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NCT03581786 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2025-09-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

OS

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outcome · POSTED

Investigator-assessed ORR According to RECIST v1.1

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outcome · POSTED

Investigator-assessed DoR According to RECIST v1.1

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outcome · POSTED

Investigator-assessed DCR According to RECIST v1.1

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outcome · POSTED

Investigator-assessed PFS According to RECIST v1.1

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outcome · POSTED

Investigator-assessed PFS Rate at 1 Year

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outcome · POSTED

OS Rate at 1 Year

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outcome · POSTED

IRC-assessed ORR According to RECIST v1.1

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outcome · POSTED

IRC-assessed DoR According to RECIST v1.1

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outcome · POSTED

IRC-assessed DCR According to RECIST v1.1

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outcome · POSTED

Number of Participants Experiencing an Adverse Event(AE)

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outcome · POSTED

Anti-drug Antibody(ADA)

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outcome · POSTED

PFS IRC-assessed Per irRECIST

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outcome · POSTED

ORR IRC-assessed Per irRECIST

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outcome · POSTED

DoR IRC-assessed Per irRECIST

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outcome · POSTED

DCR IRC-assessed Per irRECIST

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outcome · POSTED

Investigator-assessed PFS Rate at 2 Years

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outcome · POSTED

OS Rate at 2 Years

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outcome · POSTED

PFS Investigator-assessed Per irRECIST

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outcome · POSTED

ORR Investigator-assessed Per irRECIST

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outcome · POSTED

DoR Investigator-assessed Per irRECIST

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outcome · POSTED

DCR Investigator-assessed Per irRECIST

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Drug: Placebos
    label
    placebo combine with chemotherapy
    type
    PLACEBO_COMPARATOR
  2. description
    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
    intervention Names
    1. Biological: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
    label
    TORIPALIMAB INJECTION(JS001 )combine with chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. TORIPALIMAB INJECTION(JS001 )combine with chemotherapy
    description
    TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
    name
    TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
    type
    BIOLOGICAL
  2. arm Group Labels
    1. placebo combine with chemotherapy
    description
    placebo combine with chemotherapy
    name
    Placebos
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
289
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
    time Frame
    up to 2 years
secondary Outcomes
  1. description
    Overall survival was defined as the time from randomization to death from any cause.
    measure
    OS
    time Frame
    The time frame of OS collected is upto about 48months.
  2. description
    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.
    measure
    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
  3. description
    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.
    measure
    Investigator-assessed DoR According to RECIST v1.1
    time Frame
    From date of response until progressive disease. Up to 2 approximately years
  4. description
    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.
    measure
    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
  5. description
    To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
    measure
    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
  6. description
    To evaluate the PFS rate at 1 year in each treatment arm by investigator
    measure
    Investigator-assessed PFS Rate at 1 Year
    time Frame
    up to approximately 1years
  7. description
    To evaluate the OS rate at 1 year in each treatment arm
    measure
    OS Rate at 1 Year
    time Frame
    Up to approximately 1 years
  8. description
    health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35
    measure
    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
  9. description
    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.
    measure
    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
  10. description
    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.
    measure
    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
  11. description
    Incidence of adverse events(AE) as assessed by CTCAE version 5.0
    measure
    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
  12. description
    To evaluate the incidence of ADAs against JS001
    measure
    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
Full study description
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.
detailed Description
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).
Source references
references
  1. citation
    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
    type
    DERIVED
  2. citation
    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
    type
    DERIVED
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        ent, Locally Advanced NPC with Cisplatin and Gemcitabine The efficacy of LOQTORZI in combination with cisplatin and gemcitabine was investigated in JUPITER-02 (NCT03581786), a randomized, multicenter, single region, double-blind, placebo-controlled trial in 289 patients with metastatic or recurrent, locally advanced NPC who had n
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    Preserved source evidence · Not medical advice