Phase 3 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:

• You must be 18 years old or older (or meet the legal age of consent in your country) at the time you sign the consent form.
• You must have been diagnosed (confirmed by a lab test of tissue or cells) with a type of bladder or urinary tract cancer called urothelial carcinoma that either cannot be surgically removed, has spread locally, or has spread to other parts of the body — this includes cancer starting in the bladder, kidney, ureter, or urethra.
• Mixed cancer cell types may be allowed, as long as the main type is urothelial carcinoma (confirm with trial site).
• If you have a history of prostate cancer that is not currently active or spreading, you may still be eligible under certain conditions (confirm with trial site).
• If your cancer came back during or within 12 months of receiving certain early-stage (neoadjuvant/adjuvant) treatments, you may be considered with special approval from the trial team (confirm with trial site).
• You must be able to provide a tumor tissue sample — either from a previous biopsy stored within the last 12 months, or from a new biopsy before treatment starts.
• You must be considered well enough by your doctor to receive a chemotherapy regimen containing either cisplatin or carboplatin.
• Your cancer must have gotten worse (shown on scans) during or after receiving a first-line treatment combination of enfortumab vedotin (or a similar drug) and pembrolizumab (or a similar immunotherapy drug).
• If you stopped that first-line treatment early due to side effects, you may still be eligible if your cancer has since progressed (confirm with trial site).

Who may not be able to join:

• You have received any other systemic (whole-body) cancer treatment for advanced or metastatic urothelial carcinoma beyond the enfortumab vedotin and pembrolizumab combination — though exceptions may be considered with special approval (confirm with trial site).
• You have previously had a bone marrow transplant or a solid organ transplant (such as a kidney or liver transplant).
• You have previously been treated with a drug that specifically targets a protein called TROP2 (a type of targeted cancer therapy).
• You are currently taking any medications that are not allowed in this trial (confirm with trial site for the specific list).
• You have significant heart problems, including a recent heart attack within the last 6 months, uncontrolled chest pain, certain types of heart failure, uncontrolled high blood pressure, or an abnormal heart rhythm reading on an ECG test.
• You have a history of, or currently have, a lung condition called ILD (interstitial lung disease) or pneumonitis (lung inflammation) — including a type caused by radiation — that required steroid treatment, or if this cannot be ruled out at screening.
• You have serious lung problems that your doctor considers severe, such as severe asthma, severe COPD, significant fluid around the lungs, or certain autoimmune or inflammatory conditions affecting the lungs, or if you have had an entire lung surgically removed.
• You still have significant side effects from previous cancer treatments that have not improved — with some exceptions for certain stable, mild ongoing side effects such as nerve-related symptoms, some hormone or thyroid problems from prior immunotherapy, or skin pigmentation changes (confirm with trial site).

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