Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM

August 3, 2024 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Single-Arm, Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma

To explore the efficacy and safety of sintilimab, bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma, and to explore the biomarkers related to efficacy or safety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-arm study aims to enroll 28 patients with unresectable malignant peritoneal mesothelioma. Enrolled patients will undergo treatment with sintilimab (200 mg), bevacizumab (7.5 mg/kg), pemetrexed (500 mg/m^2), and cisplatin (75 mg/m^2) administered every three weeks. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria, and after six cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs. The primary outcome measure of the study is Progression-Free Survival (PFS), while secondary outcomes include Overall Survival (OS), Objective Response Rate (ORR), and Disease Control Rate (DCR).

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2

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 Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Cancer Institute and Hospital,Chinese Academy of Medical Sciences
        • 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. Fully understand the study and voluntarily sign the informed consent form;
  2. Age ≥18 years old;
  3. Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma;
  4. ECOG performance status of 0-1;
  5. Expected survival of ≥3 months;
  6. Function of vital organs must meet the following criteria (use of any blood products and cell growth factors is not allowed within 14 days prior to enrollment): Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90g/L; Total bilirubin <1.5 times the upper limit of normal (ULN); ALT and AST <2.5×ULN, GPT ≤1.5×ULN; Serum creatinine ≤1×ULN; Creatinine clearance rate >60 ml/min (Cockcroft-Gault formula);
  7. Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication; for men, must be surgically sterilized or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication;
  8. Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. -

Exclusion Criteria:

  1. Unable to adhere to the study protocol or procedures;
  2. Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period;
  3. Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer;
  4. Active autoimmune diseases or a history of autoimmune diseases within 4 weeks prior to enrollment;
  5. Previous allogeneic bone marrow or organ transplantation;
  6. Serious cardiovascular diseases within 6 months prior to enrollment, including unstable angina or myocardial infarction;
  7. Allergy to study drugs or any of their excipients;
  8. International Normalized Ratio (INR) >1.5 or Partial Thromboplastin Time (APTT) >1.5×ULN;
  9. Electrolyte abnormalities of clinical significance as judged by the investigator;
  10. Uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
  11. Evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding >30 mL, including hematemesis, melena, hematochezia), hemoptysis (more than 5 mL of fresh blood within 4 weeks) or a thromboembolic event (including stroke and/or transient ischemic attack) within the past 12 months;
  12. Significant cardiovascular diseases of clinical importance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within the past 6 months; congestive heart failure New York Heart Association (NYHA) class >2; ventricular arrhythmias requiring medication; Left Ventricular Ejection Fraction (LVEF) <50%;
  13. Active or uncontrolled severe infections (≥CTCAE v5.0 Grade 2);
  14. Known Human Immunodeficiency Virus (HIV) infection. Clinically significant liver disease history, including viral hepatitis [active Hepatitis B Virus (HBV) infection must be excluded, i.e., HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL); known Hepatitis C Virus (HCV) infection and HCV RNA positive (>1×10^3 copies/mL)];
  15. Any other diseases, clinically significant metabolic dysfunctions, physical examination findings, or laboratory findings that, in the judgment of the investigator, make the patient unsuitable for the study drug (e.g., requiring treatment for epilepsy), could interfere with the interpretation of study results, or place the patient at high risk;
  16. Urinalysis indicating urine protein ≥2+ and 24-hour urine protein >1.0g;
  17. Complications requiring long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (more than 10mg/day of prednisone or equivalent therapeutic hormones);
  18. Patients deemed unsuitable for the study by the investigator.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
Sintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin
Drug: Sintilimab, Bevacizumab , Pemetrexed , Cisplatin
Sintilimab: 200mg, bevacizumab: 7.5mg/kg, pemetrexed: 500mg/m2, cisplatin: 75mg /m2, Q3w. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria. After 6 cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs.
Other Names:
  • Sintilimab+Bevacizumab+Pemetrexed+ Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 36 months
The time from the date of first administration of this regimen to the date of first documented disease progression or death due to any cause.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 36 months
The time from the initiation of the first dose of medication in a patient to death from any cause.
36 months
Objective Response Rate (ORR)
Time Frame: 36 months
The proportion of patients with a comfirmed complete response or patial response using RECIST1.1.
36 months
Disease Control Rate (DCR)
Time Frame: 36 months
The percentage of patients who have achieved complete response, partial response, and stable disease to the treatment, as defined by RECIST 1.1 criteria.
36 months

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Yongkun Sun, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical SciencesCancer

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)

January 31, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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