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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: Up to 24 months]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• 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
• … и ещё 4 центра

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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