A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

March 11, 2024 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
  2. At least 18 years old.
  3. Primary colon adenocarcinoma was histologically confirmed.
  4. Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
  5. MSI-H or dMMR.
  6. Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
  7. Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
  8. The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.

Exclusion Criteria:

  1. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
  2. Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy.
  3. Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
  4. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ib Experimental group
In Phase Ib Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer.
Drug: IBI310&Sintilimab
In ARM Phase Ib&III Experimental group，IBI310&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
Procedure: Radical surgery
In ARM Phase Ib&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy
Active Comparator: Phase Ib Control group
In Phase Ib Control group，subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer.
Procedure: Radical surgery
In ARM Phase Ib&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy
Drug: Sintilimab
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
Experimental: Phase III Experimental group
In Phase III Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) & Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only. Followed by radical surgery for colon cancer. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery.
Drug: IBI310&Sintilimab
In ARM Phase Ib&III Experimental group，IBI310&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
Active Comparator: Phase III Control group
In Phase III Control group, subjects will receive radical surgery without neoadjuvant therapy. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery.
Procedure: Radical surgery
In ARM Phase Ib&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Time Frame: 1 month after surgery
The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
1 month after surgery
Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
Time Frame: up to 5 years after surgery
The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
up to 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 tumor resection rate, defined as the proportion of subjects with R0 excision
Time Frame: 2 week after surgery
The proportion of subjects with R0 excision
2 week after surgery
Overall-survival(OS), defined as the time from randomization to death from any cause
Time Frame: up to 5 years after surgery
The time from randomization to death from any cause
up to 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Estimated)

April 15, 2028

Study Completion (Estimated)

July 15, 2028

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI310L301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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