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

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ClinicalTrials.gov Identifier: NCT04258111
Recruitment Status : Active, not recruiting
First Posted : February 6, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: IBI310 (anti-CTLA-4 antibody) Biological: Sintilimab(anti-PD-1 antibody) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. ORR [ Time Frame: Up to 3 years ]
    Objective Response Rate (ORR) in all MSI-H CRC patients as determined by independent review committee


Secondary Outcome Measures :
  1. ORR in all MSI-H CRC patients based on investigator assessment. [ Time Frame: Up to 3 years ]
  2. Progression-Free Survival (PFS) both by investigator and IRC [ Time Frame: Up to 3 years ]
  3. Disease Control Rate (DCR) both by investigator and IRC [ Time Frame: Up to 3 years ]
  4. Duration of Response (DoR) both by investigator and IRC [ Time Frame: Up to 3 years ]
  5. Time To Response (TTR) both by investigator and IRC [ Time Frame: Up to 3 years ]
  6. Overall Survival [ Time Frame: Up to 3 years ]
  7. Incidence of adverse events (AE) [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258111


Locations
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China
Beijing cancer hospital
Beijing, China
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04258111    
Other Study ID Numbers: CIBI310D201
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Microsatellite Instability
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genomic Instability
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs