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

NCT05890742 | Recruiting Phase 3

• 1 other identifier: CIBI310L301
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

MSI-H

Keywords

dMMR; resectable colon cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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

• Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.

  The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.

  up to 5 years after surgery

Secondary Outcomes (2)

• R0 tumor resection rate, defined as the proportion of subjects with R0 excision

  2 week after surgery

• Overall-survival(OS), defined as the time from randomization to death from any cause

  up to 5 years after surgery

Study Arms (4)

Phase Ib Experimental group

EXPERIMENTAL

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.

Drug: IBI310&Sintilimab; Procedure: Radical surgery

Phase Ib Control group

ACTIVE COMPARATOR

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.

Drug: Sintilimab; Procedure: Radical surgery

Phase III Experimental group

EXPERIMENTAL

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.

Drug: IBI310&Sintilimab

Phase III Control group

ACTIVE COMPARATOR

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.

Procedure: Radical surgery

Interventions

Sintilimab DRUG

In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.

Phase Ib Control group

IBI310&Sintilimab DRUG

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.

Phase III Experimental group; Phase Ib Experimental group

Radical surgery PROCEDURE

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

Phase III Control group; Phase Ib Control group; Phase Ib Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

sintilimab

Central Study Contacts

Jiayu Wen

CONTACT

+86-18114928232; jiayu.wen@innovnentbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: May 25, 2023
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)