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A Study of Sintilimab and Chidamide in Combination With or Without IBI305 in Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Sponsor
Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04724239
Collaborator
(none)
48
Enrollment
2
Arms
33.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305 in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be randomized in approximately a 1:1 ratio to receive sintilimab and chidamide with or without IBI305.Subjects will be randomized in approximately a 1:1 ratio to receive sintilimab and chidamide with or without IBI305.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open, Randomized Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab and Chidamide in Combination With or Without IBI305 in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: sintilimab + chidamide + IBI305

Drug: Sintilimab
200mg IV on Day 1 Q3W

Drug: Chidamide
30mg PO BIW each 3-week cycle

Drug: IBI305
7.5mg/kg IV on Day 1 Q3W
Experimental: sintilimab + chidamide

Drug: Sintilimab
200mg IV on Day 1 Q3W

Drug: Chidamide
30mg PO BIW each 3-week cycle

Outcome Measures

Primary Outcome Measures

  1. The progression-free survival (PFS) rates at 18 weeks [24 months]

Secondary Outcome Measures

  1. Objective response rate (ORR) [2 year]

  2. Progression-free survival (PFS); [2 year]

  3. Overall Survival (OS); [2 year]

  4. Disease control rate (DCR) [2 year]

  5. Duration of response (DoR) [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.

  2. Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).

  3. Subjects must have failed at least two lines of prior treatment.

  4. Subjects must have one measurable lesion according to RECIST v1.1 at least.

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  6. 18-75 years old.

  7. Life expectancy of at least 12 weeks.

  8. Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol

Exclusion Criteria:

  1. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or histone deacetylase (HDAC) inhibitor.

  2. Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication.

  3. Received radiotherapy with 4 weeks of the first dose of study medication.

  4. Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.

  5. Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll.

  6. Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.

  7. Interstitial lung disease requiring corticosteroids.

  8. Active or poorly controlled serious infections.

  9. Significant malnutrition.

  10. Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.

  11. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.

  12. Within 6 months prior to the enrollment, history of gastrointestinal perforation and/or fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn's disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea.

  13. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus

  14. Any life-threatening bleeding within 3 months prior to the enrollment.

  15. High risk of bleeding.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruihua Xu, The president of Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04724239
Other Study ID Numbers:
  • CIBI387Y101
First Posted:
Jan 26, 2021
Last Update Posted:
Feb 5, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ruihua Xu, The president of Sun Yat-sen University Cancer Center, Sun Yat-sen University
Colorectal Carcinoma, pMMR, Microsatellite-stable
Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms

Study Results

No Results Posted as of Feb 5, 2021