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:

• Adults aged 18 or older.
• People who have been diagnosed (confirmed by tissue testing) with certain advanced or spreading cancers, including: melanoma, pleural mesothelioma, kidney cancer (renal cell carcinoma), a specific type of bowel cancer (MSI-high or mismatch repair-deficient colorectal cancer), liver cancer (hepatocellular carcinoma), a type of lung cancer without certain genetic changes (non-small cell lung cancer with no EGFR or ALK mutations), or other cancer types for which a specific drug combination (ipilimumab and nivolumab) has been approved by the FDA. Prior treatment with certain immunotherapy drugs (anti PD-1/PD-L1) is permitted.
• People whose blood counts meet certain minimum levels — specifically, adequate white blood cells, red blood cells, and platelets — without needing recent transfusions or growth factor support (confirm exact values with trial site).
• People who are considered generally well enough to carry out normal daily activities, as measured by a standard scale (ECOG performance status of 0 or 1).
• People whose life expectancy is estimated to be more than 12 weeks.
• People whose kidneys and liver are functioning at an adequate level, as measured by standard blood tests (confirm specific values with trial site). People with liver tumours may meet a slightly different liver function threshold (confirm with trial site).
• Men who are sexually active with women who could become pregnant must be willing to use contraception during treatment and for a set period after the last dose of the study drug. Women who could become pregnant must have been using contraception for at least 3 months before starting treatment and must be willing to continue contraception during treatment and for a set period after the last dose.
• People whose side effects from previous cancer treatments have mostly resolved back to mild or baseline levels before joining.
• People who have measurable disease that can be tracked using standard imaging criteria (RECIST).
• People who are willing to provide blood samples for research purposes.

Who may not be able to join:

• People who have received cancer treatment or radiation therapy within the past 3 weeks, or who have had major surgery within the past 4 weeks. Different timing rules may apply to certain types of drugs (confirm with trial site).
• People with active, spreading cancer in the brain or surrounding tissue. People with previously treated brain tumours may still be considered if their condition has been stable for at least 4 weeks and they have not needed steroid medication for at least 2 weeks (confirm with trial site).
• People who have previously experienced severe (Grade 3 or higher) immune-related side effects such as serious bowel inflammation, lung inflammation, severe skin reactions, or severe liver enzyme increases from prior treatment. People with stable hormone-related side effects (such as an underactive thyroid or adrenal problems) may still be considered (confirm with trial site).
• People who still have ongoing side effects from previous treatments that are rated above mild (Grade 1), with some exceptions — for example, mild-to-moderate nerve tingling, hair loss, or underactive thyroid, or other moderate side effects that are well controlled with medication, may be acceptable (confirm with trial site).
• People currently taking, or who have taken within the past 2 weeks, certain medications or foods that strongly affect how the body processes a specific liver enzyme pathway (CYP3A), which could interact with the study drug (confirm specific medications with trial site).
• People with certain heart conditions, including: heart muscle inflammation (myocarditis); poorly controlled high blood pressure despite treatment; uncontrolled chest pain; certain heart rhythm problems; heart failure; prior or current weakened heart muscle (cardiomyopathy); uncontrolled irregular heart rhythm with a fast heart rate; a recent heart attack (within the past 6 months); frequent need for nitrate medications; use of medications known to cause a specific dangerous heart rhythm problem (Torsades de Pointes); or an abnormal heart electrical reading (QTcF of 470 ms or more on an ECG).
• People who have a known history of HIV, or who test positive for hepatitis B or hepatitis C.
• People who currently have another active cancer, with some exceptions: people whose other cancer was fully treated at least 2 years ago with no sign of return may be eligible, as may people with a clinically stable second cancer that does not need treatment, at the investigator's discretion. Certain treated skin cancers are also permitted (confirm with trial site).
• People who do not meet the contraception requirements described in the inclusion criteria above.
• People with serious uncontrolled medical conditions that could make participation unsafe, such as uncontrolled diabetes, active severe infection, severe malnutrition, or severe ongoing liver or kidney disease.
• People currently using, or who have used within the past 14 days, corticosteroids (such as prednisone) or other immune-suppressing medications, with certain limited exceptions including low-dose inhaled, topical, or nasal steroids, low-dose replacement steroids for hormone deficiency, or short-course steroids used to manage infusion reactions (confirm with trial site).
• People who have received a live vaccine within 28 days before the first dose of the study drug.
• People with serious autoimmune diseases, such as active inflammatory bowel disease (Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, lupus, or autoimmune vasculitis.
• People with active or prior drug-induced lung inflammation, idiopathic pulmonary fibrosis, interstitial lung disease, or other lung conditions that may affect the ability to assess lung-related side effects. A history of radiation-related lung inflammation in a previously treated area is permitted.
• People who have taken part in another clinical trial within 21 days of enrolling, or within 5 half-lives of that study drug, whichever is shorter.
• People who require mechanical breathing support, have low resting oxygen levels (below 90% on room air), require kidney dialysis, require blood pressure support medications, or have a serious liver circulation condition.
• People who have a proven or suspected active whole-body infection requiring intravenous antibiotics.
• People who are pregnant or currently breastfeeding. Women who could become pregnant must have a negative pregnancy blood test within 1 week before starting treatment. Women who are post-menopausal or have had a documented surgical procedure resulting in permanent sterility (performed at least 6 months prior) may be considered as not requiring pregnancy testing — confirm specific definitions with the trial site. Note: tubal ligation is not considered permanent sterilisation under this trial's criteria.
• People with psychiatric illness or personal circumstances that would make it difficult to follow the study requirements or to give proper informed consent.
• People who have previously received an organ or tissue transplant from another person. Prior T-cell therapy is permitted.
• People taking biotin (Vitamin B7) supplements in amounts higher than 30 micrograms per day. People who reduce their biotin intake to 30 micrograms per day or less may be eligible (confirm with trial site).
• People with any other condition that the investigating doctor feels may affect safe participation in the trial.
• People with active stomach ulcers, stomach inflammation (gastritis), active diverticulitis, other serious bowel disease involving diarrhoea within the past 2 years, or any digestive condition that affects how oral medications are absorbed.
• People with a known allergy to soy.

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