IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
November 14, 2024 updated by: Innovent Biologics (Suzhou) Co. Ltd.
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Beijing Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IBI310 + Sintilimab
|
Specified dose on specified days
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ORR
Time Frame: Up to 3 years
|
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival
Time Frame: Up to 3 years
|
Up to 3 years
|
|
ORR in all MSI-H CRC patients based on investigator assessment.
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Progression-Free Survival (PFS) both by investigator and IRC
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Disease Control Rate (DCR) both by investigator and IRC
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Duration of Response (DoR) both by investigator and IRC
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Time To Response (TTR) both by investigator and IRC
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Incidence of adverse events (AE)
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2020
Primary Completion (Actual)
October 26, 2020
Study Completion (Actual)
October 26, 2020
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 5, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Estimated)
November 18, 2024
Last Update Submitted That Met QC Criteria
November 14, 2024
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Genomic Instability
- Colorectal Neoplasms
- Microsatellite Instability
- Immunologic Factors
- Physiological Effects of Drugs
- Antibodies
- Immunoglobulins
Other Study ID Numbers
- CIBI310D201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.