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

Study Overview
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Brief Summary
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Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

Official Title
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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

Conditions
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MSI-H

Intervention / Treatment
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* Drug: IBI310
* Procedure: Radical surgery
* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ib Experimental group<br> | Drug: IBI310<br>* In arm 1，IBI310 will be used once<br>Procedure: Radical surgery<br>* Radical surgery after neoadjuvant therapy<br>Drug: Sintilimab<br>* In arm1&2，Sintilimab will be used twice ，q3w<br>|
| Active Comparator: Ib Control group<br> | Procedure: Radical surgery<br>* Radical surgery after neoadjuvant therapy<br>Drug: Sintilimab<br>* In arm1&2，Sintilimab will be used twice ，q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Pathological Response, MPR, defined as the proportion of subjects with ≤ 10% residual survivable tumor in the removed primary tumor after neoadjuvant therapy |  | 1 month after surgery | 
| 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 |  | 3 years after surgery | 
| R0 tumor resection rate, defined as the proportion of subjects with R0 excision |  | 1 week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dMMR, resectable colon cancer