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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: IBI310 (anti-CTLA-4 antibody); Biological: Sintilimab(anti-PD-1 antibody)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI310 + Sintilimab	Biological: IBI310 (anti-CTLA-4 antibody); Specified dose on specified days; Biological: Sintilimab(anti-PD-1 antibody); Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Up to 3 years
ORR in all MSI-H CRC patients based on investigator assessment.	Up to 3 years
Progression-Free Survival (PFS) both by investigator and IRC	Up to 3 years
Disease Control Rate (DCR) both by investigator and IRC	Up to 3 years
Duration of Response (DoR) 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Genomic Instability; Colorectal Neoplasms; Microsatellite Instability; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins
• Other Study ID Numbers: CIBI310D201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No