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NCT Number: NCT03581786

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

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.

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Key information

Conditions

Recurrent or Metastatic NPC Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age ≥ 18 years and ≤75 years.
  • 2. Histological/cytological confirmation of NPC.
  • 3. 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.
  • 4. At least 1 measurable lesion according to RECIST version 1.1.
  • 5. Life expectancy ≥ 3 months

Exclusion criteria

  • 1. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001.
  • 2. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor.
  • 3. 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
  • 4. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients.
  • 5. Female patients who are at pregnancy or lactation.

Treatment and study plan

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Biological

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Placebos

Drug

placebo combine with chemotherapy

Primary outcomes

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

    Time frame: up to 2 years

    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.

Secondary outcomes

  1. OS

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

    Overall survival was defined as the time from randomization to death from any cause.

  2. Investigator-assessed ORR According to RECIST v1.1

    Time frame: 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

    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.

  3. Investigator-assessed DoR According to RECIST v1.1

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

    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.

  4. Investigator-assessed DCR According to RECIST v1.1

    Time frame: 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

    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.

  5. Investigator-assessed PFS According to RECIST v1.1

    Time frame: 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

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

  6. Investigator-assessed PFS Rate at 1 Year

    Time frame: up to approximately 1years

    To evaluate the PFS rate at 1 year in each treatment arm by investigator

  7. OS Rate at 1 Year

    Time frame: Up to approximately 1 years

    To evaluate the OS rate at 1 year in each treatment arm

  8. IRC-assessed ORR According to RECIST v1.1

    Time frame: 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

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

  9. IRC-assessed DoR According to RECIST v1.1

    Time frame: 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

    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.

  10. IRC-assessed DCR According to RECIST v1.1

    Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

    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.

  11. Number of Participants Experiencing an Adverse Event(AE)

    Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

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

  12. Anti-drug Antibody(ADA)

    Time frame: 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

    To evaluate the incidence of ADAs against JS001

  13. PFS IRC-assessed Per irRECIST

    Time frame: 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

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

  14. ORR IRC-assessed Per irRECIST

    Time frame: 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

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

  15. DoR IRC-assessed Per irRECIST

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

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

  16. DCR IRC-assessed Per irRECIST

    Time frame: 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

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

  17. Investigator-assessed PFS Rate at 2 Years

    Time frame: 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

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

  18. OS Rate at 2 Years

    Time frame: Up to approximately 2 years

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

  19. PFS Investigator-assessed Per irRECIST

    Time frame: 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

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

  20. ORR Investigator-assessed Per irRECIST

    Time frame: 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

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

  21. DoR Investigator-assessed Per irRECIST

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

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

  22. DCR Investigator-assessed Per irRECIST

    Time frame: Up to approximately 42 months

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

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jul 10, 2018
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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