Peritoneal MesotheliomaPhase 2PeMNCT07893340
First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma
A Phase 2 study testing Sintilimab, Ipilimumab N01 and Bevacizumab in people with Peritoneal Mesothelioma and First-line Therapy, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Mesothelioma, First-line Therapy
- What is being tested?
- Sintilimab, Ipilimumab N01 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 30 Sep 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality
Wanjing Feng, 021-64175590, 1915659989@qq.com
About this study
Official title: Sintilimab Combined With Ipilimumab N01 and Bevacizumab for First-line Treatment of Unresectable Malignant Peritoneal Mesothelioma: a Single-arm, Phase II Clinical Study
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
- Being tested
- Sintilimab, Ipilimumab N01, Bevacizumab
- Keywords
- MPeM, Immunotherapy, CTLA4 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
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 N01Drug
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.
BevacizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sintilimab; Drug: Ipilimumab N01; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 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
Objective response rate
Measured: 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
Measured: 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
Measured: From date of enrollment until the date of death from any cause, assessed up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MesotheliomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893340
- Sponsor's protocol ID
- FDZL-SIMB
- Acronym
- PeM
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No