A Phase 2 interventional study of Sintilimab and Ipilimumab N01 in Peritoneal Mesothelioma and First-line Therapy, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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).
Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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.
PFS
Progression-free survival
Time frame: 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
ORR
Objective response rate
Time frame: 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
disease control rate
Time frame: 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
overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to approximately 36 months
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sintilimab · Ipilimumab N01 · Bevacizumab