---
title: A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer
nct_id: NCT06457503
overall_status: RECRUITING
phase: PHASE4
sponsor: Coherus Oncology, Inc.
study_type: INTERVENTIONAL
primary_condition: Nasopharyngeal Cancer Recurrent
countries: United States, Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06457503.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06457503"
ct_last_update_post_date: 2026-04-06
last_seen_at: "2026-05-12T07:02:26.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer

**Official Title:** Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

**NCT ID:** [NCT06457503](https://clinicaltrials.gov/study/NCT06457503)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Coherus Oncology, Inc.
- **Conditions:** Nasopharyngeal Cancer Recurrent
- **Start Date:** 2024-11-01
- **Completion Date:** 2027-12
- **CT.gov Last Update:** 2026-04-06

## Brief Summary

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

## 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).

## Eligibility

- **Minimum age:** 12 Years
- **Sex:** ALL
- **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.
```

## Arms

- **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.

## Interventions

- **Toripalimab** (DRUG) — 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** (DRUG) — Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
- **Gemcitabine** (DRUG) — Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
- **Carboplatin** (DRUG) — 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.

## Primary Outcomes

- **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)_

## Secondary Outcomes

- **Duration of Response (DoR) assessed by BICR according to RECIST v1.1** _(time frame: Up to 24 months)_
- **ORR assessed by the investigator according to RECIST v1.1** _(time frame: Up to 24 months)_
- **DoR assessed by the investigator according to RECIST v1.1** _(time frame: Up to 24 months)_
- **Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1** _(time frame: Up to 24 months)_
- **PFS assessed by the investigator according to RECIST v1.1** _(time frame: Up to 24 months)_
- **Overall Survival (OS) defined as time from enrollment to death due to any cause** _(time frame: Up to 42 months)_
- **Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1** _(time frame: Up to 24 months)_
- **DCR assessed by the investigator according to RECIST v1.1** _(time frame: Up to 24 months)_
- **Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve** _(time frame: 12 months, 24 months)_

## Locations (13)

- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States — _RECRUITING_
- University of California, Irvine, Irvine, California, United States — _RECRUITING_
- University of California, San Francisco, San Francisco, California, United States — _RECRUITING_
- Emory Winship Cancer Institute, Atlanta, Georgia, United States — _RECRUITING_
- Boston Medical Center, Boston, Massachusetts, United States — _RECRUITING_
- University of Michigan, Ann Arbor, Michigan, United States — _RECRUITING_
- Henry Ford Cancer Center, Detroit, Michigan, United States — _RECRUITING_
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States — _WITHDRAWN_
- University of Cincinnati Medical Center, Cincinnati, Ohio, United States — _RECRUITING_
- Cleveland Clinic, Cleveland, Ohio, United States — _RECRUITING_
- Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States — _RECRUITING_
- Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States — _RECRUITING_
- Princess Margaret Cancer Centre, Toronto, Canada — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of arkansas for medical sciences|little rock|arkansas|united states` — added _(2026-05-12)_
- `locations.university of california, irvine|irvine|california|united states` — added _(2026-05-12)_
- `locations.university of california, san francisco|san francisco|california|united states` — added _(2026-05-12)_
- `locations.emory winship cancer institute|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.boston medical center|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_
- `locations.henry ford cancer center|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.laura & isaac perlmutter cancer center at nyu langone health|new york|new york|united states` — added _(2026-05-12)_
- `locations.university of cincinnati medical center|cincinnati|ohio|united states` — added _(2026-05-12)_
- `locations.cleveland clinic|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.penn state milton s. hershey medical center|hershey|pennsylvania|united states` — added _(2026-05-12)_
- `locations.froedtert hospital and the medical college of wisconsin|milwaukee|wisconsin|united states` — added _(2026-05-12)_
- `locations.princess margaret cancer centre|toronto||canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06457503.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06457503*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*