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

Nasopharyngeal Cancer Recurrent Clinical Trial

— TRANSPARENT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457503
• Other study ID #: CHS-007-01/RTOG 3521
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Coherus Biosciences, Inc.
• Contact: Sandy Paige, Director, Clinical Operations
• Phone: 800-794-5434
• Email: spaige[@]coherus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Cancer Recurrent
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coherus Biosciences, Inc.

Outcome

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