First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma

NCT07893340 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FDZL-SIMB
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, single-arm, Phase II clinical study evaluating the efficacy and safety of sintilimab in combination with ipilimumab N01 and bevacizumab as first-line treatment in patients with unresectable malignant peritoneal mesothelioma. Eligible patients will receive sintilimab plus ipilimumab N01 and bevacizumab until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons, with a maximum treatment duration of 24 months. The primary endpoint is progression-free survival (PFS).

Conditions

Peritoneal Mesothelioma; First-line Therapy

Keywords

MPeM; Immunotherapy; CTLA4 inhibitor

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 24 months

Secondary Outcomes (3)

• ORR

  The proportion of subjects achieving complete response (CR) or partial response (PR) among all enrolled subjects; assessed per RECIST 1.1 every 6 weeks until disease progression or death, assessed up to approximately 12 months

• DCR

  The proportion of subjects achieving CR, PR, or stable disease (SD) among all enrolled subjects; assessed per RECIST 1.1 every 6 weeks until disease progression or death, assessed up to approximately 12 weeks

• OS

  From date of enrollment until the date of death from any cause, assessed up to approximately 36 months

Study Arms (1)

Sintilimab + Ipilimumab N01 + Bevacizumab

EXPERIMENTAL

Each treatment cycle is 6 weeks. Sintilimab: 200 mg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Ipilimumab N01: 1 mg/kg IV, D1, Q6W (Day 1 of every 6 weeks) Bevacizumab: 15 mg/kg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

Drug: Sintilimab; Drug: Ipilimumab N01; Drug: Bevacizumab

Interventions

Sintilimab DRUG

Sintilimab: 200 mg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

Sintilimab + Ipilimumab N01 + Bevacizumab

Ipilimumab N01 DRUG

Ipilimumab N01: 1 mg/kg IV, D1, Q6W (Day 1 of every 6 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

Sintilimab + Ipilimumab N01 + Bevacizumab

Bevacizumab DRUG

Bevacizumab: 15 mg/kg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

Sintilimab + Ipilimumab N01 + Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Have fully understood the study and voluntarily signed the informed consent;
• Age≥ 18 years, gender not restricted;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1, with an expected survival period of more than 3 months;
• Metastatic or locally advanced unresectable peritoneal mesothelioma confirmed by pathology or histology;
• At least one evaluable lesion (according to RECIST 1.1 criteria);
• Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN), subjects with asymptomatic abnormalities of T3, FT3, or FT4 are eligible.
• Adequately controlled blood pressure.
• Have not received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) for unresectable advanced or metastatic peritoneal mesothelioma;
• Laboratory test data within 7 days before screening (including 7 days) should meet the following requirements: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 9g/dL, total serum bilirubin ≤ 3 times the upper limit of normal (ULN); ALT and AST ≤ 5 x ULN; albumin ≥ 28g/L; serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 50ml/min; INR≤1.5 x ULN, APTT≤1.5 x ULN; urinalysis showing urine protein \< 2+, for subjects with urine protein ≥ 2+ at baseline, a 24-hour urine collection must be performed and the 24-hour urine protein must be \< 1 g.
• Fertile female must have a negative serum pregnancy test within 3 days before first dose.
• Fertile female and male patients with female partners of childbearing potential must use a highly effective contraceptive method (annual failure rate \< 1 %) from 7 days before first dose until 120 days after the last dose.

You may not qualify if:

• Pregnant or lactating women, and women of childbearing age who have not taken adequate contraceptive measures;
• Patients with a history of other malignant tumors within 5 years, except for those with a history of cured cervical carcinoma in situ or non-melanoma skin cancer;
• Patients with the following severe or uncontrolled diseases: severe heart disease, unstable condition despite treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, significant pericardial effusion or unstable arrhythmia within 6 months before enrollment; definite neurological or psychiatric disorders, including dementia or epileptic seizures; severe or uncontrolled infections; active disseminated intravascular coagulation, or patients with obvious bleeding tendencies;
• Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.
• Presence of any active autoimmune disease or history of autoimmune disease.
• History of allogeneic haematopoietic stem-cell or solid-organ transplantation.
• Hypertension uncontrolled by medication before enrollment, defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
• Other conditions where the investigator deems the patient unsuitable for participation in this trial;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xiaodong Zhu

CONTACT

18017312567; xddr001@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: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)