ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase III Study of Comparing JS001 Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03581786
Recruitment Status : Not yet recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co.,Ltd.

Brief Summary:
This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of 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.

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic NPC Biological: JS001 Drug: Placebos Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III ,Randomized,Placebo-Conrolled,Muticenter,Double-Blind Study Comparing JS001 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : August 21, 2020

Arm Intervention/treatment
Placebo Comparator: placebo combine with chemotherapy Drug: Placebos
placebo combine with chemotherapy

Experimental: JS001 combine with chemotherapy Biological: JS001
JS001 combine with chemotherapy




Primary Outcome Measures :
  1. PFS [ Time Frame: up to 2 years ]
    To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy,as measured by investigator-assessed progression free survival (PFS) according to RECIST v1.1 in all patients.


Secondary Outcome Measures :
  1. OS [ Time Frame: up to 5 years ]
    To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by overall survival (OS).

  2. ORR [ 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 investigator-assessed overall response rate (ORR) according to RECIST v1.1.

  3. DOR [ Time Frame: From date of response until progressive disease. Up to 2 approximately years ]
    To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.

  4. DCR [ 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 investigator-assessed disease control rate (DCR) according to RECIST v1.1.

  5. iDMC-assessed PFS [ 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 an independent monitoring committee (iDMC)-assessed PFS according to RECIST v1.1

  6. PFS rate [ 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 1 and 2 years in each treatment arm

  7. OS rate [ Time Frame: From date of randomization until death, loss to follow-up, or study termination by the Sponsor whichever occurs first.Up to 3.5 approximately years ]
    To evaluate the OS rate at 1 and 2 years in each treatment arm

  8. Patient-Reported Outcomes collected via the EORTC QLQ-C30 [ 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-C30

  9. Patient-Reported Outcomes collected via the EORTC QLQ-H&N35 [ 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

  10. health related quality of life using ECOG performance status [ 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 ECOG performance status assessments

  11. Incidence and severity of adverse events as assessed by CTCAE version 5.0 [ Time Frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years ]
    Incidence and severity of adverse events as assessed by CTCAE version 5.0

  12. Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0 [ Time Frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years ]
    Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0

  13. ADAs [ 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 and titers of ADAs against JS001 and to explore the potential relationship of the immunogenicity response with pharmacodynamics, safety and efficacy.

  14. PFS 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.

  15. ORR 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.

  16. DoR 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.

  17. DCR 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581786


Contacts
Contact: Wang Xiaojun +86 18224042444 xiaojun_wang@topalliancebio.com

  Show 34 Study Locations
Sponsors and Collaborators
Shanghai Junshi Bioscience Co.,Ltd.

Responsible Party: Shanghai Junshi Bioscience Co.,Ltd.
ClinicalTrials.gov Identifier: NCT03581786     History of Changes
Other Study ID Numbers: JS001-015-III-NPC
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No