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Sintilimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (ORIENT-15)

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ClinicalTrials.gov Identifier: NCT03748134
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Biological: Sintilimab Drug: Paclitaxel Drug: Cisplatin Biological: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With Paclitaxel and Cisplatin as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma: a Randomized, Double-blind, Multicenter, Phase 3 Study (ORIENT-15)
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sintilimab+Chemo

Sintilimab: for weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1.

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.

Cisplatin: 75mg/m^2 IV Q3W day 1.

 Biological: Sintilimab
For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg 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: Cisplatin
75mg/m^2 IV Q3W day 1
Placebo Comparator: Placebo+Chemo

Placebo: for weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1.

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.

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: Cisplatin
75mg/m^2 IV Q3W day 1

Biological: Placebo
For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1


Outcome Measures
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Primary Outcome Measures :
  1. OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 40 months. ]
    Overall Survival

  2. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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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. Histopathological confirmed esophageal squamous carcinoma.
  2. 18≤age≤75
  3. ECOG PS is 0-1.
  4. Subject not suitable for radical therapy, such as chemoradiotherapy or surgery.
  5. Time from last dose of prior chemotherapy/radiotherapy/surgery to recurrent disease＞6 months.
  6. Can provide archived tissue or fresh tissue for PD-L1 expression measurement.
  7. At least one measurable lesion per RECIST v1.1.
  8. Adequate organ function.

Exclusion Criteria:

  1. Prior systemic treatment for esophageal squamous carcinoma.
  2. Previously treated with PD-1, PD-L1,PD-L2, CD137, or CTLA-4 antibodies.
  3. Known active tuberculosis
  4. History of allogeneic organ or allogeneic hemopoietic stem cell transplantation
  5. Other primary malignancy.
Contacts and Locations
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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): NCT03748134


Contacts
Contact: Agnes Sun +86 21 31820291 xiaolei.sun@innoventbio.com
Contact: Peter Pan +86 21 31655781 xinchun.pan@innoventbio.com

Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03748134     History of Changes
Other Study ID Numbers: CIBI308A301
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action