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Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer

Primary Purpose

Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Sintilimab
IBI310
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ malignant tumor (including squamous carcinoma, adenocarcinoma, Signet-ring cell carcinoma).
  • Confirmed EBV positive determined by in situ hybridization (ISH), analyzed with tumor tissue sample, either from a previous surgery or biopsy , within last 6 months
  • Male or Female at least 18 years of age
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Has adequate organ function.
  • Expected survival>=12 weeks
  • Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment.
  • Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication.

Applied to Arms 1: Has histologically confirmed gastric/GEJ malignant tumor, and were regarded as having clinical stage T3-T4aN0M0 or T2～4aN+M0

Applied to Arms 2: Had no prior systemic treatment for metastatic disease.

Applied to Arms 3: Received ≥1 prior systemic treatment for metastatic disease.

Exclusion Criteria:

  • Has received prior therapy with an anti-programmed death (PD)-1, antiPD-L1, anti-PD L2, anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  • Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
  • Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Neoadjuvant therapy group

first-line therapy group

≥second-line therapy group

Arm Description

Outcomes

Primary Outcome Measures

Arms 1: Neoadjuvant therapy group
Pathological complete regression (pCR): Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist
Arms 2: first-line therapy group
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Arms 3:≥second-line therapy group
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.

Secondary Outcome Measures

Arms 1: Neoadjuvant therapy group
R0 resection rate
Arms 1: Neoadjuvant therapy group
Event free survival(EFS)
Arms 1: Neoadjuvant therapy group
Objective response rate(ORR)
Arms 1: Neoadjuvant therapy group
Disease control rate(DCR)
Arms 1: Neoadjuvant therapy group
Overall survival(OS)
Arms 1: Neoadjuvant therapy group
Number of participants experiencing clinical and laboratory adverse events (AEs).
Arms 2: first-line therapy group
Progression-free survival (PFS）
Arms 2: first-line therapy group
Disease control rate (DCR）
Arms 2: first-line therapy group
Overall survival (OS）
Arms 2: first-line therapy group
( Number of participants experiencing clinical and laboratory adverse events (AEs).
Arms 3:≥second-line therapy group
Progression-free survival (PFS）
Arms 3:≥second-line therapy group
Disease control rate (DCR)
Arms 3:≥second-line therapy group
Overall survival (OS）
Arms 3:≥second-line therapy group
Number of participants experiencing clinical and laboratory adverse events (AEs)

Full Information

First Posted
December 12, 2019
Last Updated
December 17, 2019
Sponsor
Peking University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04202601
Brief Title
Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer
Official Title
Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2019 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant therapy group
Arm Type
Experimental
Arm Title
first-line therapy group
Arm Type
Experimental
Arm Title
≥second-line therapy group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
Arms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
Intervention Type
Drug
Intervention Name(s)
IBI310
Intervention Description
Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
Primary Outcome Measure Information:
Title
Arms 1: Neoadjuvant therapy group
Description
Pathological complete regression (pCR): Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 2: first-line therapy group
Description
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 3:≥second-line therapy group
Description
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Time Frame
Approximately 40 months after the first participant is randomized
Secondary Outcome Measure Information:
Title
Arms 1: Neoadjuvant therapy group
Description
R0 resection rate
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 1: Neoadjuvant therapy group
Description
Event free survival(EFS)
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 1: Neoadjuvant therapy group
Description
Objective response rate(ORR)
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 1: Neoadjuvant therapy group
Description
Disease control rate(DCR)
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 1: Neoadjuvant therapy group
Description
Overall survival(OS)
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 1: Neoadjuvant therapy group
Description
Number of participants experiencing clinical and laboratory adverse events (AEs).
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 2: first-line therapy group
Description
Progression-free survival (PFS）
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 2: first-line therapy group
Description
Disease control rate (DCR）
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 2: first-line therapy group
Description
Overall survival (OS）
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 2: first-line therapy group
Description
( Number of participants experiencing clinical and laboratory adverse events (AEs).
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 3:≥second-line therapy group
Description
Progression-free survival (PFS）
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 3:≥second-line therapy group
Description
Disease control rate (DCR)
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 3:≥second-line therapy group
Description
Overall survival (OS）
Time Frame
Approximately 40 months after the first participant is randomized
Title
Arms 3:≥second-line therapy group
Description
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame
Approximately 40 months after the first participant is randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ malignant tumor (including squamous carcinoma, adenocarcinoma, Signet-ring cell carcinoma). Confirmed EBV positive determined by in situ hybridization (ISH), analyzed with tumor tissue sample, either from a previous surgery or biopsy , within last 6 months Male or Female at least 18 years of age Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Has adequate organ function. Expected survival>=12 weeks Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication. Applied to Arms 1: Has histologically confirmed gastric/GEJ malignant tumor, and were regarded as having clinical stage T3-T4aN0M0 or T2～4aN+M0 Applied to Arms 2: Had no prior systemic treatment for metastatic disease. Applied to Arms 3: Received ≥1 prior systemic treatment for metastatic disease. Exclusion Criteria: Has received prior therapy with an anti-programmed death (PD)-1, antiPD-L1, anti-PD L2, anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study . Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease. Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period. Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, professor
Phone
86-10-88196561
Email
linshenpku@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Peng, Associate Professor
Phone
86-10-88196561
Email
zhipeng3@hotmail.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Lin, Professor
Phone
010-88196561
Email
Linshenpku@163.com
First Name & Middle Initial & Last Name & Degree
Shen Lin, professor

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer

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