Evaluating IBI310 and Sintilimab for treating resectable colon cancer

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

This study is testing a new combination treatment of IBI310 and Sintilimab to see if it helps people with certain types of colon cancer before they have surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Sintilimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05890742 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the efficacy and safety of IBI310, a CTLA-4 antibody, in combination with Sintilimab for the neoadjuvant treatment of patients with MSI-H/dMMR resectable colon cancer. The study aims to determine how well this combination therapy works before radical surgery in patients diagnosed with stage IIB-III colon adenocarcinoma. Participants will be monitored for their response to treatment and any potential side effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed primary colon adenocarcinoma that is MSI-H or dMMR and resectable stage IIB-III.

Not a fit: Patients who have previously received any form of antitumor therapy for their colon cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with MSI-H/dMMR resectable colon cancer by enhancing tumor response prior to surgery.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating MSI-H/dMMR cancers, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jiayu Wen

Conditions MSI-H; dMMR; resectable colon cancer