MesotheliomaPhase 2NCT07514793
Iparomlimab Plus Tovorilimab Combined With Bevacizumab and Chemotherapy as First-Line Treatment for Advanced Mesothelioma
A Phase 2 study testing Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin in people with Mesothelioma, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab in combination with bevacizumab and chemotherapy as first-line treatment for advanced mesothelioma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female patients aged 18 to 75 years (inclusive).
- Histopathologically confirmed advanced mesothelioma.
- No prior systemic therapy.
- At least one measurable lesion according to mRECIST 1.1 and RECIST 1.1 criteria.
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
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- Adequate major organ function, meeting the following laboratory criteria: Hemoglobin (Hb) ≥ 90 g/L.White blood cell count ≥ 3.0 × 10⁹/L.Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.Platelet count (PLT) ≥ 100 × 10⁹/L.Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.Serum creatinine clearance (CrCl) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
- Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Subjects agree to use effective contraceptive methods from the time of signing informed consent until 120 days after the last dose of study drug. Female subjects of childbearing potential must have a negative urine pregnancy test within 7 days before the start of treatment and must be non-lactating. A female patient is considered to have childbearing potential if she has experienced menarche, has not reached a postmenopausal state (≥12 consecutive months of amenorrhea with no identified cause other than menopause), and has not undergone sterilization surgery (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- Subjects voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and agree to cooperate with follow-up.
Who cannot join
- Prior systemic anti-tumor therapy, except for patients who relapsed more than six months after completion of adjuvant chemotherapy.
- Known history of hypersensitivity to macromolecular protein preparations, or contraindication or allergy to any component of iparomlimab and tuvoraleimab, bevacizumab, pemetrexed, or platinum-based agents.
- Major surgery (excluding diagnostic laparoscopy; local surgical treatment of isolated lesions is acceptable) within 28 days before the first dose.
- History of allogeneic tissue/solid organ transplantation.
- Presence of any condition requiring systemic corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors) within 2 weeks before the first dose. Topical corticosteroids, nasal sprays, and inhaled steroids are permitted. Systemic corticosteroids for prophylaxis of contrast allergy are allowed.
- Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable dose of hormone replacement therapy; type I diabetes mellitus requiring only stable dose of insulin replacement therapy.
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- Other active malignancy within the past 5 years, except for cured locally treatable cancers (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or in situ cervical or breast cancer) and breast cancer that has not recurred for >3 years after radical surgery.
- History of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- Symptomatic, untreated, or clinically unstable brain metastases or leptomeningeal metastases.
- Poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or poorly controlled diabetes despite standard treatment, or uncontrolled symptomatic arrhythmia.
- Thromboembolic events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction, or pulmonary embolism) within 6 months before the start of study treatment.
- Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV) within the past 12 months.
- Participation in another clinical trial within the past 60 days or during the study treatment period.
- Known active HIV, HBV, or HCV infection.
- Any other condition that, in the investigator's judgment, may interfere with the conduct of the study or the interpretation of the results, or renders the patient unsuitable for enrollment.
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 cancer hospital
Shanghai
xin Liu, 021-64175590-88503, jeanettexin@hotmail.com
About this study
Official title: Iparomlimab Plus Tovorilimab Combined With Bevacizumab and Chemotherapy as First-Line Treatment for Advanced Mesothelioma: A Single-Arm, Multicenter, Phase II Clinical Trial
This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab in combination with bevacizumab and chemotherapy as first-line treatment for advanced mesothelioma.
- Conditions
- Mesothelioma
- Being tested
- Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+CisplatinDrug
Iparomlimab and Tuvoraleimab: 5 mg/kg each, on Day 1, intravenous injection, every 3 weeks (Q3W);
Bevacizumab: 7.5 mg/kg, on Day 1, intravenous infusion, Q3W;
Pemetrexed: 500 mg/m², on Day 1, intravenous infusion, Q3W;
Platinum-based agent: either Cisplatin 75 mg/m² on Day 1, intravenous infusion, Q3W, or Carboplatin AUC = 5 on Day 1, intravenous infusion, Q3W; the specific agent is at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin | Experimental | Not described Receives: Drug: Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined as the percentage of subjects achieving complete response (CR) or partial response (PR).
Measured: up to 2 years
Secondary outcomes (5)
Disease control rate (DCR)
Defined as the percentage of participants in the analysis population who achieved Complete Response, Partial Response, or Stable Disease.
Measured: up to 2 years
Duration of Response (DoR)
Defined as the time from the first tumor assessment showing response (complete response [CR] or partial response [PR]) to disease progression or death, whichever occurs first, in patients who achieve CR or PR.
Measured: up to 2 years
Progression-Free Survival (PFS)
Defined as the time from enrollment to the date of first documented tumor progression (as assessed per mRECIST 1.1 and RECIST v1.1 criteria, regardless of whether treatment is continued) or death from any cause, whichever occurs first.
Measured: up to 2 years
Overall Survival (OS)
Defined as the time from the initiation of treatment until death from any cause.
Measured: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514793
- Sponsor's protocol ID
- QIBA-MPM/PM-01
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab Plus Tovorilimab Combined With Bevacizumab and Chemotherapy as First-Line Treatment for Advanced Mesothelioma: A Single-Arm, Multicenter, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07514793
- Acronym / sponsor ID
- QIBA-MPM/PM-01
- Conditions
- Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab in combination with bevacizumab and chemotherapy as first-line treatment for advanced mesothelioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin | Experimental | Drug: Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Both male and female patients aged 18 to 75 years (inclusive).
- Histopathologically confirmed advanced mesothelioma.
- No prior systemic therapy.
- At least one measurable lesion according to mRECIST 1.1 and RECIST 1.1 criteria.
- Life expectancy ≥ 3 months.
Key exclusion criteria (15 listed)
- Prior systemic anti-tumor therapy, except for patients who relapsed more than six months after completion of adjuvant chemotherapy.
- Known history of hypersensitivity to macromolecular protein preparations, or contraindication or allergy to any component of iparomlimab and tuvoraleimab, bevacizumab, pemetrexed, or platinum-based agents.
- Major surgery (excluding diagnostic laparoscopy; local surgical treatment of isolated lesions is acceptable) within 28 days before the first dose.
- History of allogeneic tissue/solid organ transplantation.
- Presence of any condition requiring systemic corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors) within 2 weeks before the first dose. Topical corticosteroids, nasal sprays, and inhaled steroids are permitted. Systemic corticosteroids for prophylaxis of contrast allergy are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+CisplatinIparomlimab and Tuvoraleimab: 5 mg/kg each, on Day 1, intravenous injection, every 3 weeks (Q3W); Bevacizumab: 7.5 mg/kg, on Day 1, intravenous infusion, Q3W; Pemetrexed: 500 mg/m², on Day 1, intravenous infusion, Q3W; Platinum-based agent: either Cisplatin 75 mg/m² on Day 1, intravenous infusion, Q3W, or Carboplatin AUC = 5 on Day 1, intravenous infusion, Q3W; the specific agent is at the investigator's discretion. | Drug | Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
Defined as the percentage of subjects achieving complete response (CR) or partial response (PR).
5 secondary outcomes
Disease control rate (DCR)
Time frame: up to 2 years
Duration of Response (DoR)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin in people with Mesothelioma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xin Liu (021-64175590-88503, jeanettexin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.