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

MSI-H Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890742
• Other study ID #: CIBI310L301
• Status: Recruiting
• Phase: Phase 3
• Start date: May 25, 2023
• Est. completion date: July 15, 2028

Study information

• Verified date: March 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Jiayu Wen
• Phone: +86-18114928232
• Email: jiayu.wen[@]innovnentbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 15, 2028
• Est. primary completion date: April 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• MSI-H

Intervention

Drug:
• Sintilimab
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
• IBI310&Sintilimab
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.

Procedure:
• Radical surgery
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

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	R0 tumor resection rate, defined as the proportion of subjects with R0 excision	The proportion of subjects with R0 excision	2 week after surgery
Secondary	Overall-survival(OS), defined as the time from randomization to death from any cause	The time from randomization to death from any cause	up to 5 years after surgery