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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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04258111
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
32.1
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: IBI310 (anti-CTLA-4 antibody)
  • Biological: Sintilimab(anti-PD-1 antibody)
 Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 27, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. ORR [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. [Up to 3 years]

  2. Progression-Free Survival (PFS) both by investigator and IRC [Up to 3 years]

  3. Disease Control Rate (DCR) both by investigator and IRC [Up to 3 years]

  4. Duration of Response (DoR) both by investigator and IRC [Up to 3 years]

  5. Time To Response (TTR) both by investigator and IRC [Up to 3 years]

  6. Overall Survival [Up to 3 years]

  7. Incidence of adverse events (AE) [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing cancer hospital Beijing China

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04258111
Other Study ID Numbers:
  • CIBI310D201
First Posted:
Feb 6, 2020
Last Update Posted:
Dec 17, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms
Microsatellite Instability
Antibodies
Immunoglobulins

Study Results

No Results Posted as of Dec 17, 2020