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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05890742
Collaborator
(none)
100
1
2
61.2
1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jun 9, 2023
Anticipated Primary Completion Date :
Apr 15, 2028
Anticipated Study Completion Date :
Jul 15, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ib Experimental group

Drug: IBI310
In arm 1,IBI310 will be used once

Procedure: Radical surgery
Radical surgery after neoadjuvant therapy

Drug: Sintilimab
In arm1&2,Sintilimab will be used twice ,q3w

Active Comparator: Ib Control group

Procedure: Radical surgery
Radical surgery after neoadjuvant therapy

Drug: Sintilimab
In arm1&2,Sintilimab will be used twice ,q3w

Outcome Measures

Primary Outcome Measures

  1. 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. [1 month after surgery]

Secondary Outcome Measures

  1. Major Pathological Response, MPR, defined as the proportion of subjects with ≤ 10% residual survivable tumor in the removed primary tumor after neoadjuvant therapy [1 month after surgery]

  2. Event Free Survival, EFS, defined as the time from randomization until first determined by RECIST v1.1 to be inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first [3 years after surgery]

  3. R0 tumor resection rate, defined as the proportion of subjects with R0 excision [1 week after surgery]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

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:
NCT05890742
Other Study ID Numbers:
  • CIBI310L301
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2023