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NCT04258111 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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