Phase 2 Mesothelioma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to take part before any trial-related procedures begin, and who are willing and able to attend scheduled visits and follow testing requirements.
• People who have been diagnosed with Pleural Mesothelioma confirmed through a tissue biopsy (not from fluid samples alone), ideally taken by thoracoscopy and certified by a recognised expert pathology panel.
• People whose mesothelioma has been confirmed as progressing on scans (CT with contrast dye), measured using specific guidelines, after receiving up to 2 previous treatment lines — including immunotherapy (nivolumab with or without ipilimumab) and standard chemotherapy (pemetrexed/platinum, with or without bevacizumab in a limited number of patients), in any order, or as a combination first-line treatment.
• People who have measurable disease on scans according to standard mesothelioma measurement guidelines.
• People with a good general performance status, scored 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activity).
• People who have lost less than 10% of their body weight in the 3 months before joining the study.
• People aged 18 years or older.
• People with a life expectancy of more than 3 months.
• People who have tissue samples available (at least 10 slides from biopsy) for central laboratory testing; if samples are insufficient or unavailable, eligibility may still be considered after discussion with the trial team (confirm with trial site).
• People whose blood test results show adequate kidney, liver, bone marrow, and clotting function, meeting specific thresholds set by the trial (confirm with trial site for exact values).
• Women who could become pregnant must use highly effective contraception for 28 days before and 6 months after treatment, and must have a negative pregnancy test within 24 hours before starting treatment.
• Men who are sexually active with women who could become pregnant must use effective contraception during treatment and for 6 months after the last dose.
• People who are covered by a national health insurance scheme.

Who may not be able to join:

• People with a general performance status score above 1 on the ECOG scale (meaning significant limitation in daily activity).
• People who have already received more than 2 lines of treatment for their mesothelioma, or who previously received bevacizumab or similar anti-blood vessel drugs outside of the allowed combinations.
• People whose mesothelioma appeared to grow very rapidly while on previous immunotherapy (progression within 9 weeks of starting that treatment).
• People whose only abnormality on scans is a pleural fluid collection, with no measurable pleural thickening or enlarged lymph nodes.
• People whose mesothelioma affects only the abdomen, heart lining, or testicular lining, with no involvement of the chest lining at the time of diagnosis.
• People diagnosed with a glandular-type cancer (adenocarcinoma) from any part of the body within the past 3 years, with a specific exception for certain low-risk localised prostate cancers treated with surgery or radiotherapy only (confirm with trial site).
• People with any other active or previous cancer diagnosed within the past 3 years, except for certain treated skin cancers or treated cervical in-situ cancer.
• People with uncontrolled fluid buildup around the lung requiring drainage more often than every 21 days — although people with a long-term drainage catheter in place may still be considered.
• People with brain metastases that are causing symptoms and have not been treated; people with symptom-free brain metastases not requiring high-dose steroids may be considered.
• People who need radiotherapy at the time of starting trial treatment, except for pain-relieving radiotherapy to bones not involving target lesions.
• People with a history of a weakened immune system, organ transplant requiring immune-suppressing drugs, use of immune-suppressing medication in the 28 days before enrolment, or a severe (grade 3 or 4) immune-related reaction to a previous immunotherapy.
• People taking corticosteroid tablets or injections at a dose above 10 mg prednisone equivalent daily within 14 days before starting treatment; inhaled, nasal, or skin-applied steroids are allowed.
• People with an active autoimmune disease that requires immune-suppressing treatment, including conditions such as rheumatoid arthritis, myasthenia, lupus, multiple sclerosis, and others listed in the trial criteria; some milder or well-controlled conditions may still be permitted (confirm with trial site).
• People with active inflammatory bowel disease or serious uncontrolled chronic gut problems causing ongoing diarrhoea.
• People with pre-existing moderate or severe scarring/inflammation of the lung tissue (interstitial lung disease) significantly affecting lung function.
• People who have had major surgery or serious injury within 4 weeks before joining, or who are planning major surgery within 4 weeks after the first dose; minor procedures within 3 days before registration are also excluded.
• People with a history of significant bleeding problems, blood clotting disorders, or clinically important bleeding in the 4 weeks before joining, including coughing up blood, stomach or bowel bleeding, or a current need for blood-thinning treatment (preventive anticoagulation for clots is generally allowed — confirm with trial site).
• People with high blood pressure that remains at or above 150/100 mmHg even while taking blood pressure medication.
• People with certain serious heart or blood vessel conditions in the past 12 months, including heart attack, unstable chest pain, significant heart failure, or poorly controlled heart rhythm problems.
• People with a history of bleeding from the oesophagus or stomach, serious ulcers, or abdominal abscesses or fistulas within the past 6 months.
• People with a history of serious blood clots in arteries, stroke, or related events within the past 6 months.
• People who have had a sudden worsening of chronic lung disease (COPD flare) within the past 4 weeks.
• People with a history of a hole or blockage in the gut, or major bowel surgery within the past 6 months.
• People whose scans show cancer wrapping around or invading major lung blood vessels, or a cavity forming inside a lung tumour.
• People with active uncontrolled infections, including active tuberculosis or active hepatitis B or C; people with past resolved infections may be considered (confirm with trial site).
• People living with HIV who have not been on effective HIV treatment for at least 4 weeks and who have a detectable viral load above 200 copies/mL.
• People who have received a live vaccine within the 30 days before joining; mRNA and adenovirus-based COVID-19 vaccines are permitted.
• People who, in the investigator's judgement, would be unable to follow the study requirements.
• People with a known allergy or sensitivity to the study treatment or any of its ingredients.
• People currently participating in another clinical trial or receiving another experimental treatment.
• People who are under legal protection or who are unable to give their own consent.

Important: Always verify eligibility with the trial site directly before applying.