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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: IBI310 (anti-CTLA-4 antibody)
* Biological: Sintilimab(anti-PD-1 antibody)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI310 + Sintilimab<br> | Biological: IBI310 (anti-CTLA-4 antibody)<br>* Specified dose on specified days<br>Biological: Sintilimab(anti-PD-1 antibody)<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall Survival |  | Up to 3 years | 
| Incidence of adverse events (AE) |  | Up to 3 years |