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Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma (ORIENT-15)

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ClinicalTrials.gov Identifier: NCT03748134
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE December 13, 2018
Estimated Primary Completion Date July 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • OS in overall population [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]
    To compare the overall survival of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
  • OS in PD-L1 positive population [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]
    To compare the OS of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with PD-L1 positive, unresectable, locally advanced, recurrent or metastatic ESCC
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2018)
  • OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]
    Overall Survival
  • OS in PD-L1 positive population [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]
    Overall Survival in PD-L1 positive population
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • ORR in overall population [ Time Frame: From date of randomization up to 28 months. ]
    To compare the objective response rate between the two treatment arms in ITT population
  • PFS in overall populationsubjects in ITT population [ Time Frame: From date of randomization up to 28 months ]
    To compare the progression-free survival between the two treatment arms in ITT population
  • DCR in overall population [ Time Frame: From date of randomization up to 28 months ]
    To compare the disease control rate between the two treatment arms in ITT population
  • DoR in overall population [ Time Frame: From date of randomization up to 28 months ]
    To compare the duration of response between the two treatment arms in ITT population
  • ORR - PD-L1 positive [ Time Frame: From date of randomization up to 28 months ]
    To compare the objective response rate between the two treatment arms in PD-L1 positive subjects in ITT population
  • DCR - PD-L1 positive [ Time Frame: From date of randomization up to 28 months ]
    To compare the disease control rate between the two treatment arms in PD-L1 positive subjects in ITT population
  • DoR - PD-L1 positive [ Time Frame: From date of randomization up to 28 months ]
    To compare the duration of response between the two treatment arms in PD-L1 positive subjects in ITT population
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2018)
PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 28 months. ]
Progression Free Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma
Official Title  ICMJE A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)
Brief Summary This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE
  • Biological: Sintilimab
    For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
  • Drug: Placebo
    For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
  • Drug: Cisplatin
    75mg/m^2 IV Q3W day 1
  • Drug: Paclitaxel
    87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle
  • Drug: Fluorouracil
    800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
Study Arms  ICMJE
  • Experimental: Sintilimab + chemotherapy

    Sintilimab in combination with investigator's choice of chemotherapy

    TP regimen: Cisplatin + paclitaxel

    or

    CP regimen: Cisplatin + fluorourcil

    Interventions:
    • Biological: Sintilimab
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Fluorouracil
  • Active Comparator: Placebo + chemotherapy

    Placebo in combination with investigator's choice of chemotherapy

    TP regimen: Cisplatin + paclitaxel

    or

    CP regimen: Cisplatin + fluorourcil

    Interventions:
    • Drug: Placebo
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Fluorouracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
676
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2018)
640
Estimated Study Completion Date  ICMJE July 30, 2022
Estimated Primary Completion Date July 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic ESCC (excluding mixed adenosquamous carcinoma and other histological subtypes)
  • ECOG PS of 0 or 1
  • Subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or definitive chemotherapy/radiochemotherapy, time from the completion of last treatment to disease recurrence must be > 6 months Could provide archival or fresh tissues for PD-L1 expression analysis with obtainable results#
  • Have at least one measurable lesion as per RECIST v1.1

Key exclusion Criteria:

  • ESCC with endoscopy-confirmed near-complete obstruction requiring interventional therapy
  • Post stent implantation in the esophagus or trachea with risk of perforation
  • Received systemic treatment for advanced or metastatic ESCC.
  • Received a Cumulative dose of cisplatin > 300 mg/m2 within 12 months to randomization.
  • High risk of hemorrhage or perforations due to tumor invasion in adjacent organs (aorta or trachea), or have fistula formation.
  • Hepatic metastasis > 50% of the total liver volume.
  • Received palliative therapy for a local lesion within 2 weeks prior to the first dose.
  • Received systemic treatment with Chinese traditional medicines with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment.
  • Received systemic immunosuppressants within 2 weeks prior to randomization, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Agnes Sun +86 21 31820291 xiaolei.sun@innoventbio.com
Contact: Peter Pan +86 21 31655781 xinchun.pan@innoventbio.com
Listed Location Countries  ICMJE Australia,   Belgium,   China,   France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03748134
Other Study ID Numbers  ICMJE CIBI308A301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innovent Biologics (Suzhou) Co. Ltd.
Study Sponsor  ICMJE Innovent Biologics (Suzhou) Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innovent Biologics (Suzhou) Co. Ltd.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP