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

Innovent Biologics

Status and phase: Enrolling; Phase 3

Conditions: MSI-H

Treatments: Drug: Sintilimab; Procedure: Radical surgery; Drug: IBI310&Sintilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05890742

CIBI310L301

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
2. At least 18 years old.
3. Primary colon adenocarcinoma was histologically confirmed.
4. Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
5. MSI-H or dMMR.
6. Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
7. Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
8. The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.

Exclusion criteria

1. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
2. 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.
3. 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.
4. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 4 patient groups

Phase Ib Experimental group

Experimental group

Description:

In Phase Ib Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) \& Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer.

Treatment:

Procedure: Radical surgery

Drug: IBI310&Sintilimab

Phase Ib Control group

Active Comparator group

Description:

In Phase Ib Control group，subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer.

Treatment:

Procedure: Radical surgery

Drug: Sintilimab

Phase III Experimental group

Experimental group

Description:

In Phase III Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) \& Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only. Followed by radical surgery for colon cancer. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery.

Treatment:

Drug: IBI310&Sintilimab

Phase III Control group

Active Comparator group

Description:

In Phase III Control group, subjects will receive radical surgery without neoadjuvant therapy. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery.

Treatment:

Procedure: Radical surgery