Clinical trial NCT06457503: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nasopharyngeal Cancer Recurrent
Keywords: Programmed death 1 [PD1] inhibitor
Toripalimab
Recurrent metastatic nasopharyngeal cancer
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 months
Secondary outcomes:
measure: Duration of Response (DoR) assessed by BICR according to RECIST v1.1
timeFrame: Up to 24 months
measure: ORR assessed by the investigator according to RECIST v1.1
timeFrame: Up to 24 months
measure: DoR assessed by the investigator according to RECIST v1.1
timeFrame: Up to 24 months
measure: Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1
timeFrame: Up to 24 months
measure: PFS assessed by the investigator according to RECIST v1.1
timeFrame: Up to 24 months
measure: Overall Survival (OS) defined as time from enrollment to death due to any cause
timeFrame: Up to 42 months
measure: Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1
timeFrame: Up to 24 months
measure: DCR assessed by the investigator according to RECIST v1.1
timeFrame: Up to 24 months
measure: Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
Study officials:
References: