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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04258111

Enrollment

Registered

2020-02-06

Start date

2020-08-27

Completion date

2020-10-26

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

BIOLOGICALIBI310 (anti-CTLA-4 antibody)

Specified dose on specified days

BIOLOGICALSintilimab(anti-PD-1 antibody)

Specified dose on specified days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Overall Survival	Up to 3 years
Incidence of adverse events (AE)	Up to 3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026