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

Overview

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).

Interventions

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

Primary outcome measures

• 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 outcome measures (9)

• 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]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 12 centers

• University of Arkansas for Medical Sciences — Little Rock
• University of California, Irvine — Irvine
• University of California, San Francisco — San Francisco
• Emory Winship Cancer Institute — Atlanta
• Boston Medical Center — Boston
• University of Michigan — Ann Arbor
• Henry Ford Cancer Center — Detroit
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York
• … and 4 more centers

Canada · 1 center

• Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT06457503 · CHS-007-01/RTOG 3521

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗