A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR 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
Innovent Biologics (Suzhou) Co. Ltd.
360 participants
May 25, 2023
INTERVENTIONAL
Conditions
Summary
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Eligibility
Inclusion Criteria8
- 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 Criteria4
- 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.
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Interventions
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
In ARM Phase Ib\&III Experimental group，IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
In ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05890742