Phase 1 Bladder 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 a metastatic genitourinary cancer (a cancer affecting the urinary or reproductive system, but not prostate cancer), confirmed by a laboratory test on a tissue or cell sample.
• People whose cancer has spread or grown, shown by a scan taken within the past 21 days.
• People whose cancer can be measured or assessed using standard imaging (a system called RECIST 1.1).
• People in certain trial groups (Arms 2 and 3) who have at least one area of cancer that could be treated with radiation (up to 4 different areas may be treated).
• People who have at least one measurable area of cancer that will not be treated with radiation during the trial.
• People who have previously had chemotherapy or targeted drug treatments, or who have not had any prior treatment.
• People who have previously had radiation therapy, though re-treating a previously irradiated area is only permitted with specific approval from the trial leadership.
• People who have previously had immune-based therapies, including checkpoint inhibitor drugs, as long as they have not previously received the specific study drugs M7824 or PDS01ADC.
• People with advanced or metastatic clear cell kidney cancer who have previously received, declined, or been found ineligible for certain standard treatments (including combinations such as axitinib plus pembrolizumab, cabozantinib plus nivolumab, and several others listed in the criteria).
• People with advanced or metastatic germ cell tumours who have previously received, declined, or been found ineligible for certain standard chemotherapy regimens or a stem cell transplant.
• People with advanced or metastatic bladder or urinary tract cancer who have previously received, declined, or been found ineligible for platinum-based chemotherapy and/or a PD-1/PD-L1 inhibitor drug.
• People for whom a tumour tissue sample is available for testing, or who are willing to have a biopsy taken before treatment begins if existing samples are not suitable.
• People aged 18 or older on the day they sign the consent form.
• People who are reasonably active and able to care for themselves, as measured by a standard health performance scale (ECOG score of 0, 1, or 2).
• People whose blood counts and organ function meet specific minimum levels, including adequate white blood cells, infection-fighting cells, platelets, haemoglobin, and liver enzyme levels (confirm specific values with the trial site).
• People with mild to moderate liver impairment, provided certain liver-related blood test results stay within defined limits.
• People whose kidneys are functioning at a minimum level, as measured by a calculated kidney function test (confirm with trial site).
• People of childbearing potential, and people who are able to father a child, who agree to use effective contraception during treatment and for a set period after the last dose (at least 65 days for those who could become pregnant, and 125 days for those who could father a child).
• People living with HIV who are on a stable dose of antiretroviral medication, have an adequate immune cell count (CD4 above 350 cells/mm³), and have an undetectable viral load.
• People who have previously treated brain or central nervous system tumours, provided they have recovered from any side effects of that treatment, are no longer taking steroids for it, and the radiation was completed at least 2 weeks before starting this trial.
• People with Hepatitis B who are on a stable dose of approved antiviral medication at the time of joining, with ongoing monitoring planned.
• People with Hepatitis C who are currently receiving Hepatitis C treatment, are on a stable dose, and have no significant related liver or blood abnormalities, with ongoing monitoring planned.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who have had a serious allergic reaction to drugs that are chemically or biologically similar to the study drugs M7824 or PDS01ADC.
• People with serious uncontrolled health conditions, such as severe heart failure, unstable chest pain, irregular heart rhythms, or psychiatric or personal circumstances that would make it difficult to follow the trial requirements. People considered at high risk of serious bleeding events (other than blood in the urine) are also excluded.
• People who are unwilling to receive blood products if medically needed.
• People who are currently pregnant or breastfeeding, as the study drugs may be harmful to an unborn baby or infant.
• People with an active or recent history of an autoimmune disease, or a condition that has required treatment with higher-dose steroid medications or immune-suppressing drugs (low-dose inhaled or replacement steroids may be acceptable). People with inflammatory bowel disease that has been in remission for at least 5 years may still be eligible, provided they are not on high-dose steroids (confirm with trial site).
• People with active or recent inflammatory bowel disease, active lupus, scleroderma, certain lung conditions, or inherited conditions that make the body particularly sensitive to radiation — unless the principal investigator determines it is safe for them to participate.
• People who currently have another active cancer, other than certain low-risk skin cancers, early-stage cervical abnormalities, or a very early-stage, low-risk prostate cancer found incidentally during surgery. People who completed treatment for another cancer at least 2 years ago and show no signs of that cancer returning, and who do not need ongoing treatment for it, may still be eligible.
• People who have one or more tumours in the liver or chest that are 10 cm (about 4 inches) or larger.

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