Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM

NCT06543069 | Recruiting Phase 2

• 1 other identifier: NCC4469
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Peritoneal Mesothelioma, Advanced

Keywords

Sintilimab; Bevacizumab; Pemetrexed; Cisplatin; Malignant Peritoneal Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (3)

• Overall Survival (OS)

  36 months

• Objective Response Rate (ORR)

  36 months

• Disease Control Rate (DCR)

  36 months

Study Arms (1)

single arm

EXPERIMENTAL

Sintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin

Drug: Sintilimab, Bevacizumab , Pemetrexed , Cisplatin

Interventions

Sintilimab, Bevacizumab , Pemetrexed , Cisplatin DRUG

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.

Also known as: Sintilimab+Bevacizumab+Pemetrexed+ Cisplatin

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the study and voluntarily sign the informed consent form;
• Age ≥18 years old;
• Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma;
• ECOG performance status of 0-1;
• Expected survival of ≥3 months;
• 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);
• 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;
• Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. -

You may not qualify if:

• Unable to adhere to the study protocol or procedures;
• Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period;
• Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer;
• Active autoimmune diseases or a history of autoimmune diseases within 4 weeks prior to enrollment;
• Previous allogeneic bone marrow or organ transplantation;
• Serious cardiovascular diseases within 6 months prior to enrollment, including unstable angina or myocardial infarction;
• Allergy to study drugs or any of their excipients;
• International Normalized Ratio (INR) \>1.5 or Partial Thromboplastin Time (APTT) \>1.5×ULN;
• Electrolyte abnormalities of clinical significance as judged by the investigator;
• Uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
• 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;
• 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%;
• Active or uncontrolled severe infections (≥CTCAE v5.0 Grade 2);
• Known Human Immunodeficiency Virus (HIV) infection. Clinically significant liver disease history, including viral hepatitis \[active Hepatitis B Virus (HBV) infection must be excluded, i.e., HBV DNA positive (\>1×10\^4 copies/mL or \>2000 IU/mL); known Hepatitis C Virus (HCV) infection and HCV RNA positive (\>1×10\^3 copies/mL)\];
• 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;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital,Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Interventions

sintilimab; Bevacizumab; Pemetrexed; Cisplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yongkun Sun, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical SciencesCancer

  STUDY CHAIR

Central Study Contacts

Yongkun Sun

CONTACT

13141276041; hsunyk@cicams.ac.cn

Yuting Fang

CONTACT

13700902492; fangyuting502@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: January 31, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)