IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Biological: IBI310 (anti-CTLA-4 antibody); Biological: Sintilimab(anti-PD-1 antibody)

• Registration Number: NCT04258111
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-08-27
• Primary Completion: 2020-10-26
• Study Completion: 2020-10-26
• Status Verified: 2022-09
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Histologically confirmed colorectal adenocarcinoma
2. Imaging confirmed locally-advanced or metastatic colorectal cancer
3. Measurable disease by CT or MRI
4. MSI-H confirmed by central lab
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria

1. Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
2. Subjects with active,known or suspected autoimmune disease
3. Subjects with a history of primary immune deficiency
4. Subjects with severe infectious diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI310 + Sintilimab	IBI310 (anti-CTLA-4 antibody)	-
IBI310 + Sintilimab	Sintilimab(anti-PD-1 antibody)	-

Primary Outcome Measures

Name	Time	Method
ORR	Up to 3 years	Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) both by investigator and IRC	Up to 3 years
Time To Response (TTR) both by investigator and IRC	Up to 3 years
Incidence of adverse events (AE)	Up to 3 years
Duration of Response (DoR) both by investigator and IRC	Up to 3 years
Overall Survival	Up to 3 years
ORR in all MSI-H CRC patients based on investigator assessment.	Up to 3 years
Disease Control Rate (DCR) both by investigator and IRC	Up to 3 years

Trial Locations

Locations (1)

Beijing cancer hospital; 🇨🇳 Beijing, China