Study Stopped
After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer
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
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 colorectal-cancer
Started Aug 2020
Shorter than P25 for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2020
CompletedNovember 18, 2024
September 1, 2022
2 months
February 4, 2020
November 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee
Up to 3 years
Secondary Outcomes (7)
ORR in all MSI-H CRC patients based on investigator assessment.
Up to 3 years
Progression-Free Survival (PFS) both by investigator and IRC
Up to 3 years
Disease Control Rate (DCR) both by investigator and IRC
Up to 3 years
Duration of Response (DoR) both by investigator and IRC
Up to 3 years
Time To Response (TTR) both by investigator and IRC
Up to 3 years
- +2 more secondary outcomes
Study Arms (1)
IBI310 + Sintilimab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing cancer hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2020
First Posted
February 6, 2020
Study Start
August 27, 2020
Primary Completion
October 26, 2020
Study Completion
October 26, 2020
Last Updated
November 18, 2024
Record last verified: 2022-09