New immune cocktail takes on deadly mesothelioma
NCT ID NCT07514793
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding two immune-boosting drugs (iparomlimab and tovorilimab) to standard chemotherapy and bevacizumab can shrink tumors in people with advanced mesothelioma who have not had prior treatment. About 37 participants will receive the combination every three weeks. The main goal is to see how many patients respond, with secondary aims of controlling the disease and prolonging response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iparomlimab and tovorilimab (immune-boosting drugs) plus bevacizumab (anti-angiogenic drug) and chemotherapy (pemetrexed and cisplatin or carboplatin)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option that shrinks tumors and controls advanced mesothelioma for longer.
- What could go wrong
- This is a small, early-phase trial with only 37 participants and no comparison group. The added drugs may increase side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
Apr 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced mesothelioma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fudan university cancer hospital
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug VT3989 takes on chemo in mesothelioma survival test
- Which palliative care approach boosts quality of life in advanced lung cancer?
- Can a Chest-Injected drug drain Cancer's fluid trap?
- Abdominal chemotherapy after surgery may improve mesothelioma outcomes
- New imaging tracer could spot hidden cancers and fibrosis in one scan
- Experimental pill SHY-ONC6 takes on Hard-to-Treat cancers