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A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

Primary Purpose

MSI-H

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI310
Radical surgery
Sintilimab
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MSI-H focused on measuring dMMR, resectable colon cancer

Eligibility Criteria

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

Inclusion Criteria: Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan; At least 18 years old. Primary colon adenocarcinoma was histologically confirmed. Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only). MSI-H or dMMR. Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator. Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria. The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1. Exclusion Criteria: Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy. Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ib Experimental group

Ib Control group

Arm Description

Outcomes

Primary Outcome Measures

Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.

Secondary Outcome Measures

Major Pathological Response, MPR, defined as the proportion of subjects with ≤ 10% residual survivable tumor in the removed primary tumor after neoadjuvant therapy
Event Free Survival, EFS, defined as the time from randomization until first determined by RECIST v1.1 to be inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first
R0 tumor resection rate, defined as the proportion of subjects with R0 excision

Full Information

First Posted
May 26, 2023
Last Updated
August 3, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05890742
Brief Title
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
Official Title
A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
April 15, 2028 (Anticipated)
Study Completion Date
July 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MSI-H
Keywords
dMMR, resectable colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ib Experimental group
Arm Type
Experimental
Arm Title
Ib Control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IBI310
Intervention Description
In arm 1,IBI310 will be used once
Intervention Type
Procedure
Intervention Name(s)
Radical surgery
Intervention Description
Radical surgery after neoadjuvant therapy
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
In arm1&2,Sintilimab will be used twice ,q3w
Primary Outcome Measure Information:
Title
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
Major Pathological Response, MPR, defined as the proportion of subjects with ≤ 10% residual survivable tumor in the removed primary tumor after neoadjuvant therapy
Time Frame
1 month after surgery
Title
Event Free Survival, EFS, defined as the time from randomization until first determined by RECIST v1.1 to be inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first
Time Frame
3 years after surgery
Title
R0 tumor resection rate, defined as the proportion of subjects with R0 excision
Time Frame
1 week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan; At least 18 years old. Primary colon adenocarcinoma was histologically confirmed. Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only). MSI-H or dMMR. Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator. Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria. The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1. Exclusion Criteria: Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy. Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayu Wen
Phone
+86-18114928232
Email
jiayu.wen@innovnentbio.com
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu
Phone
+86-20-87343533
Email
xurh@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

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