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NCT06457503PHASE4Recruiting

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

Coherus Oncology, Inc.

Start Date

11/1/2024

Completion Date

12/1/2027

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 Criteria

Age Range: 12 years to No maximum

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.

Interventions

DRUG

Toripalimab

DRUG

Cisplatin

DRUG

Gemcitabine

DRUG

Carboplatin

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Conditions

Nasopharyngeal Cancer Recurrent

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

University of California, Irvine

Irvine, California 92697

United States

University of California, San Francisco

San Francisco, California 94115

United States

Emory Winship Cancer Institute

Atlanta, Georgia 30322

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Cancer Center

Detroit, Michigan 48202

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York 10016

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Princess Margaret Cancer Centre

Toronto, Canada MSG 1Z5

Canada