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

Colorectal Cancer Clinical Trial

Official title:

An Open-label, Multicenter, Phase 2 Study of IBI310 in Combination With Sintilimab in Patients With DNA Mismatch Repair Deficient (dMMR) /Microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04258111
• Other study ID #: CIBI310D201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 27, 2020
• Est. completion date: May 2023

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: May 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Microsatellite Instability

Intervention

Biological:
• IBI310 (anti-CTLA-4 antibody)
Specified dose on specified days
• Sintilimab(anti-PD-1 antibody)
Specified dose on specified days

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing

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