by BICR according to RECIST v1.1
Measured: Up to 24 months
ORR assessed by the investigator according to RECIST v1.1
Measured: Up to 24 months
DoR assessed by the investigator according to RECIST v1.1
Measured: Up to 24 months
Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1
Measured: Up to 24 months
PFS assessed by the investigator according to RECIST v1.1
Measured: Up to 24 months
Overall Survival (OS) defined as time from enrollment to death due to any cause
Measured: Up to 42 months
Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1
Measured: Up to 24 months
DCR assessed by the investigator according to RECIST v1.1
Measured: Up to 24 months
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.
- First posted13 Jun 2024
- Study start1 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Coherus Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Coherus Oncology
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