Toripalimab plus chemotherapy as first-line treatment for recurrent and/or metastatic nasopharyngeal cancer: safety and activity in non-endemic population

Conditions

Recurrent Metastatic Nasopharingeal Carcinoma

Brief summary

Incidence of high-grade (CTCAE v 5.0 grade 3 or higher), treatment related adverse events

Detailed description

Incidence of all high-grade (Grades 3-5), selected adverse events, independently from the association with the study drugs;, Median time to onset and median time to resolution (Grades 3-4) of selected adverse events (resolution of an AE is a subject experiencing complete resolution or improvement to the baseline grade for the AE);, Safety and tolerability measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity., Investigator-assessed Progression Free Survival (PFS) defined as radiological evidence of progression, significant clinical symptomatic progression, the need to introduce a non-study drug therapy or death from any cause., Overall Survival defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive.

Related papers

No related papers found yet.

Interventions

DRUGGemcitabina Hikma 1 g polvere per soluzione per infusione

DRUGCisplatino Hikma 1mg/ml concentrato per soluzione per infusione

DRUGLOQTORZI 240 mg concentrate for solution for infusion

DRUGGemcitabina Hikma 200 mg polvere per soluzione per infusione

DRUGGEMSOL

DRUGGemcitabina Hikma 2g polvere per soluzione per infusione

DRUGCISPLATINO Pfizer 50 mg/50 ml soluzione per infusione

DRUGCISPLATINO SANDOZ

DRUGGemcitabina Aurobindo Pharma Italia 40 mg/ml concentrato per soluzione per infusione

DRUGCisplatino Accord Healthcare Italia 1 mg/ml concentrato per soluzione per infusione

DRUGCisplatino Teva Italia 1 mg/ml concentrato per soluzione per infusione

DRUGGemcitabina Accord 100 mg/ml concentrato per soluzione per infusione.

DRUGGemcitabina SUN 1 g polvere per soluzione per infusione

DRUGSolgekma 38mg/ml concentrato per soluzione per infusione

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of high-grade (CTCAE v 5.0 grade 3 or higher), treatment related adverse events	—

Secondary

Measure	Time frame
Incidence of all high-grade (Grades 3-5), selected adverse events, independently from the association with the study drugs;, Median time to onset and median time to resolution (Grades 3-4) of selected adverse events (resolution of an AE is a subject experiencing complete resolution or improvement to the baseline grade for the AE);, Safety and tolerability measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity., Investigator-assessed Progression Free Survival (PFS) defined as radiological evidence of progression, significant clinical symptomatic progression, the need to introduce a non-study drug therapy or death from any cause., Overall Survival defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive.	—

Measure

Time frame

Incidence of all high-grade (Grades 3-5), selected adverse events, independently from the association with the study drugs;, Median time to onset and median time to resolution (Grades 3-4) of selected adverse events (resolution of an AE is a subject experiencing complete resolution or improvement to the baseline grade for the AE);, Safety and tolerability measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusion-related, or hypersensitivity., Investigator-assessed Progression Free Survival (PFS) defined as radiological evidence of progression, significant clinical symptomatic progression, the need to introduce a non-study drug therapy or death from any cause., Overall Survival defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive.

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Countries

Italy

Outcome results

None listed