Phase 2 Kidney Cancer 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 been diagnosed with locally advanced or metastatic renal medullary carcinoma (RMC) or epithelioid sarcoma (ES), confirmed by specialist pathology review, or a rare related kidney cancer variant that is SMARCB1-negative but occurs in people without sickle cell disease.
• People whose cancer shows a certain protein called CA-125 (MUC16) — either detected at a high enough level in a blood test (≥70 units/ml), or shown to be present at a sufficient level in tumour tissue tested within the past 12 months (confirm specific thresholds with trial site).
• People in the RMC group regardless of whether they have had kidney surgery or still have the original tumour in place.
• People who have at least one tumour that can be measured on a scan (generally at least 15mm using standard imaging, or at least 10mm with more detailed scans such as MRI or CT).
• People whose cancer has continued to grow or spread after at least one previous treatment.
• People who are generally active and able to care for themselves, with only limited restrictions on physically demanding activity (referred to medically as ECOG performance status 0–1); people who use a wheelchair due to paralysis but are otherwise mobile may also meet this requirement.
• People aged 18 years or older at the time of signing consent (the trial may later consider participants aged 12 and over, subject to safety review — confirm with trial site).
• People who are willing to consent to a companion laboratory research protocol at MD Anderson (protocol 2014-0938).
• People whose blood counts and organ function meet specific minimum levels, including haemoglobin, white blood cells, platelets, liver enzymes, bilirubin, and kidney function — as determined by the trial team through blood tests.
• People who have brain metastases that have already been treated (by surgery or targeted radiation) and have been stable without recurrence or swelling for at least one month, and who are not currently needing steroid medications to control brain swelling.
• Women of childbearing potential who have a negative pregnancy test within 24 hours before starting the study drug.
• People who agree to use effective contraception during treatment and for a set period after treatment ends (5 months for women of childbearing potential; 7 months for men).
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have had another cancer in the past 2 years, with some exceptions such as certain skin cancers, early-stage cervical cancer, ductal carcinoma in situ of the breast, or very low-risk early prostate cancer (confirm with trial site).
• People who have previously been treated with certain types of antibody therapies that redirect T-cells, or any therapy specifically targeting the CA-125 (MUC16) protein, including vaccines; or people who received CAR-T cell therapy within the past 30 days.
• People who are currently receiving cancer treatment, or who received chemotherapy or targeted therapy within the past 14 days.
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments that could interfere with detecting new side effects from the study drugs.
• People who have had major surgery or a serious injury within the past 4 weeks, or who have not yet fully recovered from a major surgery.
• People who have received an organ transplant from another person.
• People with known or suspected autoimmune diseases such as rheumatoid arthritis, lupus, scleroderma, inflammatory bowel disease, or autoimmune vasculitis; some milder autoimmune conditions such as thyroid disease managed with hormone replacement, type 1 diabetes, or mild psoriasis not requiring systemic treatment may still be eligible (confirm with trial site).
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed immune deficiency condition; people with controlled versions of these infections under specific conditions may still be eligible (confirm with trial site).
• People with an underlying medical condition that the trial doctor believes would make the study drug unsafe or make it difficult to interpret side effects, including active COVID-19 infection.
• People who are scheduled to receive another experimental drug during the study.
• People currently taking high-dose steroids (e.g., more than 10mg prednisone daily or equivalent) or strong immune-suppressing medications; low-dose topical or inhaled steroids are generally permitted (confirm with trial site).
• People whose heart pumping function (left ventricular ejection fraction) was measured below 50% within the past 6 months; cases where the result was 45–50% may be reviewed by a heart specialist before a decision is made (confirm with trial site).
• People with active inflammation of the heart muscle (myocarditis).
• People with a moderate to large fluid collection around the heart, as detected by echocardiogram.
• People with a history of a clinically significant heart rhythm problem, or who have a pacemaker or defibrillator implanted.
• People with serious or uncontrolled heart conditions, including severe heart failure, unstable chest pain, a heart attack within the past 6 months, or uncontrolled arrhythmia.
• People with an active uncontrolled infection (bacterial, viral, fungal, or other).
• People with a history of serious psychiatric illness that the trial doctor believes would prevent them from fully understanding the study and its risks.
• People with other medical conditions, abnormal test results, or findings that the trial doctor believes could make the study drugs unsafe or affect the interpretation of results.
• People who have received a live attenuated vaccine within 30 days before planned start of the study drug (standard injected flu vaccines are generally allowed; nasal spray flu vaccines are not).
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective birth control as required by the trial.
• People who are unable or unwilling to attend the appointments required by the trial schedule.
• People with a known history of serious allergic reactions to compounds similar in composition to the study drugs (ubamatamab or cemiplimab).
• People with psychiatric illness or personal circumstances that would make it difficult to follow the trial's requirements.

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