Back to resultsIBI310 in Combination With Sintilimab in Patients With DNA Mismatch Repair Deficient (dMMR)/Microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IBI310 (anti-CTLA-4 antibody)
Sintilimab(anti-PD-1 antibody)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed colorectal adenocarcinoma
- Imaging confirmed locally-advanced or metastatic colorectal cancer
- Measurable disease by CT or MRI
- MSI-H confirmed by central lab
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria:
- Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Subjects with active,known or suspected autoimmune disease
- Subjects with a history of primary immune deficiency
- Subjects with severe infectious diseases
Sites / Locations
- Beijing cancer hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBI310 + Sintilimab
Arm Description
Outcomes
Primary Outcome Measures
ORR
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
Secondary Outcome Measures
ORR in all MSI-H CRC patients based on investigator assessment.
Progression-Free Survival (PFS) both by investigator and IRC
Disease Control Rate (DCR) both by investigator and IRC
Duration of Response (DoR) both by investigator and IRC
Time To Response (TTR) both by investigator and IRC
Overall Survival
Incidence of adverse events (AE)
Full Information
NCT ID
NCT04258111
First Posted
February 4, 2020
Last Updated
September 15, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04258111
Brief Title
IBI310 in Combination With Sintilimab in Patients With DNA Mismatch Repair Deficient (dMMR)/Microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
Official Title
An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination With Sintilimab in Patients With DNA Mismatch Repair Deficient (dMMR) /Microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
May 2023 (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
The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI310 + Sintilimab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
IBI310 (anti-CTLA-4 antibody)
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Sintilimab(anti-PD-1 antibody)
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
ORR in all MSI-H CRC patients based on investigator assessment.
Time Frame
Up to 3 years
Title
Progression-Free Survival (PFS) both by investigator and IRC
Time Frame
Up to 3 years
Title
Disease Control Rate (DCR) both by investigator and IRC
Time Frame
Up to 3 years
Title
Duration of Response (DoR) both by investigator and IRC
Time Frame
Up to 3 years
Title
Time To Response (TTR) both by investigator and IRC
Time Frame
Up to 3 years
Title
Overall Survival
Time Frame
Up to 3 years
Title
Incidence of adverse events (AE)
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed colorectal adenocarcinoma
Imaging confirmed locally-advanced or metastatic colorectal cancer
Measurable disease by CT or MRI
MSI-H confirmed by central lab
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria:
Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Subjects with active,known or suspected autoimmune disease
Subjects with a history of primary immune deficiency
Subjects with severe infectious diseases
Facility Information:
Facility Name
Beijing cancer hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
IBI310 in Combination With Sintilimab in Patients With DNA Mismatch Repair Deficient (dMMR)/Microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
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