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.
Study summary
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 — Up to 24 months
Trial sites (13)
Facility
City
Region
Status
University of Arkansas for Medical Sciences
Little Rock
Arkansas
Recruiting
University of California, Irvine
Irvine
California
Recruiting
University of California, San Francisco
San Francisco
California
Recruiting
Emory Winship Cancer Institute
Atlanta
Georgia
Recruiting
Boston Medical Center
Boston
Massachusetts
Recruiting
University of Michigan
Ann Arbor
Michigan
Recruiting
Henry Ford Cancer Center
Detroit
Michigan
Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York
New York
Withdrawn
University of Cincinnati Medical Center
Cincinnati
Ohio
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Penn State Milton S. Hershey Medical Center
Hershey
Pennsylvania
Recruiting
Froedtert Hospital and the Medical College of Wisconsin
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.