Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Recurrence

Nasopharyngeal Carcinoma

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years

Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Placebos

Ruihua Xu, Ph.D

This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.

Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy，as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients.

The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (thisincludes the baseline sum if that is the smallest on study). In addition to the relative increase of20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by overall survival (OS).

an AnticipatedReporting Date of final OS in 2023.

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1

To evaluate the PFS rate at 1 and 2 years in each treatment arm by investigator

To evaluate the OS rate at 1 and 2 years in each treatment arm

health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-C30 \&EORTC QLQ-H\&N35ECOG

health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1.

Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0

To evaluate the incidence and titers of ADAs against JS001 and to explore the potential relationship of the immunogenicity response with pharmacodynamics, safety and efficacy.

To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Shanghai Junshi Bioscience Co., Ltd.

Safety data are based on the 30 May 2020 cut-off date

Placebos: placebo combine with chemotherapy

Placebo Combine With Chemotherapy

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Singapore

China

Taiwan

Region of Enrollment

Xiaojun Wang

IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1

Investigator-assessed ORR According to RECIST v1.1

Investigator-assessed DoR According to RECIST v1.1

Investigator-assessed DCR According to RECIST v1.1

Investigator-assessed PFS According to RECIST v1.1

Investigator-assessed PFS Rate at 1 and 2 Years

OS Rate at 1 and 2 Years

Patient-Reported Outcome (PRO) Using EORTC QLQ-C30, EORTC QLQ-H&N35 and ECOG Performance Status Assessments

IRC-assessed ORR According to RECIST v1.1

IRC-assessed DoR According to RECIST v1.1

IRC-assessed DCR According to RECIST v1.1

Safety Variables Will be Monitored and Reported:AE.SAE.Vital Signs,Physical Examinations,Laboratory Variable,ECG

ADAs

PFS Assessed Per irRECIST

ORR Assessed Per irRECIST

DoR Assessed Per irRECIST

DCR Assessed Per irRECIST

In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles.During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.

In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles .

During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer	NCT03581786	Recurrent or Me...	TORIPALIMAB INJ... Placebos	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer	NCT03581786	Recurrent or Me...	TORIPALIMAB INJ... Placebos	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for toripalimab injection(js001 ) combine with chemotherapy