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

NCT03581786 | Completed Phase 3 Results FDA Drug

• 1 other identifier: JS001-015-III-NPC
• Study Type: interventional
• Target: 289
• Locations: 3 countries
• Sites: 32

Brief Summary

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.

Conditions

Recurrent or Metastatic NPC

Outcome Measures

Primary Outcomes (1)

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

  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 (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, 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.

  up to 2 years

Secondary Outcomes (22)

• OS

  The time frame of OS collected is upto about 48months.

• Investigator-assessed ORR According to RECIST v1.1

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

• Investigator-assessed DoR According to RECIST v1.1

  From date of response until progressive disease. Up to 2 approximately years

• Investigator-assessed DCR According to RECIST v1.1

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

• Investigator-assessed PFS According to RECIST v1.1

  From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

Study Arms (2)

placebo combine with chemotherapy

PLACEBO COMPARATOR

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

Drug: Placebos

TORIPALIMAB INJECTION(JS001 )combine with chemotherapy

EXPERIMENTAL

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

Biological: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Interventions

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy BIOLOGICAL

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

TORIPALIMAB INJECTION(JS001 )combine with chemotherapy

Placebos DRUG

placebo combine with chemotherapy

placebo combine with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years and ≤75 years.
• \. Histological/cytological confirmation of NPC.
• \. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment.
• \. At least 1 measurable lesion according to RECIST version 1.1.
• \. Life expectancy ≥ 3 months

You may not qualify if:

• \. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001.
• \. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor.
• \. Major surgical procedure other than for diagnosis of NPC within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study
• \. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients.
• \. Female patients who are at pregnancy or lactation.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (32)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Liuzhou Worker's Hospital

Liuchow, Guangxi, 545000, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, Guangzhou, 515031, China

Location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangzhou, 130012, China

Location

The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology

Zhuhai, Guangzhou, 519000, China

Location

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

Hainan General Hospital (Hainan Province People's Hospital)

Haikou, Hainan, 570311, China

Location

Hebei Oncology Hospital

Shijiazhuang, Hebei, 50011, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430023, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital

Wuhan, Hubei, 430030, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangsu Oncology Hospital

Nanjing, Jiangsu, 210000, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

TaiChung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

• Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.

  PMID: 38015220 DERIVED

• Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. doi: 10.1038/s41591-021-01444-0. Epub 2021 Aug 2.

  PMID: 34341578 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Xiaojun Wang
• Organization: Shanghai Junshi Bioscience Co., Ltd.

xiaojun_wang@junshipharma.com

86-021-50796193

Study Officials

• Ruihua Xu, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 10, 2018
• Study Start: October 18, 2018
• Primary Completion: May 30, 2020
• Study Completion: November 18, 2022
• Last Updated: September 2, 2025
• Results First Posted: April 18, 2022

Record last verified: 2024-08

Locations

SG (2); TW (5); CN (25)